Directeur principal, CMC/Sr. Director, CMC
Allucent
Director, Cmc
Chez Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Director, CMC to join our A-team (hybrid*/remote) in Canada. As a Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products.
As the Director, CMC, you will:
- Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
- Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
- Prepare product development plans from early development through Phase 4.
- Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
- Perform other scientist related duties, as needed.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Directeur principal, CMC/Sr. Director, CMC in United States vacancy
$170k - $275k
...cancers and immune-mediated inflammatory diseases. We are currently seeking a highly motivated, creative CMC formulation professional at associate director or director level to join our CMC team in San Diego. This candidate will report to the Executive Director and...SeniorKumquat Biosciences Inc
San Diego, CA9 hours ago- ...In this role the selected candidate will lead a team of MS&T professionals by providing strategic and operational leadership for the CMC execution and lifecycle management radiopharmaceutical drug products. You will be the primary interface between Manufacturing Operations...SeniorWork at office2 days per week3 days per week
Convergent Therapeutics, Inc.
Boston, MA5 days ago - ...Job Description Job Description Sr. Director/Director of Process Chemistry CMC (Small Molecules) Boston/New Jersey/Hybrid/Remote Overview We are exclusively partnered with a well-funded, clinical stage biopharmaceutical organization focused on advancing...SeniorRemote work
$152.7k - $218.13k
...Principal Scientist, CMC Analytical Development Remote Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical... ...pharmaceutics. Relationships: This position will report to the Director, Analytical Development, CMC or VP, Analytical Science and...PrincipalWork at officeRemote workFlexible hoursAkero Therapeutics
United States21 hours ago$170k
...Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry,...PrincipalTemporary workMonday to FridayFlexible hoursImmunityBio
Summit, NJ5 days ago- ...expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our... ...biotechs to mid-to-large size pharmaceutical companies. The Principal Consultant, Regulatory Affairs CMC will primarily be...PrincipalTemporary work
Opus Regulatory
Miami, FL10 days ago $160.5k - $305k
...Director Regulatory Affairs for Chemistry, Manufacturing and Controls Post Approval Change Dossier Management (CMC PAC DM) AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical...Temporary workWork at officeImmediate startRemote workMonday to FridayAbbVie
Great Lakes, IL3 days ago$150k - $200k
...Position: Business Development Manager/Director DP&C (Discovery, Preclinical & CMC) Location: Home based - San Francisco Bay Area Salary: $150,000 to $200,000 Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies...Contract workTemporary workImmediate startRemote workWork from homeWorldwideFlexible hoursPharmaron Beijing Co. Ltd.
New York, NY2 days ago- ...Senior Director, Regulatory CMC – CAR T Cell Therapy Kite, as part of Gilead, is dedicated to developing treatments and making advances in cancer therapies. The Senior Director, Regulatory CMC – CAR T Cell Therapy provides global leadership and strategic direction...Senior
Kite Pharma
Santa Monica, CA4 days ago - ...The organization is seeking a Senior Manager or Associate Director, CMC to lead and execute end-to-end Chemistry, Manufacturing & Controls... ...discipline (Pharmaceutical Sciences strongly preferred) w/ 6-8+ years (Sr. Manager) / 8-10+ years (AD) of experience in CMC, with a focus...Senior
- ...processes, and technology to drive strategic outcomes within the CMC Operations organization. The Senior Manager will be responsible... ...implementing innovative solutions. This role will report to the Director of CMC Operations. RESPONSIBILITIES This role will drive...SeniorWork at office
Aktis Oncology
Boston, MA6 hours ago - ...Physical Therapist Sr. - CMC - Gatesville - Full-Time Gatesville, Texas, United States Therapy Services UTMB Health Requisition # 2503639 The mission of Correctional Managed Care is to address the healthcare needs of underserved patient populations within...SeniorFull timeFor contractorsWork experience placementWork at officeLocal area
UTMB Health
Gatesville, TX5 days ago $141.5k - $268.5k
...Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have...Temporary workWork at officeImmediate startRemote workMonday to FridayAbbVie
Great Lakes, IL5 hours ago$157.59k - $203.94k
...Senior Manager, CMC Regulatory Affairs for Biologics At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve...SeniorWork experience placementGILEAD
