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 Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT At Merida Biosciences, we are pioneering true precision medicines for antibody-driven... ...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
...overcome barriers, together. Opportunity Overview As a Senior Manager, Drug Substance you will provide oversight of project teams at CDMO’s... ...intermediates and APIs for GLP studies as well as early and late-stage GMP clinical studies. Collaborate with CDMOs to address...SeniorContract workWork at office- Zealand Pharma seeks a Global Head of Drug Substance - Senior Director in Boston to build and lead a new peptide process development function from... ..., scale‑up, and technology transfer to CMOs, guiding Phase 1-3 strategies and ensuring scalable, cost‑effective processes...Senior
- ...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
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$137k - $215.27k
...analytics, and digital innovation to accelerate drug development and improve health outcomes... ..., faster decisions. Role Overview The Senior Manager, Biostatistics provides strategic and... ...experience across multiple development phases or therapeutic areas (Neuroscience...SeniorWorldwide$155k - $225k
...statistics to join our team. The Senior Manager/Associate Director,... ...multiple clinical studies from Phase 1 through Phase 3. Provide accurate... ...clinical studies, mid- and late-stage efficacy trials, safety... ...minimal of 2 years of relevant drug development experience in...Senior- ...The Position Senior Principal Statistician A healthier... ...methods across PDD, PD and the broader Roche Pharma... ...analytical partners in end-to-end drug development, Biostatistics... ...Experience with multiple phases of drug development (early and/or late stage) Experience in...SeniorLocal area
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$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$145.5k - $218.3k
...Manufacturing Science and Technology (MSAT) Process team for... ...process technologies (drug product and drug substance) including simulations, filter... ...operational aspects of late phase to commercial GMP aseptically... ...the recruiter or hiring manager, or contact Talent...Full timeContract workSummer workRemote workFlexible hours2 days per week- Title: Senior Scientist, Drug Product Development & External Manufacturing Location... ...studies to select Phase appropriate DP Presentation... ...characterization of critical drug substance (DS) and drug product (DP) properties... ...Ability to effectively manage time and prioritize tasks...SeniorLocal area
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- ...Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-... ...expertise in multiple therapeutic areas or development phases. Strong inter-personal and people management skills. Strong collaborative skills and ability to work...Senior
$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- Amylyx Pharmaceuticals, Inc. is seeking a Senior Director, Clinical Pharmacology to provide strategic leadership from early to late-stage trials. Lead PK/PD, exposure-response analyses, and modeling across programs, partnering with Clinical Development, Biometrics, Regulatory...Senior
- Zai Lab in Cambridge, MA seeks a Senior Medical Director to lead late-stage clinical development in Oncology, including pivotal Phase III trials and regulatory submissions. The role includes medical oversight as Medical Monitor, cross-functional collaboration, and external...Senior
- ...Your expertise in analytical techniques and experience in the pharmaceutical industry will be critical for defining strategies and managing projects at contract facilities. A supportive work environment and comprehensive benefits are part of our commitment to your...SeniorContract work
- Generate is seeking a Senior Director, Scientific Project Lead, Cardio... ...development strategy, and manage and develop scientific talent.... ...considerations such as biomarkers and PK/PD. Demonstrated success... ...pioneering the AI revolution in drug design and development. We are...SeniorShift work
- Role Senior Manufacturing Associate I in mRNA and LNP drug substance operations, responsible for executing GMP manufacturing processes for clinical and commercial vaccines. Core responsibilities aseptic processing, formulation, filling, dispensing, and documentation compliance...SeniorWork at office
$140k - $158k
...marketing events, budget and contract management, asset governance, and marketing... ...compliance. We plan to hire the Senior Manager, Marketing Operations... ...not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for...SeniorContract workFor contractorsFor subcontractorH1bWork at officeLocal areaRemote work- Skedda is a leading global workplace management platform serving over 7,000... ...About the role Skedda is hiring a Senior Demand Generation Manager to own... ...not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder,...SeniorContract workFor contractorsFor subcontractorWork at office2 days per week
$210k - $300k
...Opportunity Overview As the Senior Director, Analytical... ...commercialization and lifecycle management. This role is accountable for defining and executing phase-appropriate analytical control... ...development and QC activities across drug substance and drug product. As a key...SeniorContract workWork at office$102.3k - $209.5k
...and leads the startup and commissioning phases of major data center projects. Identifies... ...colocation providers. Selects, negotiates, and manages contracts with external vendors,... ...immunization/occupational health mandates, and/or drug testing requirements. Range and...SeniorContract workTemporary workFor contractorsFlexible hoursShift work$165.61k - $253.02k
...Responsibilities This position will offer you the opportunity to manage project team(s) consisting of engineers, designers, estimators,... ...the Electrical team lead in the coordination of detailed design phases for all aspects of electrical engineering work. Lead efforts...SeniorHourly payContract workWork at officeLocal areaFlexible hours3 days per week- Northstar Project & Real Estate Services in Cambridge, MA seeks a Senior Project Manager with an engineering/architecture/ construction management... ...ensure constructability and compliance through all project phases. A minimum of 8+ years CRE PM experience and strong...Senior
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