Senior Manager, Late-Phase Drug Substance PD/MSAT
Merida Biosciences
Merida Biosciences is seeking a Sr. Manager / Associate Director to lead late-phase drug substance PD/MSAT, interfacing with a CDMO and the CMC team to drive strategy and execution. You will guide process characterization, PPQ development, and regulatory deliverables in collaboration with upstream and downstream SMEs. The role requires a Ph.D. or MS with extensive experience in biologics, DoE and multivariate analysis, and hands-on bioreactor leadership. #J-18808-Ljbffr Merida Biosciences
$165k - $200k
...Description Job Description Description: Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT At Merida Biosciences, we are pioneering true... ...range for this role upfront: typically for the Senior Manager/Associate Director we target $165,000 to...SeniorLocal area$122k - $174k
...chemist who enjoys working on drug substance projects? Do you love working... ...you will be responsible for managing the chemical development and... ...in our pipeline spanning from late research through clinical trials... ...will define and implement phase-appropriate control strategies...SeniorContract work$135k - $215k
...tenacity to overcome barriers, together.Opportunity OverviewAs a Senior Manager, Drug Substance you will provide oversight of project teams at CDMO’s... ...and APIs for GLP studies as well as early and late-stage GMP clinical studies.Collaborate with CDMOs to address...SeniorContract workWork at office$140k - $165k
...optimization and life‑cycle management of Sobi’s clinical and... ...SAT team holds the senior scientific and... ...) for Small Molecules Drug Substance Manufacturing. Process... ...products. Lead and execute MSAT projects such as... ...clinical and commercial phase. Be aware of external...SeniorContract workTemporary work- Vertex is seeking an experienced scientist to help develop analytical control strategies for small molecule drug substances across clinical and commercial‑enabling phases. You will collaborate with CMC functions and external vendors to design and execute studies that inform...Senior
$122k - $174k
...be an integral part of Relay’s drug product development team... ...be responsible for developing phase-appropriate oral drug product... ...studies.Your Role:You will lead and manage formulation development activities... ...will coordinate with drug substance, DMPK, toxicology and analytical...Senior$202.94k - $274.57k
...while transforming your career.Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)What you... ...transfer, and lifecycle management of synthetic and hybrid drug... ...processes for our early- and late-phase clinical and commercial portfolios...SeniorFull timeContract workFlexible hours- ...Cambridge, MA is seeking a seasoned process chemist to lead drug substance development, scale-up, and external manufacturing collaborations across programs from late research through clinical trials. You will manage tech transfer to global CRO/CDMOs, design scalable routes...Senior
- Amgen is seeking a Process Development Senior Scientist to lead development, characterization, scale-up, and support of drug substance processes for late-stage programs. You will work with cell culture and purification experts to advance a diverse pipeline, contributing...Senior
- ...Quality Control activities supporting clinical and commercial drug substance (DS) and drug product (DP) programs in accordance with ICH... ...strong background in small molecules, spanning early to late clinical phases through registration, PPQ, and commercial stages. #J-1880...Senior
- ...Pharmaceuticals Inc. is seeking an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for clinical and commercial drug substances and products. The role spans early to late clinical phases through PPQ and registration, requiring oversight...SeniorWork at office
- Ultragenyx Gene Therapy in Bedford, MA is seeking a Quality Assurance Drug Substance Specialist to oversee QA activities at the new gene therapy... ..., Engineering, Validation, QC, Quality Systems, and MSAT to approve procedures, batch records, and change controls. #J...Senior
- Orna Therapeutics, Inc., a Lilly subsidiary based in Watertown, MA, seeks a Senior Advisor to lead downstream process development and scale-up for circular RNA drug substances. The role emphasizes design of experiments, process optimization, and cross-functional transfer...Senior
- Servier Massachusetts is seeking an Assoc Director, Oral Solid Drug Product within MSAT to provide technical stewardship across Oncology and... ...and CMOs to ensure manufacturing readiness and lifecycle management. Hybrid work in Boston with occasional travel up to 20%. Requires...Senior
$145.5k - $218.3k
...Science and Technology (MSAT) Process team for... ...aseptic and/or low bioburden drug products to... ...for production of drug substance/intermediates for manufacturing... ...operational aspects of late phase to commercial GMP aseptically... ...recruiter or hiring manager, or contact Talent Acquisition...Full timeContract workSummer workRemote workFlexible hours2 days per week$258k - $281.7k
