Remote Associate Director, CMC - Drug Substance
Xenon Pharmaceuticals Inc.
- Remote job
Xenon Pharmaceuticals Inc. is seeking an Associate Director, CMC, Drug Substance to lead API development and manufacturing programs. You will manage CDMOs, oversee tech transfers, and ensure compliance with cGMP and regulatory requirements for clinical and pivotal trials. The role reports to the Senior Director, CMC, Drug Substance and is based in Boston, MA with remote consideration for exceptional candidates. Travel up to 15% may be required. #J-18808-Ljbffr Xenon Pharmaceuticals Inc.
$172.3k - $217.9k
...biopharmaceutical company dedicated to drug discovery, clinical development, and... ...the Role: We are seeking an Associate Director, CMC, Drug Substance to join our CMC Drug Substance team.... ...of Boston, MA, USA. We will consider remote locations for exceptional candidates...Remote workFull timeContract workTemporary workFlexible hours- Sabin Foundation Europe is seeking a Manager, CMC Drug Substance to provide technical leadership across vaccine drug substance development, including process development, characterization, technology transfer, and GMP manufacturing. You will lead technology transfers,...Remote job
- ...Position Overview The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing... ...Authors Chemistry, Manufacturing, and Control (CMC) sections of regulatory filings; supports the CMC review...SuggestedFull timeShift work
$165k - $205k
The Associate Director of Drug Product Development supports the planning and execution... ..., quality systems, and CMC documentation to support... ...close collaboration with Drug Substance Manufacturing, Analytical... ...employee benefits under the Company’s benefit plans. #Remote...Remote workFull timeWork from homeFlexible hoursNight shiftAfternoon shiftEarly shift$165k - $200k
Description Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT At Merida Biosciences, we are pioneering true precision medicines for antibody... ...Head of Drug Substance . This individual will own the CMC execution strategy for a fusion protein drug substance...SuggestedLocal area$185k - $200k
...steps. Our partner is looking for a Associate Director of Regulatory Affairs, CMC based in United States. This... ...environment. The position is remote within the United States, with San... ...rigorous Module 3/CTD content covering drug substance, drug product, analytical...Remote workFull timeFlexible hours$160k - $240k
## Mfg Operations Associate Director - Biologics, Drug SubstanceApplylocations: Seattle, WAtime type: Full... ...technical execution of biologics drug substance manufacturing at external... ...designated as: 1. **Hybrid**: work remotely up to two days per week; **or select...Remote workSummer workFlexible hoursShift work2 days per week$162.5k - $227.5k
Associate Director, CMC Project Management Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical... ...management experience supporting drug development programs Proven experience... ...CMOs, suppliers, strategic alliances, and remote or global teams is preferred WHO WE ARE...Remote workFull timeFor contractorsWork at officeWork visa3 days per week$175k - $210k
...diseases, starting with the kidney. Position Summary:The Associate Director, Drug Substance Manufacturing - Upstream Process will report to the VP, Commercial... ..., and other recombinant therapeutics.Working with the CMC team and other key functions such as project management,...Contract workFor contractorsFlexible hours- Job Description:We are seeking a Director, CMC-Drug Substance to join our growing organization. Reporting to the VP, CMC & Program Management, and focused upon drug substance CMC activities, the Director’s primary responsibility will be to collaborate with our external...Full timeContract workTemporary workLocal areaMonday to FridayFlexible hoursShift work
$182.07k - $235.62k
...Responsibilities:The Associate Director, Strategic Sourcing &... ...Supplier Management, Sterile Drug Product and Biologics... ..., biologics drug substance and drug product, and... ...GFlex program allowing remote work up to 2 days per... ...team (PDM subteam and/or CMC) needs for the...Remote workFull timeContract workFor contractorsLocal area$150k - $195k
...Operations Location: San Diego, USA- Remote Be a part of a global team that... ...patients. Position Summary: The Associate Director, Technical Operations (Small Molecule CMC) will provide technical... ...lifecycle management of small molecule drug products. This individual will...Remote workContract workTemporary work- General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date: Tuesday, July... ...08-2026 Work Schedule: Full time Remote Work: In office Job: RI - R&D, Innovation... ..., response to queries, Orphan Drug Applications, and annual reports....Remote workPermanent employmentFull timeTemporary workWork at office
$193k - $246k
