Associate Director, CMC Drug Substance — API Development
Xenon Pharmaceuticals
Xenon Pharmaceuticals is seeking an Associate Director, CMC, Drug Substance to join the CMC Drug Substance team in Boston, MA. The role focuses on overseeing API development and manufacturing programs with CDMOs to support clinical trials and regulatory submissions. The position reports to the Senior Director, CMC, Drug Substance and may consider exceptional remote candidates. Travel up to 15% may be required as part of program oversight and vendor management. #J-18808-Ljbffr Xenon Pharmaceuticals
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Associate Director, CMC Drug Substance — API Development in Needham Heights, MA vacancy
- ...biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-... ...the Role: _ We are seeking an Associate Director, CMC, Drug Substance to join our CMC Drug Substance... ...pharmaceutical ingredients (APIs) for deployment in pre-pivotal...SuggestedContract workTemporary workRemote workFlexible hours
$143k - $233k
Associate Director/Director, CMC Regulatory Cambridge, MA As part of the Pharmaceutical Development team, this position will play a key role in regulatory... ...company transforming the drug discovery process with... ...to: Alcohol or other substance use disorder (not currently...SuggestedContract workFor contractorsFor subcontractorWork at office$145k - $207k
...Associate Director role leading late-stage small molecule drug substance development and manufacturing at global CMO/CRO sites. Responsible for process development, regulatory compliance, technology transfer, and commercialization support for early and late-stage pipeline...Suggested$99.5k - $156.42k
Senior Drug Substance (API) Technical Operations Manager Location: Lexington, MA | Salary: $99,500.00 - $156,420.00 | 3 weeks ago. Education... ...experience in the small molecule DS (API) manufacturing or development environment Experience with lifecycle management for...SuggestedContract work$161.5k - $218.5k
Overview The Associate Director, Downstream, Emerging Modalities, is expected... ...leadership for downstream development of novel modalities, with primary... ...transition by leading CMC team as necessary for the assigned... ...working on cross-functional drug development teams....SuggestedFull timeTemporary workLocal areaFlexible hours$142.5k - $256.5k
The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...regulatory compliance support for the development of global products. The... ...a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits...Permanent employmentWork at officeLocal areaWork from home$143k - $203k
...Role You will be the lead and an integral part of Relay’s drug product development team supporting development programs. You will be responsible... ..., review and ensure completion of drug product sections of CMC-regulatory submission documents (IND, IMPD, NDA, PIP, iPSP,...$166.4k - $249.6k
...Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational... ...Leads regulatory colleagues in development of global CMC regulatory... ...Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices,...Summer workRemote workFlexible hours2 days per week$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development... ...-based therapeutics, including siRNA, antibody drug conjugates, and next-generation delivery systems. This...Full timeTemporary workWork at officeLocal areaFlexible hours- ...and operational regulatory CMC leadership to support clinical... ...of assigned projects for development and/or commercial products.... ...activities. Responsibilities: The Associate Director, Regulatory Affairs CMC will... ...of Investigational New Drug Applications/Amendments (INDs...
- Associate Director/Director, Business Development, CMC Services Associate Director/Director, Business Development, CMC Services... ...pre-clinical and clinical drug development. Frontage operates out... ...analytical testing services—including API and product release, stability studies...Full timeContract workWork experience placementWork at officeRemote work
$170k - $210k
...alternative application process. Associate Director, Formulation Development Cambridge, MA, US 12 days... ...studies, including API form characterization and... ...scalable and cost-effective drug product manufacturing... ...assessments Author assigned CMC sections to support regulatory...$159k - $219k
About This Role The Associate Director, Small Molecule Analytical Development will provide scientific and people leadership... ...setting, and contributing to CMC regulatory submissions. The position... ...activities for small molecule drug substance and drug product programs, including...Contract workTemporary workLocal area$159k - $219k
About This Role The Associate Director, Antisense Oligonucleotide (ASO) Analytical Development will provide scientific and people leadership... ...activities supporting ASO drug substance and drug product programs.... ...while partnering across CMC functions and with external organizations...Contract workTemporary workLocal area- ...Biogen seeks an Associate Director to lead analytical development for small molecule programs from early clinical stages... ..., and lifecycle management for drug substance and product programs Develop... ...Development on cross-functional CMC teams, contributing to strategy,...Contract work
Biogen
Cambridge, MA16 days ago - Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview Founded over a decade ago,CRISPR Therapeuticsis a leading... ...to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-...Contract workRemote work
- ...bringing deep expertise to the development and delivery of positron... ...most. Job purpose The Associate Medical Director provides study-level medical... ...Pharmacovigilance, Regulatory, Quality, CMC and other functions to... ...in clinical research or drug development is desirable....