...company dedicated to drug discovery,... ...depression and pain. Our Phase 3 azetukalner... ...channel modulator in late-stage clinical development... ...We are seeking a Senior Director, Quality... ...of Program Management, CMC, Regulatory Affairs... ...stages (Drug Substance, Drug Product, Finished...SeniorTemporary workWork at officeRemote work2 days per week$200k - $260k
...lead program, a PD-1 x VEGF... ...novel antibody-drug conjugates. By... ...seeking a Director/Senior Director, GMP Quality... ...programs into late-stage... ...cell bank, drug substance, drug product,... ...selection and management, process validation... ...strategies, including phase -appropriate...SeniorContract workTemporary workFlexible hours$250k - $285k
...its lead program, a PD-1 x VEGF bispecific... ...as novel antibody-drug conjugates. By leveraging... ...activities through late-stage process... ...effective program management and external CDMO oversight... ...strategy for early phase development, tech... ...manufacturing and MSAT operations...SeniorContract workTemporary workFlexible hours- ...Molecule DS Project Lead within the Drug Substance Portfolio Leadership (DSPL)... ...DS and PV leadership for late-stage synthetic molecule... ...strategy and execution. This senior matrix role develops DSL/PVL... ...CDMOs, and advances QbD, risk management, and governance across regions...Senior
$173k - $285.33k
...and developing novel small molecule drugs for indications in virology and immunology... ...What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will be an integral... ...commercialization. Lead and Manage Team Execution : Lead a group of chemists...Senior$128k - $142k
Alkermes in Boston is seeking an experienced Quality Assurance professional to provide onsite support for Phase I/II manufacturing activities. The ideal candidate will ensure compliance with FDA/EU cGMP requirements and will be responsible for analytical lifecycle oversight...Senior$250k - $280k
Senior Director, Biologics Drug Substance Development and Manufacturing About this position About Us Korsana Biosciences is a private biopharmaceutical... ...requires strategic vision and hands‑on experience managing early‑stage biotech programs in a dynamic, fast‑paced...SeniorContract workWork experience placement$210k - $300k
...together.Opportunity OverviewAs the Senior Director, Analytical... ...commercialization and lifecycle management. This role is accountable for defining and executing phase-appropriate analytical... ...development and QC activities across drug substance and drug product. As a key...SeniorContract workWork at office$141k - $228.8k
...need them, improve the understanding and management of disease, and give back to our... ...Summary We are seeking an exceptional Senior Advisor to join our team. The candidate... ...technical development and scale‑up of drug substance processes. The ideal candidate will have...SeniorFull timeFlexible hours$122k - $174k
...be an integral part of Relay’s drug product development team... ...validationYour Role:You will manage requisite formulation and process... ...supply.You will partner with drug substance and analytical development... ...understanding of the fundamentals / phase appropriate formulation and...SeniorImmediate start- Amylyx Pharmaceuticals is seeking a Senior Director, Clinical Pharmacology... ...from first-in-human through Phase 3. Reporting to the VP, this role... ...regulatory submissions and robust drug development. The successful candidate will lead deep PK/PD, exposure-response analyses,...Senior
- Ultragenyx Pharmaceutical in Bedford, MA seeks a Quality Assurance Drug Substance (DS) Specialist to oversee QA activities for a gene therapy... ...site. You will review batch records, perform deviations management, and collaborate across Manufacturing, Engineering, QC, and Quality...Senior
$115.5k - $167.5k
...looking for a highly motivated Senior Manager/Associate Director External... ..., you’ll establish a new phase appropriate manufacturing specialist... ...viral vector and ancillary drug substance manufacturing across a... ...including technology transfers, late‑stage clinical/commercial...SeniorContract workLocal area$279.41k - $308.6k
...biopharmaceutical company dedicated to drug discovery, clinical... ...and pain. Our Phase 3 azetukalner program... ...channel modulator in late‑stage clinical development... ...seeking an experienced Senior Director, US Patient... ...Agency, Budget & Vendor Management Select, manage, and lead...SeniorTemporary workWork at officeRemote work2 days per week$185k - $235k
...Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP... ...qualification of vendors and ensure compliant vendor management and regular assessment/audits. May... ...to emerging challengesUnderstanding of drug development and program management preferred...Senior
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