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
$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$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$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- ...Squibb is seeking a Manufacturing Associate I to support routine Cell Therapy manufacturing operations in Bothell, WA. You will work within... ..., batch records and training to ensure quality, safety and regulatory compliance. The role requires 0-1 years of cGMP manufacturing...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$21.14 - $24.14 per hour
...Description We are seeking a Manufacturing Associate to support cell therapy production in a regulated biopharmaceutical manufacturing... ...; ~ Experience in regulated environments, including regulatory inspections; ~ Familiarity with Syncade MES, Oracle, ETQ, BMRAM...RegulatoryHourly payContract workFor contractorsVisa sponsorshipRotating shift$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- Scorpion Therapeutics seeks a Global Regulatory Lead to shape and execute global regulatory strategies across oncology programs. You will... ..., cross-functional collaboration. You will drive regulatory submissions (INDs, BLAs, NDAs), interact with FDA and EMA, and stay...Regulatory
$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$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$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$94k - $129.25k
...enabling life‑changing therapies for patients around the... ...Manager, Lot Disposition to lead the review, collation,... ...to the team, supports regulatory inspection readiness,... ...Lead QA support for the review... ...genetically engineered cells therapies. Across our global...RegulatoryFull timeContract workMonday to Friday$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$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- ...improving patients' lives. Our lead drug candidates, lasofoxifene... ...5, are novel, small molecule therapies with the potential to address... ...is seeking a Director, Regulatory Affairs, Strategy to lead global... ...module ownership, content plan, submission timeline — through submission...Regulatory
- ...Immunome seeks a Principal Statistical Programmer to lead SAS programming efforts for clinical trial data analysis and regulatory submissions. This senior individual contributor role involves developing CDISC-compliant datasets, analysis outputs, and documentation while...PrincipalRegulatory
$171k - $273k
...Clinical Operations, Image Guided Therapy DevicesThe Director of Clinical Operations... ...progress against goals while leading complex negotiations with regulatory bodies, sites, and vendors and... ...coordination, ethics committee and IRB submissions, site initiation, patient...RegulatoryFull timeContract workWork at officeLocal areaImmediate startWork visaRelocation package3 days per week$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- ...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
- ...independence Develop and implement individualized occupational therapy treatment plans based on patient needs and goals Document... ..., and discharge planning in accordance with facility and regulatory standards Collaborate with interdisciplinary team members to...RegulatoryWeekly payFull timeContract workImmediate start
$100 - $150 per hour
...Sciences environment. What the Role Offers - Principal Project Manager - Manufacturing... ...the COO, their staff and executive team. Leads multidisciplinary teams in predicting and... ...development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA),...PrincipalRegulatoryHourly payContract workWork at officeLocal areaWorldwide$130k - $160k
...Description SystImmune is a leading and well-funded clinical-... ...success. We are seeking a Principal Scientist to provide... ...from early feasibility through regulatory submission and commercialization readiness... ...with Regulatory Affairs and QA to support CDx regulatory strategy...PrincipalRegulatoryFull time$124.32k - $170.94k
...life by enabling life‑changing therapies for patients around the globe... .... In this role, you will lead the development and implementation... ...guidance to support regulatory compliance and operational excellence... ..., and genetically engineered cells therapies. Across our global...RegulatoryFull timeContract workFor contractorsLocal areaFlexible hours$175.1k - $240k
...class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio... ...Compliance and Audit Program. This role leads supplier audit management, vendor... ...based, inspection-ready, and aligned with regulatory requirements and Immunome’s Quality Management...RegulatoryContract workAfternoon shift
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