Location and Travel: role can support remote-based candidates. Travel expectations: up to 15%.
Key ResponsibilitiesCommercial & Medical Affairs Legal Support
Serve as key legal partner and SME to commercial and medical teamsProvide practical legal advice on pre-launch activities and launch strategy, including medical (e.g., MSL activities and programs), disease awareness, sales, marketing (brand messaging, activities and campaigns), marketing analytics, patient advocacy programs, advisory boards, incentive compensation for commercial personnel and other business activitiesCounsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub servicesAct as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies Training of applicable personnelOversee outside counsel; conduct and respond to diligence for financings, business development activities and the like as needed; and review other external corporate content such as press releasesCompliance Program Support
Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligationsPartner with Compliance to evolve the U.S. compliance program consistent with company size and scope and aligned with company valuesPartner with Compliance to coordinate training activities including legal and compliance responsibilities, ethics, policies and proceduresSupport development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codesQualification RequirementsJD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech preferred)Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes, and ability to stay current on evolving trends and enforcementExperience reviewing promotional and medical materialsAbility to interpret and apply healthcare laws to complex business plansExperience supporting product launch planning and cross functional review committees (experience building for first US launch preferred)Strong business partnering skills with ability to balance risk and business goalsExcellent communication skillsAbility to manage multiple priorities in a fast-paced environment; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demandsThe 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.
Read LessOrca Bio is seeking a Contract Research Associate to support the Analytical Development team. This lab-based role will contribute to the characterization, qualification, and validation of analytical methods used to support the development of cell therapy products. The successful candidate will perform hands-on laboratory studies, maintain accurate documentation, and collaborate with a multidisciplinary team to advance analytical method development and validation.
Key Responsibilities
Preferred Qualifications, but do not have to have all of them:
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.
Read LessWe 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.
Read LessWe 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.
Read LessPosition Summary:
The Specialist, IT & Manufacturing Systems Support is a hybrid role designed to ensure 24/7 operational continuity for our manufacturing facilities. This individual will serve as the frontline technical resource during night and weekend shifts, handling Level 1 and Level 2 IT helpdesk troubleshooting (such as Okta lockouts and basic system routing) while also being trained to execute electronic Batch Record (eBR) building and document updates within MasterControl.
We are looking for a technically savvy, detail-oriented individual who can follow strict protocols, troubleshoot system access issues, and escalate complex problems to the appropriate system administrators.
Essential Duties & Key Responsibilities:Provide Level 1 and Level 2 troubleshooting for critical manufacturing applications (e.g., TrakSYS, MasterControl, and enterprise systems) during graveyard and weekend shifts.Resolve urgent issues that are impacting the manufacturing process such as access issues, password lockouts, workflow restarts, and label printing issues.Triage, document, and escalate complex hardware or software issues to corresponding Tier 3 IT or system owners when immediate resolution is not possible.Support weekend and off-shift activities as part of a 24/7 coverage model, with specific shift availability required for weekends (10:00 PM – 6:00 AM) and weekdays (6:00 PM – 6:00 AM).Act as an off-shift drafting and testing resource for electronic Batch Records (eBR), following explicit, structured directions to update step references and system parameters.Assist with basic, standardized tasks within the MasterControl Manufacturing Excellence (MX) and Quality Excellence (QX) modules.Serve as off-shift MasterControl Administration and Document Control owner to ensure production documentation moves seamlessly through the pipeline. E.g., process MC tickets including account creation, termination and role assignments.Support data entry and system routing tasks per established Good Manufacturing Practices (GMP) and data integrity guidelines.Occasionally provide on-site hardware or system troubleshooting at the manufacturing facility during weekend shifts if needed, though routine work can be managed remotely.Required Qualifications:Technical Savviness: 2+ years of experience in an IT Helpdesk, Technical Support, or Systems Support role (Level 1/2 troubleshooting).Shift Flexibility: Ability to work non-traditional hours, specifically overnight shifts (10:00 PM - 6:00 AM / 6:00 PM - 6:00 AM) and weekends (Saturday/Sunday).Process-Driven Mindset: Exceptional attention to detail with the ability to follow rigorous, step-by-step technical instructions for resolving technical issues and updating system configuration and eBRs.Systems Familiarity: Experience with identity management/SSO tools and IT ticketing systems.Label Printing: Experience troubleshooting label printing software (e.g., Bartender) and hardware (e.g., Brady, Zebra) issues.GMP Awareness: Prior experience working within a regulated GMP manufacturing environment is highly preferred, but a strong understanding of compliance, data integrity, and 21 CFR Part 11 requirements is required.MasterControl/MES Experience: Prior experience with MasterControl (MX/QX modules) or MES system (e.g. TrakSYS) is a plus, but not required. Comprehensive training on basic MasterControl administration and eBR writing will be provided.This role will also come with shift differential pay.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.
