Senior CMC Operations Lead — External Development & CDMOs
Biogen, Inc.
Biogen, Inc. seeks a Senior Manager, CMC Operations to oversee external development and manufacturing from IND-enabling studies through Phase 2 across multiple programs. You will serve as the CMC Pharma interface to CDMOs and partner with R&D, Quality, Supply Chain, and Finance to ensure alignment with GMP operations. You will develop and manage integrated development and manufacturing plans, drive governance frameworks, and manage interdependencies and risks while ensuring cost, quality, and #J-18808-Ljbffr Biogen, Inc.
- Biogen in Cambridge, MA is seeking a Senior Manager, CMC Operations to lead external development and manufacturing activities from IND-enabling studies through Phase 2 across programs. You will coordinate CDMO partnerships, align with R&D, Quality, Supply Chain and Finance...Suggested
- Biogen is seeking a Senior Manager, CMC Operations to lead external development and manufacturing activities from IND through Phase 2. You will manage CDMO partnerships, coordinate with R&D, Quality, Supply Chain and Finance, and drive scalable external development models...Suggested
- Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions... ..., Medical Writing, Clinical Development, CMC, and Quality to ensure... ...improvement, and partnering with external providers. #J-18808-Ljbffr Parabilis...Senior
$167k - $300.7k
...Director of Digital Operations and Strategic... ...Management, the Director, CMC Digital Operations... ..., Operations, and external partners to enable... ...build trust with senior stakeholders, and... ...execution plans. Lead planning and... ...are pioneering the development of a new class of...SuggestedPermanent employmentWork at officeWork from homeShift work$195k - $330k
...building an industry-leading pipeline of oral small... ...make an impact:Lead the development and execution of global regulatory CMC strategies for... ...regulatory CMC guidance to senior leadership regarding health... ...oversight of CDMOs and other external manufacturing/testing...Senior$173k - $285.33k
...Do As a Director/Senior Director, CMC Drug Substance Development, you will be an... ...design, execute, and lead chemical process development... ...Select and Oversee External Partners : Screen,... ...safety, plant operations, and experience... ...overseeing global CDMOs across process research...Senior- Centessa Pharmaceuticals in the US seeks a Senior Director of Drug Product in CMC to lead nonclinical and clinical formulation development and manage CROs/CDMOs. This role supports Phase I-III programs, with travel to domestic and international vendors. The successful candidate...Senior
- What You’ll DoThe Senior Quality Assurance Specialist... ...oversight across CMC development, Quality Control, Analytical... ...and drug product operations, including external manufacturing partners and CDMOs.• Review and approve... ...inclusive of market-leading benefits to meet our...SeniorFull timeContract workImmediate start
$138k - $185k
About This Role: As the Senior Manager, CMC Operations, you will be an... ...within our Early Phase Development & Manufacturing team... ...will be overseeing external development and... ...Pharma interface to CDMOs, ensuring consistent... ...programs and CDMOs. Lead operational engagement...SeniorTemporary workLocal area$235k - $285k
...culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of a... ...teams - from early development through launch. This role... ...cross-functional teams, external partners, and regulatory... ...s technical strategy and operational plans are aligned with Elektrofi...SeniorTemporary workLocal area$210k - $320k
...committed to establishing the leading, fully integrated platform... ...motivated Sr. Director / Director of CMC, to lead our advancing... ...program moves through clinical development into commercial. This person... ...quantitation, cell-based assays.External CDMO alliance management...SeniorFull time- Senior Director, Operations Commercialization Lead (Cell Therapy) At AstraZeneca our mission is to create an inclusive and equitable environment, where people... ...company that focuses on the discovery, development and commercialisation of prescription medicines. Our...SeniorWorldwide
- Xenon Pharmaceuticals Inc. in Needham/Boston, MA seeks a Senior Manager, Trial Operations to lead Phase 3 trial delivery from start-up to closeout. Partners with Clinical Development, CMC, Regulatory Affairs and external vendors to drive strategy, risk management and high-...SeniorRemote job
$200k - $220k
Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at... ...career in science, clinical development, commercial strategy, and... ...work cross‑functionally to lead development and... ...relationships with internal and external stakeholders. Skills and...SeniorContract workWorldwideFlexible hours- Judo Bio in Cambridge, MA is seeking a Senior Scientist to lead injectable formulation development for siRNA programs, reporting to CMC leaders. You will drive DP... ...design, analytical characterization, and external scale-up with CDMOs. This role interfaces with internal...Senior
