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Engineer, Manufacturing Sciences & Technology (MSAT) (3rd Shift)
Orca Bio · Sacramento, CA
$85k–105k
36 days ago
♡
Statistician, CMC (Chemistry, Manufacturing, and Controls)
Orca Bio · Menlo Park, CA
$100k–160k
36 days ago
♡
Engineer, Manufacturing Sciences & Technology (MSAT) (3rd Shift)
Orca Bio · Sacramento, CA
$85k–105k
36 days ago
♡
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Medical Science Liaison - Southwest
Orca Bio · Remote
Pay
$195k–245k
Setting
Remote
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary:
The MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Southern California, Arizona, New Mexico, or Colorado.
\n- Serve as a subject matter expert in stem cell transplantation, cell therapy, and the evolving cellular immunotherapy landscape, providing scientific insights regarding current treatment paradigms, clinical operations, patient access and emerging competitive landscape
- Identify, develop, and maintain deep scientific, peer-to-peer relationships with academic stem cell therapy experts as well as thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific and product related questions, to ensure their safe and appropriate use of Orca Bio products through peer-to-peer discussions aligned with medical strategies and needs expressed by external stakeholders
- Prepare and maintain a territory management plan that will be shared with Medical Leadership and other internal stakeholders
- Engage with Orca “Pod” field team members to provide appropriate medical support for all onboarding activities in relation to authorizing treatment centers, adverse event reporting, handling out of spec products, as well as partnering with regional Market Access colleagues to provide medical education and support to local payers in alignment with Market Access tactical plan and individual patient needs
- Develop and maintain a deep and current understanding of hematologic malignancies, stem cell transplantation, cell therapy, cellular immunotherapy and competitive developments to facilitate high level scientific exchange with health care professional and key opinion leaders
- Actively assess the transplant and cell therapy landscape through ongoing engagement with key opinion leaders, investigators, and academic research centers to identify emerging scientific trends, evidence gaps, and novel research opportunities relevant to Orca Bio's therapies. Serve as the primary liaison for Orca Bio's Investigator-Sponsored Trial (IST) program, partnering with investigators to develop and refine research concepts, evaluate scientific merit and strategic alignment, support proposal and protocol development, present qualified concepts to review committees, communicate governance decisions, and provide scientific oversight throughout study start-up, conduct, publication planning, and dissemination of results
- Gather and communicate actionable scientific insights and stakeholder feedback to Orca Bio leadership and cross-functional partners to inform medical strategy, evidence generation priorities, and lifecycle planning
- Provide scientific and clinical expertise to support internal and external stakeholders, through participation in advisory board meetings, clinical investigator meetings, roundtable discussions, educational meetings, interactions with professional organizations/societies, advocacy groups, GPOs, and large networked practices as needed, including speaker bureaus
- Support clinical trial activities to enhance patient recruitment, enrollment and/or discussions around the safe and effective use of Orca Bio investigational products, leveraging clinical trial experience and knowledge of Good Clinical Practice (GCP) to ensure adherence to ethical and regulatory standards
- Lead the collection, analysis, synthesis and dissemination of scientific information presented at congresses and during scientific exchange. Translate emerging clinical trial data, competitive intelligence and external stakeholder feedback into actional recommendations for Orca Bio leadership and cross functional teams. When assigned, coordinate the efforts of other MSLs to provide coverage for a specific congress to maximize organizational impact
- Provide medical and scientific support of the strategy of health outcomes, real-world evidence, and payer/provider engagements
- Initiate and autonomously execute projects that align with Orca Bio’s scientific, clinical and business operations partnering with research, clinical development, commercial, market access, regulatory, and quality functions to drive company strategy
- Provide education and training to commercial marketing and sales teams on therapies and disease states
- Advanced clinical degree in a life-science or basic-science discipline (MD, DO, PharmD, NP, PA, DNP, M.Sc, or Ph.D.) and industry experience as an MSL
- Significant clinical and/or industry experience in malignant hematology, hematopoietic stem cell transplant (HSCT), cellular therapy, CAR-T, immune effector cell therapies, and/or other advanced therapy modalities
