Sr. Manager, CMC Development Quality

The Senior Manager, CMC Development Quality is responsible for managing all GMP both Internal and external CMC development quality control activities, liaising with Analytical Development on QC activities, and supporting QC on insourcing project related QC prioritization.

Primary Responsibilities

The Sr. Manager, CMC Development Quality is responsible for the management of the internal GMP and process development activities in support of IND enabling activities as well as external contract test labs to ensure project related activities are aligned with project timelines and to provide technical and quality expertise during external laboratory investigations and CAPA's. Additionally, this role will collaborate with Project Management to coordinate project related activities as they pertain to Quality, and provide mentoring to CMC Development QA team. This role serves as the QA lead for biochemical characterization assay development efforts; reviews and approves external testing data, oversees the execution of viral programs/external stability programs trending and provides quality oversight of early phase development programs in partnership with the development teams.

Specific Responsibilities

-Manage contract test labs to ensure appropriate testing and documentation, and turnaround times are aligned with project timelines

-Provide guidance for the resolution of discrepancies, Out of Specification (OOS), investigations and Corrective and Preventive Actions (CAPA) for outsourced testing

-Liaise with Analytical Development for CMC QC testing prioritization

-Collaborate with Project Management to coordinate Quality activities pertaining to project timelines

-Provide technical and compliance guidance for the implementation and maintenance of QC analytical methods

-Review of CMC submissions as it relates to analytical methods and QC activities

-Participate in internal and external audits and regulatory inspections

-Notify Senior Management of potential quality or regulatory issues that may affect delays to project timelines

Qualifications

-Bachelor's degree in Life Sciences disciplines and 10years of experience in cGMP lab environment or:

-Master's degree in Life Sciences disciplines and 8 years of experience in cGMP lab environment.

-A background in Analytical method development, QC and validation.

-Experience leading technical groups focused in Analytical development.

-Experience managing scientific projects and personnel.

-Knowledge of cGMP, ICH, USP and global compendia regulations and guidance documents

-Experience managing in a GMP environment.

-First hand or intimate knowledge of biochemical, biological and immunological assay development is highly desirable