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Back to jobs Associate Director, GMP Quality Boston, MA; New York, NY Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position The Associate Director, GMP Quality Assurance is responsible for ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling, storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC development activities, audits CDMOs, conducts batch release, and performs investigations. The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment. Additionally, the role explores opportunities to integrate artificial intelligence (AI) technologies to improve efficiency, compliance, and overall quality assurance practices. Responsibilities Ensure compliance with global regulations (e.g., FDA, EMA, ICH) and internal SOPs. Policies and Work Instructions Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports Perform QA review of executed batch records, supporting manufacturing documents, and testing results to support timely and compliant batch disposition Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events Conduct internal audits to assess compliance and identify improvement opportunities Conduct the qualification and periodic assessment of suppliers, CDMOs, laboratories, and service providers Review and maintain Quality Agreements, ensuring external partners meet GMP expectations Support preparation for and participation in regulatory inspections and due diligence audits Apply risk management principles (e.g., FMEA) to guide decision-making Champion a culture of quality, transparency, and continuous improvement About You Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences) Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance, with specific experience in biologics / large-molecule manufacturing and testing Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety Excellent communication, organization, and collaboration skills Ensures accuracy and completeness in documentation and decision-making Ability to lead investigations and write clear, concise supporting documents Experience with CMO oversight or virtual manufacturing models Thrive in a dynamic, fast-paced environment with evolving priorities Total Compensation Range: $161,500 - $202,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Get new jobs like this in your inbox We'll email you when Formation Bio posts a job like this one. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you legally authorized to work in the United States?* Select... Are you located in or willing to relocate to NYC, NY or Boston, MA?* Select... What AI tools have you used, whether in your personal or work life?* Where are you most excited for AI to help your function?* If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... How did you hear about this job?* Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Bio + Health

89 days ago

Vice President, Clinical Operations

Formation Bio · Boston, MA

Pay

$350k–425k

Setting

On-site

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Current openings at Formation Bio Create a Job Alert Level-up your career by having opportunities at Formation Bio sent directly to your inbox. Create alert Search 20 jobs Business Development Job Director, Business Development - Search & Evaluation Boston, MA Development Clinical Development Job Associate Director, Pharmacology Boston, MA; New York, NY Development CMC Job Associate Director, Analytical Development & QC Boston, MA; New York, NY Associate Director, Bioanalytical Development Boston, MA; New York, NY Development Program Management Job General Manager (Drug Asset Lead) Boston, MA; New York, NY Development Quality Assurance Job Associate Director, GMP Quality Boston, MA; New York, NY Director/Senior Director of Asset Quality Assurance Boston, MA; New York, NY Marketing Job Director, Brand & Communications New York, NY; Boston, MA People Job Director, People New York, NY; Boston, MA Lead Technical Recruiter New York, NY; Boston, MA Tech Data Science Job Associate Director, Data Science (Real World Data) Boston, MA; New York, NY Data Scientist, Portfolio Optimization New York, NY; Boston, MA Director, Data Science Boston, MA; New York, NY Principal Data Scientist New York, NY; Boston, MA Principal Data Scientist, Medical Imaging New York, NY; Boston, MA Senior Data Scientist New York, NY; Boston, MA Senior Data Scientist, Medical Imaging Boston, MA; New York, NY Senior Data Scientist - Real World Data New York, NY; Boston, MA; San Francisco, CA; Raleigh-Durham, NC Tech Engineering Job Software Engineer (Open Level) New York, NY; Boston MA; San Francisco, CA Tech Product Job Senior Director or Vice President, Product New York, NY; Boston MA Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Bio + Health

132 days ago

Associate Director, Data Science (Real World Data)