- Strong understanding of cell therapy ecosystem, including transplant center operations, apheresis and cell processing workflows, treatment center authorization, patient referral pathways and competitive cell therapy products
- Strong understanding of clinical development, regulatory requirements, and commercial strategies; experience with HEOR data is a plus
- Excellent interpersonal and communication skills, with the ability to engage and influence a wide range of stakeholders
- Demonstrated ability to interpret and present complex scientific data to diverse audiences
- Strong strategic thinking, problem-solving skills, and solution-oriented mindset
- Demonstrated ability to collaborate with cross-functional colleagues to best serve the needs of internal and external stakeholders
- Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment
- 5+ years of industry experience as an MSL
- Demonstrated experience with field medical launch planning, execution, and post-launch support
- Direct experience supporting cell therapy, stem cell transplantation, CAR-T or other advanced therapeutic platforms
- Experience working in a small biotech company or start-up environment
$195,000 - $245,000 a year
\nThe anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Medical Science Liaison - Southwest
Orca Bio · Remote
Pay
$195k–245k
Setting
Remote
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary:
The MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Southern California, Arizona, New Mexico, or Colorado.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Medical Science Liaison - Southeast
Orca Bio · Remote
Pay
$195k–245k
Setting
Remote
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary:
The MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Florida, South Carolina, Georgia, Alabama, Mississippi, Louisiana, or Arkansas.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Specialist, Logistics (Night Shift)
Orca Bio · Sacramento, CA
Pay
$60k–90k
Setting
On-site
Specialist, Logistics (Night Shift)
Sacramento, CAOperations – Logistics & Product Supply /Regular, Full-Time Employee /On-Site
APPLY FOR THIS JOB
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio's manufacturing sites and transplant centers. This role owns real-time coordination of active courier runs and carries full, on-the-spot decision-making authority during disruptions — trusted to rebook travel and redirect couriers in the moment to keep product moving toward the treatment center as fast as possible — along with chain-of-custody documentation and vein-to-vein KPI tracking, and partners closely with internal stakeholders and external donor and recipient organizations. As part of a cross-trained team, the Specialist also serves as backup coverage for packaging operations during surge periods. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.
Night Shift Hours Worked:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday
Physical Demands
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Work Conditions
Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
Essential Duties & Key Responsibilities:
Real-Time Transport Monitoring
• Provide live tracking of courier flights throughout active runs.
• Serve as the point person for monitoring incoming weather systems for the upcoming week or so, flagging potential impacts early and planning effectively to keep runs on schedule, in addition to tracking real-time weather and emergency events that may affect active transport.
• Maintain daily communication with Orca Porters during active runs.
• Actively monitor shipments and resolve delays or issues in real time.
• Participate in on-call coverage during active courier transports to handle non-routine issues.
• Manage up to 8 concurrent incoming and outbound transports at a time, seeing every issue that arises across them through to resolution.
Disruption & Incident Response
• Serve as the trusted, in-the-moment decision-maker when a disruption hits: you are fully empowered to independently rebook flights, hotels, and ground transport, re-route the courier, and take whatever action gets the courier and product to the treatment center as fast as possible, without waiting on sign-off.
• Rebook delayed flights and hotels, and re-issue itineraries and TSA letters as travel plans change.
• Assess the impact of flight delays on batch and delivery timelines, including triage with manufacturing and scheduling.
• Manage third-party delays and issues routed through the courier, and negotiate third-party itineraries.
• Lead courier incident management (personnel), clean up incident paperwork, and follow up with TSA and couriers on potential and actual changes.
• Communicate changes urgently and professionally to all impacted stakeholders.
Chain of Custody, Data & KPIs
• Upload chain-of-custody (CoC) and third-party records; verify temperature data; and track the return of materials.
• Update delivery times in OrcaLink and capture vein-to-vein (V2V) times for KPI reporting.
