GeneCoda has been engaged to identify and evaluate candidates for a Senior Manager or Associate Director of Small Molecule Quality to ideally be located in the Research Triangle Park, NC or Northern, NJ marketplace.
About Our Client:
Our client is an innovative, commercial-stage biopharmaceutical company developing medically important pharmaceutical products in Oncology and other therapeutic areas with unmet needs.
The Senior Manager / Associate Director, Small Molecule Quality is responsible for supporting GMP activities performed at Contract Manufacturing Organizations (CMO / CDMO) including manufacturing, testing, and packaging of products both in clinical development and commercial distribution stages. The Senior Manager / Associate Director, Small Molecule Quality will manage CMO compliance with cGMP and quality systems, including but not limited to change control, manufacturing deviations, laboratory investigations including OOS results, process, equipment and facilities validation and qualification, analytical method validation and transfer, technology/site transfer, retain sample management, reference standard management and adherence to the Quality Agreement.
- Perform batch record review and batch disposition for GMP intermediates, APIs, drug products including packaging records to support commercial and clinical manufacturing. Review analytical data as needed / applicable.
- Review protocols and reports for stability, validation, and other studies, COAs, COC, and other development and GMP documents.
- Work with CMO’s to conduct manufacture deviation and laboratory investigations. Review and provide comments, perform risk assessments of impacted product and tracking and approval of CMO deviations and investigations and generation and implementation of associated CAPAs.
- Conduct complaint investigations for both clinical and commercial products. Work with CMO’s to adequately address complaints, identify trends, assess product impact, and complete complaint investigations within quality systems.
- Work with CMO’s and partners to evaluate and determine impact to product and regulatory submissions and implement change controls both internally and at CMO’s.
- Work with internal CMC, Regulatory and Supply Chain/Logistics to gain agreement on priorities, impact, and execution plans to support commercialization of new products and ongoing commercial operations.
- Support person in plant initiatives at CMO’s as needed both domestically and internationally.
- Travel approximately 15-20% of time including internal sites and CMO manufacturing sites (both domestic and international). Frequency of travel may increase for short durations in order to meet critical business needs.
Education: Bachelor of Science degree in a scientific discipline, technology, engineering, or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 7 or more years of experience in a GMP Quality Assurance, Quality Control, development, or manufacturing environment.
- Experience with CMO management is required, i.e., either worked for or with CMO’s in a current or previous job.
- Broad working knowledge of global regulations (i.e., ICH guidance, FDA/EMA GMP regulations, etc.) for manufacturing, packaging and distribution of API and finished products.
- Small molecule drug development experience highly preferred.
- Strong collaborative skills. Team player mentality.
- Critical reasoning skills and demonstrated ability to assess impact of planned and unplanned changes on product quality.
- Ability to troubleshoot, identify root causes and systematically resolve problems.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.