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Keywords: Associate Director, Regulatory CMC Compliance, Location: USA

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Associate Director, Global Program Management, Neuroscience TAU

. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director... of Sr. Manager and/or Associate Director level GPMs as well as contractors within the GPM function. May support Business...

Company: Takeda
Location: Cambridge, MA
Posted Date: 12 Feb 2025

Associate Director, Integration Engineer

treatment of NASH with compensated cirrhosis. Role Overview: Associate Director, Integration Engineer As the Associate... scalable, effective solutions. Regulatory Compliance and Documentation: Ensure all integration workflows adhere to regulatory...

Posted Date: 02 Feb 2025

Associate Director, Process Engineering

Job Title: Associate Director, Process Engineering Job Location: United States Job Location Type: Remote... from discovery to patients. Join our team as we transform the lives of others. Position Summary The Associate Director, Process...

Company: Lifelancer
Location: San Diego, CA
Posted Date: 01 Feb 2025
Salary: $138000 - 192000 per year

Associate Director/Director Non-Clinical Safety

Job Title: Associate Director/Director Non-Clinical Safety (Toxicology) Job Location: United States Job Location... of development programs Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program...

Company: Lifelancer
Location: Waltham, MA
Posted Date: 17 Jan 2025

Associate Director, Analytical Development

Development team in Boston, MA. As the Associate Director, you will play a central role in advancing transformative medicines... challenges. Compliance: Ensure adherence to cGMPs (current Good Manufacturing Practices) and Regulatory guidelines. Laboratory...

Location: Boston, MA
Posted Date: 16 Jan 2025

Associate Director, Analytical Science & Technology (Biologics/Cell & Gene Therapies)

. Additionally, the Associate Director will be accountable for authoring regulatory filings, defining strategies for follow-up...Job Description The Associate Director of Biologics, Cell, and Gene Therapy (BioCGT) holds a matrix leadership...

Location: Boston, MA
Posted Date: 11 Jan 2025

Analytical Sciences & Technology Associate Director

. Additionally, the Associate Director will be accountable for authoring regulatory filings, defining strategies for follow-up...Job Description The Associate Director of Potency, Biologics, Cell, and Gene Therapy (BioCGT) holds a matrix...

Location: Boston, MA
Posted Date: 11 Jan 2025

Associate Director, GMP Quality Assurance

of development, and are released in a timely manner. Collaborate with CMC, Clinical Supplies Management, Regulatory Affairs... with industry best practices and regulatory changes, and ensure the organization is prepared for compliance. Participate in risk...

Company: pmvpharma
Location: Princeton, NJ
Posted Date: 02 Mar 2025

Associate Director, External Supplier QA-GMP

Members, Pharmaceutical Technology, QA-GMP and QA RD functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical... best practices and will withstand regulatory inspections by regulatory authorities and regular audits. Drug Product Management...

Company: Daiichi Sankyo
Location: Basking Ridge, NJ
Posted Date: 01 Mar 2025

Associate Director/Scientific Leader – Sterile Drug Product Development

of the wider Medicine Development and Supply organization) is a highly experienced Chemistry, Manufacturing and Controls (CMC...-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC...

Company: GlaxoSmithKline
Location: Pennsylvania
Posted Date: 08 Feb 2025

Nursing Director of Care Management

, while maintaining compliance with clinical protocols and regulatory standards. The Director will lead a collaborative team... at . Department: ICE | CORE PA Central Access Department's Website: Summary of Job Duties: The Director of Care Management...

Location: USA
Posted Date: 27 Feb 2025

Manager, Manufacturing Technical Operations

mitigations and report closure. Reporting directly to the MTO Associate Director, the MTO Manager will be pivotal for maintaining... concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC...

Location: Boston, MA
Posted Date: 05 Mar 2025

Manager/Sr. Manager, Quality Assurance Operations

. This position reports to the Associate Director of Quality Operations, Pharmaceutical Packaging. Responsibilities Perform batch... and reports Support CMC activities, including reviewing and assisting with regulatory submissions Author, review, and update QA...

Company: BridgeBio
Location: California
Posted Date: 04 Mar 2025
Salary: $130000 - 190000 per year

Field Reimbursement Manager

all activities within defined regulatory and compliance standards. Achieve and maintain compliance with all applicable Medexus... Pharma policies and procedures, regulatory and legal requirements, and help to monitor compliance during cross functional...

Company: Medexus Pharma
Location: USA
Posted Date: 11 Feb 2025
Salary: $155000 - 195000 per year

Senior Scientist - Stability Testing, GMP

at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Reporting to the Associate Director, CMC QC... and Drug Product for clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs...

Posted Date: 25 Jan 2025

Manager, Supply Chain Planning

. Reporting directly to the Associate Director, Supply Chain Planning & Systems, this role requires a high degree of autonomy... to drive continuous improvement. Cross-Functional Collaboration & Compliance: Collaborate with internal teams...

Company: Precigen
Location: Germantown, MD
Posted Date: 18 Jan 2025