Formation Bio · Boston, MA

Pay

$214k–267k

Setting

On-site

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Back to jobs Associate Director, Data Science (Real World Data) Boston, MA; New York, NY Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position As Associate Director of RWD Intelligence at Formation Bio, you will lead the strategy and execution of our real-world data (RWD) capabilities, building the data foundations that power drug acquisition, clinical development, and portfolio decision-making. You will own the end-to-end lifecycle of RWD: sourcing, procurement, ingestion, harmonization, quality assurance, and delivery of analysis-ready datasets to downstream consumers across Product, Data Science, Clinical Development, and Business Development. This role sits at the intersection of data engineering, data science, and drug development. You will build and maintain scalable data infrastructure (pipelines, data models, lakes/marts) while ensuring semantic interoperability across heterogeneous data sources through ontology-driven harmonization frameworks such as OMOP. You will also manage vendor relationships and data procurement, evaluating and integrating new data assets as the portfolio evolves. The ideal candidate combines deep RWD domain expertise with strong data fluency, enabling Formation Bio to treat real-world evidence as a first-class strategic asset. Responsibilities Lead the RWD Intelligence function within Data Science, owning data strategy, sourcing, and delivery of analysis-ready datasets Architect and maintain the supporting infrastructure (pipelines, ingestion workflows, data models, lakes/marts) across EHR/EMR, claims, registries, and genomics-linked cohorts Drive adoption and extension of harmonization frameworks (e.g., OMOP CDM) across heterogeneous data sources, leveraging AI/ML tools for entity resolution, ontology mapping, data quality monitoring, and automated harmonization Manage RWD vendor relationships end-to-end: evaluate providers, negotiate data use agreements, broker new partnerships, and integrate acquired datasets into the platform Partner with Data Science, Clinical Development, Business Development, and Engineering teams to define RWD use cases (trial feasibility, synthetic control arms, epidemiology, label expansion) and productize ad hoc pipelines into scalable, production-grade systems Foster a culture of data quality rigor, documentation, and reproducibility across all RWD assets About You Required Qualifications BSc or MSc in biomedical informatics, computational sciences, epidemiology, or a related quantitative field 5+ years of industry experience working directly with real-world data (EHR/EMR, claims, registries, linked biobank data) in pharma, biotech, health tech, or consulting, with at least 2+ years in people management Strong data engineering proficiency (pipelines, ingestion frameworks, data models, data lakes/marts) combined with deep working knowledge of biological and medical ontologies (ICD, SNOMED CT, MedDRA, RxNorm, ATC) and harmonization standards, particularly OMOP CDM Demonstrated experience with RWD procurement and vendor management: evaluating data providers, negotiating agreements, and integrating new data assets Proven ability to deliver RWD-derived insights across multiple drug development use cases (e.g., trial design, epidemiology, comparative effectiveness, label expansion), with familiarity across the development lifecycle from target selection through post-market Proficiency with modern AI/ML tools, including large language models, and their applications in data engineering and harmonization workflows Strong communication skills with the ability to translate complex data infrastructure concepts for clinical, scientific, and executive audiences Preferred Qualifications PhD in biomedical informatics, epidemiology, computational biology, or a related field Experience with large-scale biobank and genomics-linked RWD platforms (UK Biobank, FinnGen, All of Us), with a track record of building RWD infrastructure that directly influenced drug acquisition, licensing, or portfolio decisions Familiarity with additional biomedical data modalities (scientific literature mining, -omics datasets, molecular data integration) and with data science/analytics methodologies applied to RWD (causal inference, trial simulation, propensity score methods) Background transitioning data infrastructure from research/ad hoc to production-grade systems in regulated environments Experience working at the intersection of data engineering, data science, and business strategy in pharma/biotech Total Compensation Range: $213,500 - $267,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Get new jobs like this in your inbox We'll email you when Formation Bio posts a job like this one. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile How did you hear about this job? Have you previously worked in drug development?* Select... Are you legally authorized to work in the United States?* Select... If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... Are you within 60 miles commutable distance to our midtown Manhattan office or the Downtown Boston area?* Select... If you are not located within commuting distance from one of our hubs, are you willing to relocate? Select... What AI tools have you used, whether in your personal or work life?* What is your highest level of education* Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Bio + Health