• Ensure all documentation and compliance requirements for pickups and deliveries are met.
Courier Program & Vendor Coordination
• Schedule couriers for donor cell pickups and deliveries, and coordinate outbound drug product shipments to recipient sites.
• Manage flight and travel logistics for couriers, liaising with airlines and travel providers.
• Lead third-party courier implementation and troubleshoot transportation issues as they arise.
• Review and approve courier invoices, and track and optimize courier performance.
• Conduct commercial site feasibility assessments for new and existing treatment centers, and support dry-run paperwork.
• Partner with clinical schedulers and commercial case managers to troubleshoot and triage non- routine issues during transports.
Cross-Coverage & Continuous Improvement
• Serve as cross-trained backup for night packaging operations during surge or coverage gaps, covering coordination-adjacent, non-aseptic tasks: Credo and dry-shipper charging and preparation, asset checkout and batch assignment in TrakSYS, final packing/handover and CoC, shipping-condition confirmation, temperature-data upload, and asset recirculation.
• Continuously evaluate and improve logistics workflows to support operational scalability.
• Contribute to training materials and ensure the courier team remains compliant and current.
• Assist with additional logistics and operations-related projects as needed.
Minimum Experience, Education, Certifications, Licenses:
• Bachelor's degree and 2–3 years of relevant logistics experience required. B.S. in biology, life sciences, or logistics preferred.
• Proven success in logistics coordination, preferably in a regulated environment.
• Familiarity with handling biological materials and associated transportation regulations is a plus.
• Proficiency in logistics tracking systems or software required.
Preferred Experience:
• Logistics or courier coordination in fast-paced, time-sensitive industries (e.g., healthcare, biotech, or medical transport).
• Working with regulated materials, such as biological specimens or pharmaceuticals, with knowledge of chain-of-custody, IATA, or DOT compliance.
• Real-time problem-solving and communication during transport disruptions or delays.
• Managing relationships with vendors, third-party couriers, airlines, and internal stakeholders simultaneously.
• Exposure to continuous improvement efforts, workflow scaling, or SOP development.
• Familiarity with logistics tools and platforms such as shipment tracking systems, Google Workspace, Smartsheet, or equivalent.
• Prior dispatcher experience.
Personal Qualities:
• Highly detail-oriented, with an unwavering commitment to quality, safety, and compliance.
• Takes ownership and drives forward without waiting for instruction.
• Is naturally curious, eager to learn, and energized by solving problems.
• Brings creative solutions to unexpected challenges.
• Is comfortable juggling multiple priorities in a fast-paced, startup environment.
• Communicates clearly and professionally with internal and external stakeholders.
• Works both independently and collaboratively with a team-first mindset.
• Stays calm under pressure and adapts quickly to change.
• Embraces a positive attitude, a collaborative spirit, and a good sense of humor
$60,000 - $90,000 a year
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
APPLY FOR THIS JOB
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Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Specialist, Logistics (Night Shift)
Orca Bio · Sacramento, CA
Pay
$60k–90k
Setting
On-site
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio's manufacturing sites and transplant centers. This role owns real-time coordination of active courier runs and carries full, on-the-spot decision-making authority during disruptions — trusted to rebook travel and redirect couriers in the moment to keep product moving toward the treatment center as fast as possible — along with chain-of-custody documentation and vein-to-vein KPI tracking, and partners closely with internal stakeholders and external donor and recipient organizations. As part of a cross-trained team, the Specialist also serves as backup coverage for packaging operations during surge periods. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.
Night Shift Hours Worked:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Engineer, Manufacturing Sciences & Technology (MSAT) (3rd Shift)
Orca Bio · Sacramento, CA
Pay
$85k–105k
Setting
On-site
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
Engineer I, MSAT, works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. The Engineer I works on well-defined problems with clear scope and known troubleshooting paths, typically under guidance from more senior engineers or a manager.
\n- Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
- Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
- Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
- Must be comfortable regularly participating in video-based meetings.
- May be required to work scheduled overtime, weekends, or holidays based on business needs.