- ...Associate Director role overseeing outsourced manufacturing of oligonucleotide drug substances for clinical and pre-commercial programs. The position requires hands-on expertise in cGMP synthesis and purification, regulatory filing support, and cross-functional collaboration...Contract work
$160k - $190k
Senior Manager/Associate Director, Quality Control / Analytical Development At Merida Biosciences, we are pioneering true precision... ...experienced, and collaborative CMC team. In this role you will... ..., validation, and transfer for drug substance (DS) and drug product (DP) in‑...Full timeContract workLocal area$212k - $333.19k
...seeking an experienced and visionary Senior Director Small Molecule CMC Advisor to lead the analytical development strategy for our small molecule this high-impact... ...analytical development strategies for drug substances (API) and drug products. Talent Mentorship & Growth...Minimum wageFull timeLocal areaRemote work- ...focused on the formulation, development, and commercialization of innovative... ...robust product pipeline of drug delivery solutions developed... .... Position Summary : The Associate Director, Validation provides... ...authority interactions, audits, and CMC discussions and will...
$142.5k - $256.5k
The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...regulatory compliance support for the development of global products, with focus on... ...a smoke-free, alcohol-free, and drug-free work environment. Pay &...Permanent employmentWork at officeWork from home$180k - $205k
...therapeutics company advancing the development of novel neuropsychiatric... ...Therapeutics is hiring an Associate Director, Program Management to lead... ..., Technical Operations (CMC), and Nonclinical Development... ...Development. Working knowledge of the drug discovery, development, and...Work at office$115k - $170k
...Description of Role Centessa is seeking a Associate Director, Project Management - Orexin Development Programs . This individual will... ...both project management and drug development experience to manage... ...-stage clinical, nonclinical, CMC development, and regulatory interactions...Full timeFor contractors- ...neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics... ...operations. About the Role: We are seeking an Associate Director, Patient Marketing , to join our team. The Associate...Temporary workWork at officeRemote work2 days per week
$154.4k - $242.55k
Associate Director - MSAT Synthetic Molecule API OBJECTIVES: The Associate Director, MSAT Synthetic Molecule API... ...manufacturing of commercial Drug Substance. The focus for this position is... ...knowledge of phase appropriate CMC development throughout the drug development...Minimum wageFull timeContract workFor contractorsWork at officeLocal areaWorldwideNight shift$139k - $232k
.... Summary Of Role We are seeking an Associate Director, Technical & CMC Support (PET Quality Operations) to... ...oversight for technical transfers from development through commercial readiness,... ...that includes medical, prescription drug, dental, and vision coverage. Other...Contract workWork at officeLocal areaRemote work$142.17k - $213.26k
...Are you a visionary expert in clinical drug development, possessing the capabilities to drive... ...join us! We are currently seeking an Associate Director Clinical Scientist, Immunology Cell Therapy... ..., biostatistics, regulatory, safety, CMC, commercial operations). Experience...Hourly payTemporary work- ...Kymera Therapeutics seeks an Associate Director of Analytical Development to lead CMC analytical activities supporting clinical and commercial development... ...Responsibilities Develop and validate analytical methods for drug substance and product characterization Design and...Contract work
$159k - $219k
...Biogen seeks an Associate Director to lead analytical development for antisense oligonucleotide drug substances and products. The role combines scientific and people leadership, overseeing... ..., and team management within a matrixed CMC environment. Responsibilities Lead...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, CMC Drug Substance — API Development. Be the first to apply!
Related searches
- associate manager Needham Heights, MA
- associate director Needham Heights, MA
- service operations leadership development program Needham Heights, MA
- development producer Needham Heights, MA
- leadership development program Needham Heights, MA
- community development Needham Heights, MA
- vice president sales development Needham Heights, MA
- professional development program Needham Heights, MA
- training development Needham Heights, MA
- client development Needham Heights, MA