- Aequor (Seattle, WA)
- …including process development, analytical development, quality, and regulatory , to support project objectives. Develop and maintain detailed CMC project ... Job Description: Position: Technical Project Manager Location: Seattle WA Top...and collaboration across all involved teams. Ensure compliance with regulatory requirements and industry standards in all CMC… more
- Axelon Services Corporation (Seattle, WA)
- …including process development, analytical development, quality, and regulatory , to support project objectives. - Develop and maintain detailed CMC project ... Pay Ranges :$80 $89 Job Description: Technical Project Manager Location: Seattle WA Top...collaboration across all involved teams. - Ensure compliance with regulatory requirements and industry standards in all CMC… more
- Aequor (Thousand Oaks, CA)
- …for product manufacturing and quality programs throughout product lifecycle. Title: Regulatory Project Coordinator (RPC)Job Description: o Assist Regional ... a mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division ... organization of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late… more
- Cynet Systems Inc. (Summit, NJ)
- Competencies and Experiences: 5+ years of experience in GxP project management. 5+ years of experience in CAR T / Cell Therapy or Biologics. Understanding of GMP and ... FDA regulatory requirements correlating to biologics. Bachelors/Masters degree in Life...Bachelors/Masters degree in Life Sciences or technical field required. Project Management Professional (PMP) certification. Proficiency with related software… more
- System One (Warren, NJ)
- Job Title: Regulatory Project Manager CMC Location: Warren NJ (Hybrid) Compensation: $80 W2 Type: Contract Responsibilities Primary Responsibilities: + ... analytical development, quality, and regulatory , to support project objectives. + Develop and maintain detailed CMC... project objectives. + Develop and maintain detailed CMC project plans, including resource allocation, risk… more
- BeiGene (Emeryville, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . . Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs for Chemistry Manufacturing & Controls ( CMC ) works with ... and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal to RA CMC . Qualifications +… more
- BeiGene (Hopewell, NJ)
- …internal and external to CMC . This role will directly support Project Management, Technology Transfer, Regulatory Filings/Inspections. This position plays a ... **General Description:** This is an individual position for CMC and Project management of initial... CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives… more
- Charles River Laboratories (Wilmington, MA)
- …help you build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. ... mapping resource across projects. In this role, the Senior CMC Project Manager is the...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- Ascendis Pharma (Palo Alto, CA)
- …strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and clinical) collaboration with other project team members. + ... to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global… more
- BeiGene (San Mateo, CA)
- **General Description:** Sr. Manager /Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about us:** At ... + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation...representative or team lead). + Represent functional area on CMC project teams by communicating activities from… more
- ManpowerGroup (Groton, CT)
- **Job description for a REMOTE Pharmaceutical Project Manager for a fortune 100 client.** The Pharmaceutical Sciences Project Manager provides project ... drive decision making and outcomes at the interfaces of pharmaceutical / CMC technical development, project management, and budgeting. + Leads cross-functional… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description We are currently hiring a Project Manager Stability Optimization to join an exciting project ... Type II) have been prepared and submitted by RA CMC team + The reduced testing based on primary...Regulatory Affairs preferred + In-depth knowledge of global regulatory requirements for stability studies + Project … more
- System One (Summit, NJ)
- Job Title: Senior Project Manager Location: Summit, NJ Hours/Schedule: M-F (normal working hours) Type: Contract Overview Leading pharmaceutical company looking ... for an experienced Project Manager . Ideal candidates should have 5+...Therapy or Biologics + Understanding of GMP and FDA regulatory requirements correlating to biologics + Bachelors/Masters degree in… more
- Merck (Boston, MA)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... supplies. + Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Merck (West Point, PA)
- …and the operational/executional arms within the business. The Protocol Clinical Supplies Project Manager (Protocol CSPM) serves as the primary protocol-level GCS ... (as the GCS Planning protocol representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …optimization, and supervision of other manufacturing activities at CMOs. + Work within the CMC group and with internal and external project teams for timely ... and respect in all we do, create and deliver. As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** **Senior Manager , Formulation… more
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