...point.insitro is seeking an (Associate) Director, Drug Product Operations to lead... ...working closely with other CMC roles, Regulatory, and... ...equally comfortable in drug substance, analytical, and supply chain... ...onsite for local candidates; remote candidates with willingness...Remote workWork at officeLocal areaHome officeFlexible hours3 days per week$110 - $120 per hour
...Description Job Description Job Title: Associate Director, CMC Technical Development The position... ...role drives CMC execution across drug substance and drug product development,... ...external partners. Comfort working in a remote, consulting-style role with a high degree...Remote workContract workTemporary workPart timeWork at officeDay shift- ...robust, expanding pipeline, with its lead drug candidate entering the clinic this year... ...and experienced Principal Scientist / Associate Director, CMC Formulation Development, to join our... ...Seattle, WA (On-site, hybrid or fully remote). Key Duties and Responsibilities: Advance...Remote work
$210k - $245k
...decision making.Summary:The Director for Drug Substance (DS) Commercialization of... ...activation, conjugation, and associated raw materials. This role... ...network, including Regulatory, CMC, Quality, Supply Chain,... ...changes to company policy): Remote Location: Remote; prefer Raleigh...Remote work- Travere Therapeutics in San Diego, with remote options, is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing at CDMOs, supporting late-stage development toward commercial readiness. The role collaborates...Remote job
- insitro is seeking an Associate Director, Drug Product Operations to lead DP strategy and execution for our early‑stage pipeline, spanning pre‑clinical through first‑in‑human studies. You will own formulation, DP process development, fill/finish, and CDMO partnerships...Remote job
$210k - $240k
...to patients by ensuring that CMC development, manufacturing, and... ...position reports to Senior Director, CMC Program Management and is... ...with functional leads (Drug Substance, Drug Product, and Analytical... ...anticipated salary range for Associate Director level candidates who...H1b$150k - $215k
...acne lesions. We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing. Position Overview:... ...Leadership Oversee outsourcing and management of drug substance and drug product development at Indomo’s CDMO — including...Remote workFull timeLocal area$159k - $207k
...responsible for organizing and managing CMC strategies, deliverables, and... ...technical leaders, Program Directors, and cross-functional project... ..., plans, and deliverables for drug candidates from the research,... ...at CROs/CMOs required Drug Substance and Drug Product GMP...Contract workLocal area$143k - $203k
...the lead and an integral part of Relay’s drug product development team supporting development... ...completion of drug product sections of CMC‑regulatory submission documents (IND,... ...but are not limited to: Alcohol or other substance use disorder (not currently using drugs...For contractorsFor subcontractor$159k - $207k
...Responsibilities: Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND... ...with technical leaders, Program Directors, and cross-functional teams to... ...at CROs/CMOs required. Drug Substance and Drug Product GMP experience...- Associate Director, Drug Safety and Pharmacovigilance Location: Alameda, CA Status: Full-Time POSITION... ...development experience in both drug substance and drug product, including... ...knowledge into the broader aspects of CMC development and lifecycle management....Full time
- Responsibilities: Define and execute the IT solutions roadmap for CMC digital transformation. Oversee implementation and lifecycle... ...and reduced error rates via digital tech transfer of Drug Substance/Drug Product/analytical methods and data. Enable creation, transformation...Flexible hours
$143k - $233k
Associate Director/Director, CMC Regulatory Cambridge, MA As part of the Pharmaceutical Development team, this... ...medicines company transforming the drug discovery process with the goal of... ...are not limited to: Alcohol or other substance use disorder (not currently using drugs...Contract workFor contractorsFor subcontractorWork at office$178k - $200k
Associate Director, CMC, Program Management Cambridge, MA Amylyx has an audacious mission to usher in a new era for treating diseases with high... ...Location and Conditions At Amylyx, we proudly support remote work opportunities within the United States. However, due to...Remote workLocal area$225k - $270k
...POSITION SUMMARY: The Drug Safety Physician in Drug Safety & Pharmacovigilance department... ...and Thursday. Employees designated as remote are expected to work onsite during normal... ...of potential medicinal product risks, associated with signal detection. Ensure appropriateness...Remote workFull timeLocal areaFlexible hours- ...Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview Founded over a decade ago,CRISPR Therapeuticsis a leading... ...in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions...Remote workContract work
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