Read Less Position Summary:
The Manager, Quality Control is responsible for providing oversight for the GMP testing of cell therapy products and critical intermediates. Additionally, this role will support regulatory and internal inspections and oversee key aspects of quality control workflows, including leading investigations of out‑of‑specification results and addressing environmental monitoring excursions. This position will work cross-functionally to ensure that products are sampled and tested under applicable regulations and guidelines of current Good Manufacturing Practices (cGMPs). There are regular interactions with internal manufacturing and with service providers. The successful candidate shall be an experienced manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.Physical DemandsProduction 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 ConditionsMany 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.Key Responsibilities:Lead GMP testing operations and meet critical business goals.Oversee day-to-day operations associated with raw material testing, in-process testing, and release and stability testing of clinical and commercial cell therapy products. Perform data reviews and release completed test results. Provide oversight for microbiology testing and environmental monitoring.Plan, forecast, and allocate laboratory resources and equipment to ensure efficient execution of quality control testing, including managing staffing levels, scheduling workflows, maintaining instrument availability, and coordinating procurement and maintenance to meet project timelines and regulatory requirements.Provide supervision of QC associates; assess, plan and manage resource allocations for QC; define training requirements and manage training status of QC staff as required to execute activities of the function; schedule QC and EM projects and schedules. Hire, mentor and develop QC personnel, including QC Supervisors.Contribute to the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, comply with cGMP requirements and meet commercial stage standards. Review and approve test methods and procedures associated with QC activitiesProvide leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product.Collaborate with analytical development on updates and validation of test methods. Define method trending metrics and perform method trendingIdentify and mitigate risks in QC labs that could negatively impact the safety, identity, strength purity or quality of the product.Define requirements and lead equipment qualification, maintenance and calibration practices and manage instrument capacityParticipate in outsourcing decisions and oversight of contract testing organizations for specific tests as neededContribute and lead direct interactions with Regulatory agencies (audits, etc.).Responsible for generating environmental monitoring reports and managing the environmental monitoring program for the site.Required Experience7+ years of relevant experience in quality control, or a related field such as analytical development or quality assurance and a BS or BA; or 5+ years of relevant experience and a MA/MS/MBA. At least 2 years of experience managing personnel.Knowledge of global regulatory requirements, guidance and best practices for biopharmaceuticals and advanced therapies such as cell and gene therapies.Experience and knowledge of environmental monitoring programs, including ISO 14644 and EU Annex 1.Experience with the application of cGMPs, USP/NF, FDA guidelines, EU regulations and ICH guidelines in the pharmaceutical industry.Experience with flow cytometry and cell therapies is strongly preferred.Experience with standard biologic safety testing, e.g. endotoxin and sterility per USP <71>.Experience with implementation and use of LIMS and other quality management system software; experience with implementing, improving and ensuring robust data integrity approaches.Experience in preparing for and participating in quality and regulatory audits. Experience with risk management and qualification of raw materials and vendors/contract service providers.Ability to identify and elevate issues and support solutions.Excellent oral and written communications skills and a collegial personality. Thrives and succeeds in a team-oriented environment.Ability to work in a fast-paced environment, to multitask and manage multiple projects.Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement. 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.
Read LessSummary:
In this Sacramento-based role, reporting into our VP/Head of CMC, you will lead the design, development, validation, and lifecycle management of analytical methods supporting cell therapy programs. This role will provide strategic and technical leadership with a strong emphasis on advanced flow cytometry, method validation, and cell-based assays. The ideal candidate brings deep expertise in cell therapy analytics, a proven track record in regulatory submissions, and demonstrated success in building and leading high-performing scientific teams.
ResponsibilitiesLeadership & Strategy
Provide scientific and operational leadership for the Analytical Development function supporting cell therapy programs.Build, mentor, and lead a team of scientists specializing in flow cytometry, cell-based assays, and analytical characterization.Define and execute analytical strategies aligned with program, regulatory, and commercialization timelines.Collaborate cross-functionally with Process Development, Manufacturing, Regulatory Affairs, QC, and Clinical teams.Develop methods related to raw material testing and microbial release tests.Flow Cytometry & Cell Therapy Expertise
Lead the development, optimization, and qualification of multiparametric flow cytometry assays for cell identity, purity, potency, and phenotypic characterization.Establish standardized panels, controls, and gating strategies for complex cell therapy products (e.g., CAR-T, TCR-T, stem cell-derived therapies).Drive innovation in high-dimensional cytometry and data analysis approaches.Analytical Method Development & Validation
Oversee development, qualification, transfer, and ICH-compliant validation of analytical methods.Ensure assays meet regulatory expectations for precision, accuracy, specificity, robustness, and stability.Lead comparability studies, reference standard programs, and method lifecycle management.Establish an efficient strategy for method validation and transfer.Regulatory & Compliance
Author and review analytical sections of IND, BLA, and other regulatory submissions.Serve as a technical subject matter expert during regulatory agency interactions.Ensure compliance with cGMP, GLP, and regulatory guidelines.Operational Excellence
Drive continuous improvement in assay robustness, throughput, and scalability.Manage budgets, timelines, and resource allocation across multiple programs.Oversee technology transfer to Quality Control laboratories.Required QualificationsEducation & Experience
Ph.D. in Immunology, Cell Biology, Analytical Chemistry, or related field requiredMinimum 10+ years of industry experience in biotech or pharma8+ years’ experience in experience in cell therapy analytical development (e.g., CAR-T, gene-modified cells, stem cells)MSc degree acceptable with 15+ years of relevant experienceTechnical Expertise
Deep expertise in flow cytometry assay development (multicolor panels, intracellular staining, rare cell detection, functional assays)Strong background in analytical method validation (ICH Q2 and regulatory expectations)Experience with cell-based potency assaysFamiliarity with advanced cytometry technologies (e.g., spectral cytometry, CyTOF) is a plusStrong understanding of CMC development for biologics and cell therapiesLeadership Skills
Proven experience leading and developing high-performing teamsStrong project management and cross-functional leadership skillsAbility to influence stakeholders at all organizational levelsStrategic thinking and scientific rigorStrong communication and presentation skillsResults-driven with a focus on quality and complianceAbility to manage complexity in a fast-paced environmentPreferred QualificationsExperience supporting late-stage clinical programs or commercial productsPrior experience interacting with FDA/EMA regulatory agenciesExperience in data analysis tools (FlowJo or equivalent)Knowledge of automation and digital data systems in analytical labsThe 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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