189 days ago

Associate Director, Analytical Development & QC

Formation Bio · Boston, MA

Pay

$178k–232k

Setting

On-site

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Back to jobs Associate Director, Analytical Development & QC Boston, MA; New York, NY Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team. This role will provide broad exposure across Formation Bio’s portfolio, requiring the ability to flex between small molecule and biologics programs at different phases of development in an outsourced development model, requiring strong technical skillset, vendor management, and the ability to balance scientific rigor with program timelines. You will play a key role in providing technical leadership as a subject matter expert for the development, optimization, and validation of drug substance and drug product analytical methods to support outsourced development and manufacturing of small molecule and biologics programs including but not limited to proteins, monoclonal antibodies, and vaccines. In this role you will also oversee all Formation Bio stability programs and closely collaborate with CMC, QA, and Regulatory teams. Responsibilities In close collaboration with CDMOs and contract testing laboratories, lead development, optimization and validation of phase-appropriate analytical methods for small molecule and biologics drug substances and drug products. Manage testing (in-process, release, stability) at CDMOs and contract testing laboratories. Provide technical oversight for method transfers, comparability assessments, and laboratory readiness. Lead selection, qualification, and ongoing performance management of external analytical vendors. Oversee and manage Formation Bio’s stability studies across all programs, including review and approval of stability protocols and review and trending of stability data to support shelf-life and retest dating. Track and publish stability program metrics. Act as the primary contact for stability-related inquiries. Oversee and manage Formation Bio’s critical reagents and reference standards inventory and testing. Lead investigations of release and stability OOS and OOT results, deviations, CAPAs and change controls. Author and review analytical sections of CMC documents, including protocols, reports, and regulatory submissions. Author and review of SOPs and work instructions. Closely collaborate with CMC, QA, and Regulatory teams. About You Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline Master’s degree with 5+ years or Bachelor’s Degree with 8+ years of relevant small molecule and biologics analytical development and QC experience. Proven ability to operate effectively in a fast-paced, virtual, and outsourced development environment. Highly organized with a track record of managing multiple priorities across programs in an outsourced development model. Strong scientific judgment with the ability to independently assess data quality, identify risks, and recommend mitigation strategies. Ability to communicate complex analytical concepts clearly to both technical and non-technical stakeholders. Collaborative mindset with a strong sense of ownership and accountability. Extensive hands-on experience developing, optimizing, and validating analytical methods for release and stability testing of small molecules and biologics. Hands-on experience with analytical methods pertinent to bilogics (qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.) and small molecules (UHPLC, IC, GC, IR, UV, KF, PSD, dissolution, etc.). Experience with authoring and reviewing technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest and shelf-life memos, and SOPs. Experience with designing stability studies and performing stability data trending according to applicable guidances. Strong working knowledge of Smartsheet and JMP. Thorough understanding of ICH, FDA, EMA guidances and GMP requirements governing process development, manufacturing, and stability. Ability to travel domestically and internationally up to 25% of the time. Total Compensation Range: $177,500 - $232,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you legally authorized to work in the United States?* Select... Where are you most excited for AI to help your function?* What AI tools have you used, whether in your personal or work life?* Are you located in or willing to relocate to NYC, NY or Boston, MA?* Select... If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... How did you hear about this job?* Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. 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Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Bio + Health