San Mateo, CA3 days ago$156k - $316.5k
...multiple viewpoints. This is personal and we approach every challenge with radical care. Position Description The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products...SeniorFull timeWork at officeFlexible hours3 days per weekGenetix Biotherapeutics
Somerville, MA5 days ago$194k - $199k
...Site at one of our physical locations: Palo Alto, CA, Princeton, NJ, Miami, FL Overview of Role: The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high-quality global regulatory filings. This role will provide...Work at officeSummit Therapeutics
Palo Alto, CA5 days ago$180k - $210.5k
...This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation... ...Health Canada and ICH) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work...Remote workVaxcyte
San Carlos, CA4 days ago$159k - $195k
...communities. Learn more at and follow us on X, LinkedIn and Facebook. Role Summary: The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage...Local areaDyne Therapeutics Inc
Waltham, MA5 days ago$145k - $207k
...Associate Director, CMC Regulatory Cambridge, MA The Opportunity: As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs...Relay Therapeutics
Cambridge, MA5 days ago$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentWork at officeWork from homeModerna
Norwood, MA3 days ago- ...A leading biotechnology company is seeking an Associate Director for Regulatory Affairs, CMC to manage global regulatory strategies for development and lifecycle programs. The role involves interfacing with the FDA and producing CMC submissions. Ideal candidates will...SeniorRemote work
BeiGene
New York, NY2 days ago $285k - $320k
...Sr. Director, Regulatory Affairs San Francisco - 1800 Owens Mavericks Wanted When was the last time you achieved the impossible?... ...clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post-approval...SeniorWork at officeRemote workFlexible hoursBridgeBio
United States5 hours ago$144.4k - $195.4k
...Overview: The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC... ...enable efficient global submissions. This position reports to the Director of Regulatory Affairs CMC, or equivalent. This position is...SeniorFull timeTemporary workLocal areaFlexible hoursAlnylam
Cambridge, MA9 hours ago$200k
.... * Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control...Temporary workMonday to FridayFlexible hoursImmunityBio
Summit, NJ9 hours ago$130.8k - $209.4k
...background in stability data interpretation, statistical analysis, and shelf-life assessment. Experience working in cross-functional CMC teams within a matrixed development or commercial environment. Familiarity with ICH stability guidance and global regulatory...SeniorPermanent employmentFull timeWork at officeWorldwideModerna
Norwood, MA1 day ago- ...Associate Director CMC Company Description: Revelation Biosciences, Inc. is a clinical-stage biotech company dedicated to restoring immune balance by targeting inflammation through its proprietary Gemini formulation. The company is advancing a diverse pipeline of...Contract work
Revelation Biosciences Inc.
San Diego, CA4 days ago $135k - $160k
...to treat both rare and large market indications. We are currently seeking a highly motivated and technically strong Manager/Sr. Manager, CMC Product Management - Upstream to join our growing organization. This role will support the development and execution of...SeniorContract workWork at officeWork from homeRay Therapeutics, Inc.
Berkeley, CA5 days ago$117k - $171.6k
...life better for people around the world. Position Brand Description: This role is responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the development and implementation of an integrated technical plan for commercially...Full timeFlexible hoursEli Lilly
Indianapolis, IN5 days ago- ...Associate Director-Quality Assurance (QA-CMC) Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support...Contract workFor contractorsFlexible hours2 days per week1 day per week
Clinical Dynamix
Jersey City, NJ3 days ago - ...Skills: ~3 years of experience supporting Regulatory Affairs and/or CMC functions in the Biotechnology industry. ~ Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development. ~ Understanding...Senior
CodeForce
Seattle, WA5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Directeur principal, CMC/Sr. Director, CMC. Be the first to apply!
Related searches
- director of culinary United States
- children's ministry director United States
- youth director United States
- director consumer insights United States
- director of community outreach United States
- pathology director United States
- director it pmo United States
- nuclear director United States
- director of revenue integrity United States
- industrial director United States