- ...Cambridge, MA, is seeking a Senior Scientist in Analytical... ...& Technology to lead method transfers and validations at external CDMOs. You will author and review... ...-stage cell therapy development. The role demands hands... ...Analytical Development, CMC, QA) and external labs...Senior
$195k - $330k
...focused on building an industry-leading pipeline of oral small... ...make an impact:Drive end-to-end CMC program management for mid to... ...programs, including timeline development, critical path identification,... ...Prior experience in working with CDMOs and CROs, technology transfer,...Senior$121k - $172k
...Your Role:You will lead and drive strategy... ...analytical method development and phase-... ...substance programs at CDMOs, directing method... ...programs.Provide senior-level review and approval... ...and reports at external laboratories, serving... ..., partnering with CMC, Quality Assurance...SeniorContract workShift work$144k - $176k
...pioneering the discovery and development of a new class of... ...against approved CMC Ops budgets and interface... ...project delivery, team operational efficiency and... ...in project management, leading cross‑functional teams... ...discrimination, or retaliation. Seniority level Mid‑Senior level...SeniorFull timeWork at office- ...highly organized and collaborative CMC Project Manager to support CMC development activities across our portfolio of... ...closely with CMC Technical Leads and cross-functional teams to drive... ...complex activities across internal and external stakeholders.Position Responsibilities...Work at office
$235k - $330k
...building an industry-leading pipeline of oral small... ...ll make an impact:The Senior Director of Early Phase Formulation Development will provide scientific... ...with Research, DMPK, and CMC functions to advance... ...; coordinate with external CROs and CDMOs to execute early formulation...Senior- ...Therapeutics is a leading biopharmaceutical... ...editing through the development of SyNTase™... ...Therapeutics, Inc., and R&D operations based in Boston,... ...research, CMC and clinical manufacturing... ...internal and external stakeholder management... ...program to Senior Management; ensures...SeniorRemote work
- Senior Scientist, CMC Analytical Development Join to apply for the Senior Scientist, CMC Analytical Development role at Mariana Oncology . Get AI-powered advice on this job and more exclusive features. Job Description We are seeking an experienced Senior Scientist, CMC...SeniorFull time
$145k - $161k
...Medicine is a leading biotechnology company... ...clinical development and regulatory... ...Position SummaryThe Senior Scientist /... ...activities to external contract development... ...organizations (CDMOs), including... ...and Controls (CMC) sections of regulatory... ...processes, TFF operations, and related...SeniorFull timeContract workTemporary work$136.8k - $179.6k
...emphasis on research and development. Our history includes... ...to translate external innovation into meaningful... ...Management & Execution Lead and manage active external... ...colleagues and engage senior stakeholders in a... ...Internet based system operated by the Department of Homeland...Senior$210k - $300k
...Biomedicines is seeking a Senior Director, Analytical Development to set the... ...direction and lead execution of... ...President, Technical Operations, this leader... ...comparability, external analytical operations... ...partner to CMC, Process Development... ...with CDMOs, contract testing...SeniorContract workShift work$115k - $165k
...Senior Project Manager Centessa is seeking a Senior Project Manager... ...project management and drug development experience to support one or... ...budget Manage select external vendors (timelines, budgets,... ...stage clinical, nonclinical, CMC development, and regulatory interactions...SeniorFull time$210k - $300k
...Opportunity OverviewAs the Senior Director, Analytical Development and Quality... ...supply.You will lead and develop a... ...while overseeing external partners, including CDMOs, CROs, and contract... ...of the Technical Operations leadership team,... ...laboratories.Regulatory & CMC...SeniorContract workWork at office$218.4k - $327.6k
Job DescriptionGeneral Summary:The Senior Director, Business Operations Lead is a senior role within the... ...processes. Contribute to the ongoing development of business operations processes,... ...experience supporting manufacturing, external manufacturing, CDMO management, or...SeniorFull timeContract workSummer workRemote workFlexible hours2 days per week$171.6k - $338.3k
...driven, end-to-end learning operations model that goes far beyond... ...seeking a highly driven Senior Manager to lead the growth and expansion of... ...business development activities for large-scale... ...within the last 5 years, in an external consulting environment3+ years...SeniorLocal areaVisa sponsorship
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