211 days ago

Associate Director, Pharmacology

Formation Bio · Boston, MA

Pay

$178k–232k

Setting

On-site

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Back to jobs Associate Director, Pharmacology Boston, MA; New York, NY Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position Formation Bio is seeking an Associate Director, Pharmacology to join our Development team. In this role, you will help shape and execute pharmacology strategy across development programs, applying broad pharmacology expertise, first-principles scientific thinking, and rigorous translational judgment to advance assets efficiently and credibly. You will contribute to preclinical pharmacology strategy, support drug development and business development activities, and help define the studies and evidence packages needed to make high-quality program decisions. This role is well suited for a scientifically rigorous, intellectually independent pharmacologist who can move fluidly across mechanisms, modalities, disease areas, and stages of development, with particular value placed on familiarity with immunology, animal models, and AI-enabled scientific workflows. The role reports to the Director of Pharmacology and you will be a key member of the Formation Bio Development team. Responsibilities Execute and contribute to preclinical pharmacology strategy across development programs, with studies primarily executed through CROs Design, oversee, and interpret pharmacology studies to characterize mechanism of action, target biology, in vivo proof of concept, dose-response, pharmacodynamic activity, exposure-response relationships, and asset progression Develop integrated pharmacology plans covering efficacy, target engagement, receptor binding, selectivity, biomarkers, PK/PD, translational hypotheses, safety margins, therapeutic index, dose rationale, and key decision points Apply first-principles scientific reasoning and broad pharmacology perspective to evaluate biological rationale, identify critical assumptions, pressure-test hypotheses, distinguish decision-critical data from interesting findings, and design focused studies to address key scientific, regulatory, or translational questions Partner with DMPK, Toxicology, Clinical Pharmacology, Clinical Development, Regulatory, CROs, and external partners to integrate pharmacology into development strategy, regulatory materials, in-licensing evaluations, and interactions with regulators, partners, advisors, and internal leadership Manage CRO-executed pharmacology studies and related workflows, including protocol review, vendor oversight, data quality, timelines, budgets, study conduct, interpretation, final reports, organizational tracking systems, and use of technology, modeling, data analytics, literature mining, and AI-enabled tools to improve speed, rigor, reproducibility, and decision-making About You PhD in Pharmacology, Biology, Immunology, Translational Sciences, or a related field, with 4-6+ years of relevant post-PhD biopharma industry experience; level will be commensurate with experience Broad, hands-on expertise in preclinical pharmacology, including mechanism of action, disease biology, in vivo efficacy models, dose-response, target engagement, biomarkers, selectivity, and PK/PD Strong first-principles scientific judgment, with evidence of original thinking, rigorous hypothesis generation, incisive experimental design, and the ability to interpret complex or ambiguous data Experience designing, overseeing, and interpreting animal studies, including model selection, endpoint strategy, dosing rationale, exposure-response relationships, and translational limitations Experience developing pharmacology strategies that support candidate selection, IND-enabling work, clinical development, lifecycle management, regulatory submissions, or externally sourced assets Strong understanding of how preclinical pharmacology informs translational hypotheses, dose rationale, safety margins, therapeutic index, biomarker strategy, and regulatory positioning; familiarity with immunology, immune-mediated disease biology, or immunomodulatory mechanisms preferred Experience working cross-functionally with DMPK, Toxicology, Clinical Pharmacology, Clinical Development, Regulatory, CROs, and external partners, including management of CRO-executed studies, protocols, data quality, timelines, budgets, and reports Highly organized, collaborative, and intellectually curious scientist with excellent communication skills, strong scientific rigor, comfort in fast-paced environments, and enthusiasm for using technology, modeling, data analytics, and AI-enabled approaches to improve pharmacology research and decision-making Compensation Range: $177,500 - $232,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Get new jobs like this in your inbox We'll email you when Formation Bio posts a job like this one. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you legally authorized to work in the United States?* Select... Where are you most excited for AI to help your function?* What AI tools have you used, whether in your personal or work life?* Are you located in or willing to relocate to NYC, NY or Boston, MA?* Select... If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... How did you hear about this job?* Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Bio + Health

223 days ago

Senior Director, Clinical Pharmacology

Formation Bio · Boston, MA

Pay

$311k–388k

Setting

On-site

Apply Sign in to favorite Permalink

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