Analytical Development Principal Scientist - CMC/IND-BLA
$120.8k - $224.3kF. Hoffmann-La Roche AG
F. Hoffmann-La Roche AG is seeking a Technical Development Principle Scientist for the Analytical Development Department in South San Francisco, California. The role involves serving as the analytical expert in a multi-disciplinary CMC team, contributing to multiple clinical therapeutics. The ideal candidate will possess a Ph.D. or equivalent experience, and expertise in analytical techniques such as HPLC and mass spectrometry. The salary range is $120,800 – $224,300 based on qualifications, with additional benefits including relocation assistance and bonuses. #J-18808-Ljbffr F. Hoffmann-La Roche AG
- A leading biopharmaceutical company in South San Francisco seeks a Technical Development Principle Scientist in the Analytical Development Department. The ideal candidate holds a Ph.D. and has solid analytical chemistry knowledge, including HPLC, mass spectrometry, and...Suggested
$120.8k - $224.3k
...Genentech!In Pharma Technical Development (PTD), we actively... ...it does.Our global Analytical Development and... ...and systems that enable CMC development of biologic... ...Development Principle Scientist position is available... ...successful regulatory filings (IND, BLA). The successful...SuggestedFull timeLocal areaFlexible hours$124.3k - $230.9k
...a highly motivated Senior Scientist or Principal Scientist with a strong record... ...our Synthetic Molecule Analytical Chemistry (SMAC) group. The... ...discovery through clinical development. Responsibilities Design, develop... ...systems, exposure to CMC, regulatory submissions, or...PrincipalLocal areaRelocation package$124.3k - $230.9k
...a highly motivated Senior Scientist or Principal Scientist with a strong record... ...our Synthetic Molecule Analytical Chemistry (SMAC) group. This... ...discovery through clinical development. The Scientist will play a... ..., and eventually lead in a CMC/cross functional environment...PrincipalLocal areaRelocation package$120.8k - $224.3k
Job Overview A Technical Development Principle Scientist is available in the Analytical Development Department of Pharma Technical... ...expert in a multi‑disciplinary CMC team and will contribute to the... ...successful regulatory filings (IND, BLA). Engage with internal and external...SuggestedLocal areaRelocation package$150k - $170k
...biotechnology company pioneering the development of allogeneic chimeric... ...with an emphasis on CMC knowledge and the ability to... ...Development, Manufacturing, Quality, Analytical Development, Supply Chain, Clinical... ...of regulatory filings (e.g., IND, BLA, CMC supplements) in...Work at officeLocal areaRemote work- ...comAbout the OpportunityOur client is seeking an experienced and highly motivated Small Molecule CMC Principal / Director to join a growing regulatory and product development consulting team. This role is focused on Chemistry, Manufacturing and Controls (CMC) strategy...PrincipalFlexible hours
- Genentech's Data, Digital, and Analytics (DDA) team is seeking a Principal Data Scientist to lead enterprise AI/ML initiatives in Commercial, Marketing, and... ...into rigorous analytical roadmaps and guide the development of scalable, production-grade solutions. The role...Principal
$260k - $295k
...and is approaching Phase 3 development. Our second clinical asset,... ...Manufacturing, and Controls (CMC) to be responsible for the development... ...Operations (Process/Analytical/Formulation Development,... ...submitting high quality CTA/IND and BLA/MAA filings for biologics Strong...Full timeWork at officeLocal area2 days per week$155k - $180k
...biotechnology company pioneering the development of allogeneic chimeric... ...Therapeutics is seeking Principal Scientist, Cell Starting Material -... ...regulatory documents (e.g., IND/BLA sections), and scientific... ...cross-functionally with R&D, Analytical Sciences, MSAT, Quality,...PrincipalFull timeLocal area$155k - $180k
...company pioneering the development of allogeneic... ...individual for the role of Principal Scientist, Drug Product Process... ...characterization and BLA readiness for allogeneic... ...Quality, Regulatory, Analytical Sciences, and... ...Module 3 DP sections (IND and BLA).Contribute to...PrincipalFull timeLocal area$175k - $205k
...to the Executive Director, CMC Regulatory Affairs, the Senior... ...activities associated with IND/CTA development and maintenance for support... ...planning for future MAA/NDA/BLA(s). This role requires an independent... ...., manufacturing processes, analytical methods, specifications,...Temporary workCasual workLocal areaWorldwideFlexible hours- ...Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and... ...across Tech Ops to align CMC with development and commercialization plans. The candidate will oversee high‑quality CTA/IND and BLA/MAA filings for biologics, manage the CMC...
