Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Sr Manager, Development QA
Scope: This position develops Quality strategy for compounds in development (small molecules) for CMC activities. The incumbent will be responsible for multiple projects.
Responsibilities include, but are not limited to, the following:
- Member of CMC Development Teams providing Quality input from pre-clinical to NDA filing. Partners with technical SMEs to develop and approve the CMC strategy for new drug candidates.
- Final Quality reviewer/approver for GMP documentation; including analytical related documents (Testing Methods, Specifications, Method/Stability Validation Protocols and Reports).
- Responsible for change control management through the development process to include impact assessments, tracking, and implementation. Also, responsible Quality member for oversight of all key Quality Systems associated with the drug development candidate including Change Controls, Deviations, CAPAs, and Complaints.
- Work with CMC Teams to conduct risk assessments, as required, for all aspects of the drug development process. Responsible for providing Quality risks to the CMC sections of the IND/NDA.
- Track/Own ongoing regulatory updates to Health Authorities (e.g. IND/NDA) from a quality perspective including specifications, shelf life extensions, country specific trial approvals etc.
- Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful NDA approval. Knowledge of multiple pharmaceutical dosage forms (Solids /Parenteral etc.) would be considered an advantage.
- Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
- Well-versed in relevant CMC area with an ability to introduce Quality relevant best practices into the CMC Development Process
- Excellent investigational and QA problem solving skills. Analytical mind, ability to assess new situations to define and implement the appropriate QA action plan.
- Work independently, yet effectively in a team environment.
- Strong attention to detail, excellent verbal and written communication skills.
- Teamwork oriented and ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
Education and Experience
- Minimum of B.S. degree preferably in Chemistry, Pharmacy, or similar Science field.
- Minimum 12 years of experience in GMP environment of Rx Drug Development (CMC activities).
- Prior experience in Quality is preferred.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.