Principal QA Lead — Cell Therapy & Regulatory Submissions
Lyell Immunopharma
Lyell Immunopharma is seeking a Principal, Quality Assurance to lead QA oversight across the cell therapy product lifecycle. Based in Bothell, WA, you will partner with Manufacturing, MSAT, Process Development and Regulatory to support process validation, tech transfer and regulatory submissions. You will serve as Quality SME for IND/BLA coordination, author and review CMC sections, and ensure inspection readiness with a focus on continuous improvement and robust validation strategies. #J-18808-Ljbffr Lyell Immunopharma
$150k - $185k
Using living cells to treat - and sometimes... ...with cell therapies. However, these... .... The Principal, Quality Assurance... ...Development, and Regulatory to support process... ...regulatory submission support for submission... ...readiness. Lead cross-... ...capability to oversee QA operations and...PrincipalRegulatoryWork at officeLocal areaShift work$186.12k - $211.8k
...best-in-class targeted cancer therapies. We are advancing an... ...targets.Position OverviewThe Principal Scientist, Clinical Pharmacology... ...analysis, report preparation and regulatory document preparation.... ...pharmacometric reports and regulatory submissions and performing quality...PrincipalRegulatory$170k - $196.23k
...best-in-class targeted cancer therapies. We are advancing an... ...experienced and collaborative Principal Scientist, Analytical Development... ...analytical documents for regulatory submissions. ResponsibilitiesDevelop... ...and regulatory requirements. Lead investigations of method...PrincipalRegulatoryContract workAfternoon shift$155.9k - $190.22k
...best-in-class targeted cancer therapies. We are advancing an... ...Position OverviewThe Senior / Principal Scientist, Formulation and... ...Drug Product Development will lead formulation and drug... ...on late-stage development, regulatory submissions, process validation readiness...PrincipalRegulatory$154.23k - $177.73k
...class targeted cancer therapies. We are advancing an innovative... ...Position OverviewAs a Principal Statistical Programmer... ...role will support the submission-readiness of study... ...standards, applicable regulatory guidance, and internal... ...of identified issues. Lead technical initiatives...PrincipalRegulatory- Role Lead QC compliance for cell therapy manufacturing, specializing in deviations, investigations, CAPAs, change controls, and process improvements... ...cross-functional collaboration compliance with global regulatory standards representing QC in inspections WorkSetup not...Regulatory
$169.59k - $206.23k
...best-in-class targeted cancer therapies. We are advancing an... ...are seeking an experienced Principal Scientist, Chemical Development... ...person will play a key role in leading challenging drug candidate process... ...sections of various regulatory documents (IND, IMPD, NDA, briefing...PrincipalRegulatoryAfternoon shift$212.15k - $240k
...class targeted cancer therapies. We are advancing an innovative... .... This role will lead day-to-day activities... ...to align with regulatory updates and business needs... ...documentation related to QA operations. Regulatory... ...to support regulatory submissions, including providing...Regulatory$259.08k - $396.2k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...targets.Position OverviewAs the Global Regulatory Lead at Immunome, you will be the key decision... ...compliance with local regulations for global submissions.Stakeholder CommunicationCommunicate...RegulatoryLocal areaFlexible hours$130k - $160k
...SystImmune is a leading and well-funded clinical-stage biopharmaceutical... .... We are seeking a Principal Scientist to provide... ...from early feasibility through regulatory submission and commercialization... ...with Regulatory Affairs and QA to support CDx regulatory strategy...PrincipalRegulatoryFull time- Immunome, Inc. in Bothell, Washington, seeks a Senior / Principal Clinical Scientist in Clinical Development to lead design, execution, and interpretation of oncology... .... You will collaborate with clinical operations, regulatory affairs, and R&D to advance multiple candidates....PrincipalRegulatory
$177.4k - $238.96k
...best-in-class targeted cancer therapies. We are advancing an... ...Associate Director / Director, Regulatory Affairs CMC, responsible for... ...adherence to accelerated regulatory submission schedules. Reporting into the... ...Serve as the regulatory CMC lead on cross-functional teams, providing...RegulatoryFlexible hours$149.93k - $203.96k
...developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics,... ...deliver high-quality data that informs decision-making and regulatory submissions. Reporting to the Executive Director, Head of ADME, the Scientist...Regulatory$287.89k - $394.94k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing... ...Support preparation of regulatory submissions and health authority interactions. Contribute...Regulatory$175k - $199.58k