- Position Overview Principal Research Scientist, Analytical Chemistry - South San Francisco, CA. This role requires onsite presence four days per week... ...Expertise in physicochemical analysis, analytical method development/validation, and CRO management. Experience in small...PrincipalShift work
$195.67k - $253.22k
...a critical role in the discovery and development of life-changing scientific innovations... ...for generations to come. As an Principal Scientist, Analytical Lifecycle Management , you will serve... ...Chemistry, Manufacturing, and Controls (CMC) teams. This role is accountable for...PrincipalFull timeContract workFor contractorsLocal area$200k - $240k
...desire to work on novel ideas. As a Principal Scientist, Potency, you will report to the Sr.... ...Head of Molecular and Potency Method Development. You will either lead or support the... ...Guidance Document to develop robust analytical methods for characterizing intermediates...PrincipalTemporary workWork at officeImmediate startWeekend work$195.67k - $253.22k
...a critical role in the discovery and development of life-changing scientific innovations... ...for generations to come. As a Principal Scientist, Analytical Operations at Gilead you will act as... ...development programs in alignment with overall CMC and quality objectives.Serve as the...PrincipalFull timeContract workFor contractorsLocal area$159k - $207k
...the collaboration of leading scientists, industry experts, and... ...processes, as well as authoring IND/BLA sections to support our large... ...coordinate study execution, review analytical results, generate/review... ...cell line and cell culture development activities. Execute methods...PrincipalContract workWork experience placementLocal area$173.1k - $321.5k
...people we love.The Senior Principal Scientist serves as the scientific leader... ...that enable the successful development of cell therapy products.... ..., Clinical Development, CMC, Regulatory, and Computational... ...questions while ensuring analytical approaches remain fit-for-purpose...PrincipalFull timeLocal areaRelocation package$125k - $180k
...Clinical Development Scientist/Senior Clinical Development Scientist TenvieTherapeuticsis developing... ...in regulatory submissions (e.g., IND/CTA, briefing packages, responses to queries... ...in a fast‑paced environment Strong analytical and critical‑thinking skills; able to...Interim roleLocal areaRemote work$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations... ...opportunity to transform CMC product development into scalable process that... ...substance, drug product, and analytical subject matter experts;... ...of leading a CMC team through IND and NDA/MAA preferred. + Must...$162k - $196k
...focused on the discovery, development, and commercialization of targeted... ...an experienced Senior Scientist to join the Analytical Development and Quality... ...analytical development reports and IND/IMPD/NDA sections and... ...with 8+ years of industrial CMC experience Strong experience...Contract work$112k - $135k
Senior Scientist I Analytical Development Alumis Inc. is a precision medicines company with the mission to transform... ...these patients. The small molecule CMC team is seeking highly motivated Sr.... ...for regulatory submissions (IND, IMPD, and/or NDA) Ideal Candidate...$167k - $206k
...committed to the discovery, development, and commercialization of transformative... ...all aspects of discovery analytical work. The successful... ...level associates and/or scientists, including direct reports or... ...salary range for the role of Principal Research Scientist, Analytical...PrincipalContract workTemporary workWork at officeLocal areaWork from homeShift work$225k - $260k
...decision support through insights and analytics for new product planning, launch strategy... ...with senior leaders invested in your development, you'll tackle challenging problems and... ..., Zurich, Mumbai & Gurgaon. Associate Principal in the Analytics practice, you are a senior...PrincipalTemporary workImmediate startFlexible hours$144.9k - $269.1k
...OpportunityGenentech is seeking a top-tier Principal Scientist in Chemistry with a proven record of... ...of our project-based research and development staff, is responsible for:Developing... .... In addition, writing relevant CMC sections of INDs and participating in developing a...PrincipalFull timeLocal areaRelocation package$153.3k - $284.7k
...PositionThis role is in Early Development Biometrics (EDB), a core... ...partner across Biostatistics, Analytical Data Science, and Data Management... ...:The Early Development Principal Statistician is a critical partner... ...regulatory submissions, such as INDs, EMA scientific advice...PrincipalFull timeLocal areaRelocation package- ...experienced and driven scientist/engineer to lead late-... ...cell culture process development activities for clinical... ...and review relevant CMC documentation including... ...regulatory sections (e.g., BLA, IND amendments).... ...with MSAT, Downstream, Analytical Development, CMC management...PrincipalContract work
- Alumis Inc. in South San Francisco, CA, is hiring a Sr. Scientist I of Analytical Development to bolster our small molecule CMC group. You will support method development, validation, and transfer at CMOs/CTLs from preclinical through late-stage clinical development. The...
$155k - $180k
...biotechnology company pioneering the development of allogeneic chimeric antigen receptor... ...Allogene is seeking a highly motivated Principal Scientist to lead the Pilot Plant function... ...technical reports, regulatory documents (i.e. IND/BLA sections), and scientific publications...PrincipalFull timeInternshipLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Analytical Development Principal Scientist - CMC/IND-BLA. Be the first to apply!
- r&d engineer South San Francisco, CA
- research and development engineer South San Francisco, CA
- product development engineer South San Francisco, CA
- development engineer South San Francisco, CA
- product development scientist South San Francisco, CA
- r&d engineering technician South San Francisco, CA
- process development scientist South San Francisco, CA
- senior principal cloud computing engineer South San Francisco, CA
- principal South San Francisco, CA
- senior principal scientist South San Francisco, CA

