CMC Analytical Project Manager
Reporting Line: Director, Chemistry & Manufacturing
Purpose of Position
The CMC Analytical Project Manager is responsible for the implementation and oversight of CMC projects and activities with a particular focus on development and validation strategies for Drug Substance and Drug Product analytical methods to support third party cGMP manufacturing and Regulatory submissions. In addition, the position supports preclinical and clinical bioanalytical method development and validation strategies. The individual will be required to develop and manage project plans and budgets to achieve core objectives.
Roles & Responsibilities:
Oversight and coordination of Drug Substance and Drug Product manufacturing and testing activities conducted at CMO’s
- Working with management and interdepartmental teams to construct project plans and timelines
- Oversight on creation and justification of specifications for Drug Substance and Drug Product; coordinates this activity with Quality and Manufacturing
- Develops method validation strategies in support of the Company’s goals and objectives.
- Coordinates analytical method transfers between vendors.
- Oversees all method development for Drug Substance and Drug Product and ensures methods are suitable and sufficient for phase of clinical development
- Oversees all method development and validation for bioanalytical analyses and ensures methods are suitable and sufficient for phase of clinical development
- Oversees method validation activities: reviews and approves all analytical methods, validation protocols and reports.
- Reviews analytical results and supporting documentation in order to ensure quality standards are met for release and stability testing of Drug Substance and Drug Product.
- Works closely with QA in order to allow for release of Drug Product for clinical use.
- Oversees stability program, including assigning shelf life of Drug Substance and Product.
- Reviews data and authorizes acceptance of Certificate of Analysis.
- Key contributor and reviewer of IND, CTA and other Global Regulatory filings.
- Management and coordination of reference standard supplies.
- Other related duties as assigned.
- An advanced degree in Analytical Chemistry and a minimum of 10 years of directly related experience in a similar role, or the equivalent combination of education and experience.
- Experience overseeing and coordinating CMO’s and/or working in a pharmaceutical manufacturing environment.
- Experience with a wide range of Analytical techniques to support the testing and release of a variety of Drug Substance and Drug Product presentations.
- Strong knowledge of cGMP and current quality and regulatory guidelines.
- Strong problem solving, decision making, leadership and communication skills.
- Ability to work independently and as a functional leader and participant in teams.
- Strong written and oral communication skills.
- Business travel up to 20%.
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