...best-in-class targeted cancer therapies. We are advancing an... ...budget, and in compliance with regulatory requirements and corporate objectives... ...Project Delivery Lead cross-functional facilitation... ...decisions.Support regulatory submissions (INDs, NDAs, BLAs) and health...Regulatory$94k - $129.25k
...enabling life‑changing therapies for patients around... ...lifecycle. Responsibilities Lead CMC development,... ...Development, Analytical, QC, QA, MSAT, Supply Chain,... ...PPQ readiness, regulatory submissions, and commercialization... ...genetically engineered cell therapies. We are a collaborative...RegulatoryFull timeContract work$288.03k - $353.64k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...strategic Senior Director, Pharmacometrics to lead model-informed drug development... ...decisions, dose selection and optimization, regulatory submissions, and product labeling. The successful...Regulatory$108.65k - $131.66k
...optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the... ...access our complete Equal Employment Opportunity statement. Regulatory Disclosure for California Residents If you live in or expect...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$260.97k - $309.34k
...best-in-class targeted cancer therapies. We are advancing an... ...budget, and in compliance with regulatory requirements and corporate objectives... ...development programs and/or lead key projects.... ...decisions. Support regulatory submissions (INDs, NDAs, BLAs) and health...Regulatory$175.55k - $200.97k
...best-in-class targeted cancer therapies. We are advancing an... .... This role also ensures the submission-readiness of study data packages... ...CDISC standards, applicable regulatory guidance, and internal standards... ...Contribute to and, where appropriate, lead departmental initiatives,...RegulatoryFor contractors$200.09k - $295k
...best-in-class targeted cancer therapies. We are advancing an... ...objectives are met. The Director leads and develops a team of external... ...leadership, Legal, Finance, Regulatory, and other key stakeholders to... ...planning. Support regulatory submission activities and regulatory inspections...RegulatoryAfternoon shift$179.61k - $211.64k
...best-in-class targeted cancer therapies. We are advancing an... ...portfolio. This role will primarily lead the execution of HEOR studies... ...clinical development, medical, regulatory, and market access priorities... ...and pricing strategy to submission-ready models adapted for HTA...RegulatoryWork experience placementImmediate startFlexible hours$260k - $293.98k
...best-in-class targeted cancer therapies. We are advancing an innovative... ...Practice (GVP), and global regulatory requirements (FDA, EMA, ICH, etc... ...Strategy Execute Development QA objectives and priorities established... ...establish audit priorities. Lead or oversee internal and...Regulatory$270k - $290k
...amyotrophic lateral sclerosis (ALS). Our lead programs, lasofoxifene and brelgometon, are novel small-molecule therapies with the potential to address devastating... ...and analysis through data interpretation, regulatory submissions, and health authority interactions....RegulatoryTemporary workInterim roleImmediate startFlexible hours$120.2k - $141.96k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...work as well as ensuring scientific and regulatory compliance. Act as the primary contact... ...analysis plans, reports and regulatory submissions (such as IBs, CTDs, INDs, BLAs). QualificationsA...Regulatory$221.2k - $387.1k
...security from blocker to enabler.Role As Principal Engineer for AI Security Governance, you... ...individual-contributor role: you will lead through technical authority, architecture... ...solutionsWorking knowledge of compliance and regulatory standards, and experience in Agile...PrincipalRegulatoryPermanent employmentWork at officeImmediate startRemote workFlexible hoursShift work$123k - $170k
...values drive our collective progress and impact.The Principal Mechanical Engineer is responsible for leading the mechanical design of complex mechanical... ...other departments to ensure projects conform to all regulatory and quality requirements• Create part and assembly...PrincipalRegulatoryTemporary workWorldwideFlexible hours$90k - $140k
...SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located... .... The Senior Scientist in the Cell Science Department is responsible for the... ...Procedures (SOPs) and technical reports for regulatory filings. Prepare process transfer...RegulatoryFull timeShift workWeekend work- ...Principal Civil Engineer Build Projects. Lead Strategy. Drive Growth. At LDC, Inc., you will lead land development... ...delivery, and ensuring compliance with regulatory requirements throughout all... ...efficient project execution Ensure QA/QC procedures are implemented and...PrincipalRegulatoryContract workWork at officeLocal area
$155.4k - $261.1k
Principal Storage Engineer Position Summary We are seeking a highly skilled and experienced... ...standards, mentor senior engineers, and lead strategic initiatives that enhance... ...compliance with enterprise security, audit, and regulatory requirements. Collaborate with...PrincipalRegulatoryTemporary workWork at officeLocal areaRelocation
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