- Performs ongoing monitoring of existing commercial products and processes
- Generates metrics and reports for process monitoring and continuous process verification
- Supports process improvements and changes including electronic batch record creation and modifications
- Investigates process events and implements corrective and preventive actions
- Provides troubleshooting support for manufacturing events, equipment performance and material issues
- Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
- Supports the authoring, execution and ownership of change controls, CAPAs, technical protocols, reports and activities to support improvements
- Ensures proper execution of validation protocols and testing in line with required life cycle management activities
- Troubleshoots issues within a defined scope, seeking guidance from senior team members as needed
- Supports validation activities, technical studies, and process improvement projects under the direction of senior engineers
- Learns from experienced engineers and contributes to collaborative problem-solving efforts
- B.S. in Engineering or similar fields, or equivalent combination of education and directly relevant experience
- 0-2 years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
- Prior experience in regulated, GMP manufacturing operations
- Experience in biotechnology and cell therapy manufacturing preferred
- Strong communication and problem-solving skills, with a desire to improve upon established
processes
3rd Shift:
• Monday - Friday, 11:00pm - 7:00am
$85,000 - $105,000 a year
\nThe anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Statistician, CMC (Chemistry, Manufacturing, and Controls)
Orca Bio · Menlo Park, CA
Pay
$100k–160k
Setting
On-site
Statistician, CMC (Chemistry, Manufacturing, and Controls)
Menlo Park, CAScience – Chemistry, Manufacturing & Controls /Regular, Full-Time Employee /On-Site
APPLY FOR THIS JOB
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: We are seeking a skilled Statistician to join our CMC organization and provide statistical leadership across analytical method development, validation, comparability, and product characterization activities. The successful candidate will partner closely with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data (including non-normal distributions common in biologics assays), and translate results into clear, regulatory-defensible conclusions that support process and product decisions across the product lifecycle. In this role, you will provide hands-on statistical expertise across the full product lifecycle, from early analytical method development through commercial manufacturing, ensuring compliance with ICH, FDA, and EMA guidance.
Essential Duties & Key Responsibilities
Design and execute comparability assessments for process changes, site transfers, scale- up/scale-down activities, and reference standard qualification, utilizing equivalence testing, quality range methods, and mixed-effects models to establish pre-specified acceptance criteria.
Develop and apply tolerance interval methodologies (parametric, non-parametric, and distribution-free approaches) to establish specifications, in-process control limits, and shelf- life/stability ranges across the product lifecycle.
Conduct Bland-Altman analysis and method-agreement/method-transfer evaluations to assess bias, limits of agreement, and comparability between analytical platforms, instruments, and laboratories.
Provide statistical support for analytical method validation and verification, including accuracy, precision, linearity, range, and robustness studies, with particular expertise in handling non- normal and skewed data through transformation strategies and non-parametric methods.
Author and review statistical sections of validation protocols, reports, and summary statistics packages suitable for regulatory submissions (BLA/MAA/NDA, CTD Module 3) and responses to health authority queries.
Develop, validate, and maintain statistical code and templates (R, SAS, JMP, Python) to ensure consistency, traceability, and reproducibility of analyses; stay current with ICH, FDA, and EMA guidance on comparability, analytical procedures, and statistical methods.
Collaborate with Analytical Development, Process Development, QC, and Regulatory Affairs to design fit-for-purpose experimental designs (DOE), sampling plans, and risk assessments while communicating statistical concepts clearly to non-specialist stakeholders.
Experience & Education
B.S., M.S., or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or a related quantitative field (or equivalent experience).
6+ years (B.S.), 3+ years (M.S.), or 1+ years (Ph.D.) of relevant industry experience applying statistics within a CMC, analytical development, or QC environment in biotech/pharma.
Demonstrated hands-on experience with comparability assessment methodologies for biologics or small molecules, tolerance interval construction (parametric and non-parametric), and Bland- Altman/method-comparison techniques.
Demonstrated experience providing statistical support for analytical method validation, including strategies for non-normal/non-Gaussian data, robust statistics, and bootstrapping methods.
Proficiency in a statistical programming language (JMP preferred; R, SAS, Minitab, or Python also relevant).
Working knowledge of relevant ICH Q2(R2), Q14, FDA, and EMA guidance related to analytical procedures, comparability, and specification setting.
Strong written and verbal communication skills with ability to explain statistical reasoning to cross-functional, non-statistical audiences.
Excellent attention to detail and ability to manage multiple concurrent projects in a fast-paced, highly regulated environment.
$100,000 - $160,000 a year
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Engineer, Manufacturing Sciences & Technology (MSAT) (3rd Shift)
Orca Bio · Sacramento, CA
Pay
$85k–105k
Setting
On-site
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
Engineer I, MSAT, works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. The Engineer I works on well-defined problems with clear scope and known troubleshooting paths, typically under guidance from more senior engineers or a manager.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Statistician, CMC (Chemistry, Manufacturing, and Controls)
Orca Bio · Menlo Park, CA
Pay
$100k–160k
Setting
On-site
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: We are seeking a skilled Statistician to join our CMC organization and provide statistical leadership across analytical method development, validation, comparability, and product characterization activities. The successful candidate will partner closely with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data (including non-normal distributions common in biologics assays), and translate results into clear, regulatory-defensible conclusions that support process and product decisions across the product lifecycle. In this role, you will provide hands-on statistical expertise across the full product lifecycle, from early analytical method development through commercial manufacturing, ensuring compliance with ICH, FDA, and EMA guidance.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Specialist, Facilities
Orca Bio · Sacramento, CA
Pay
$70k–90k
Setting
On-site
Specialist, Facilities
Sacramento, CAOperations – Facilities /Regular, Full-Time Employee /On-Site
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More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Specialist, Facilities is responsible for facilities, utilities and production and laboratory assets across multiple production sites producing clinical and commercial drug products. This role involves providing technical expertise for asset operation and troubleshooting, and utilization of a Computerized Maintenance Management System (CMMS) to manage asset data, asset labelling, asset status, and to coordinate and execute preventative and corrective maintenance, calibration and certification activities to ensure compliant and reliable operations to support production requirements to meet customer needs. They will also be responsible for managing and executing various projects in support of facility and utility system operations.
Physical Demands
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Work Conditions
Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
Job duties and responsibilities include:
Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
Track and report on equipment downtime, failure trends and develop corrective actions to prevent recurrence
Planning, scheduling and coordinating onsite and offsite preventative and corrective maintenance, calibration and certification activities to be completed by service providers
Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS
Ensure that facilities, utilities, production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards
Collaboration with peers in the continuous improvement of equipment standards, practices, specifications, procedures, qualifications and business processes
Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems
Execution of facility preventative and corrective maintenance tasks, small projects and continuous improvements
Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans
Other duties as assigned
Education & Experience Requirements:
Bachelor’s degree in Engineering, Life Sciences, Facility Management or equivalent technical experience
4 years of experience in GMP manufacturing facility, including equipment operation and troubleshooting, and facilities and asset maintenance execution in a GMP manufacturing facility
Experience in analyzing, managing, and reporting reliability metrics, and managing assets and maintenance activities using a CMMS system
Experience coordinating onsite and offsite maintenance, calibration and certification activities completed by service providers
Experience in managing and executing facility and utility projects including repairs, improvements and new installations.
Personal Qualities & Physical Demands:
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Willing to support sites after-hours on an as needed or on-call basis
Strong interpersonal skills and ability to communicate effectively
Strong problem-solving and critical thinking skills to support making decisions in a timely manner, and desire to improve upon established processes
Ability to gown and work in clean room areas
Ability to work in a collaborative manner, independently and as part of a team
Ability to work in a fast-paced start-up environment while following documented procedures and instructions.
Ability to work for extended periods of time at a computer
Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking
$70,000 - $90,000 a year
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
APPLY FOR THIS JOB
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