Sr. Manager/Associate Director/Director, Drug Substance Development and Manufacturing
RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative biologics for the treatment of cancers, autoimmune and ophthalmic diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen, a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.
We are expanding our development capabilities at San Francisco site. We are currently seeking an experienced and highly motivated Sr. Manager/Associate Director/Director of CMC Drug Substance Development amp; Manufacturing to join our CMC Development amp; Manufacturing team. The position is in South San Francisco, CA and reports to the Vice President, CMC Development amp; Manufacturing.
As a member of CMC Development amp; Manufacturing team, the incumbent will play a key role in supporting Drug Substance process development and validation. The incumbent will serve as Subject Matter Expert (SME) and author drug substance CMC sections for regulatory submissions (both upstream and downstream). A successful candidate must have in-depth understanding of drug substance development process, demonstrate the ability of influencing the direction of the programs from the process development through commercialization, and enjoy working in a cross functional, dynamic and fast-paced environment during a period of significant growth.
Requirements
Responsibilities (including, but not limited to):
- Responsible for providing guidance for all aspects of drug substance process development and process validation through commercialization (including both upstream and downstream).
- Serves as a subject matter expert in drug substance process development, scale-up, process transfer, process characterization, process validation, and GMP manufacturing.
- Author, review and approve technical reports related to process development, technology transfer, process characterization and process validation for both upstream amp; downstream processes.
- Author drug substance relevant sections in IND/CTD/BLA/MAA, interact with regulatory agencies, and responsible for developing responses to drug substance related questions raised during regulatory filings and inspections.
- Support drug substance manufacturing GMP compliance audits.
- Serve as a SME in supporting drug substance batch manufacturing and releasing, batch records review and deviation investigation.
- Serve as a SME in providing strategic recommendations leading to improved cost of goods, process yields and process robustness.
- Work closely with QA to develop and implement SOPs and specifications to ensure drug substance meets established quality standards.
- Support additional development activities and subsequent technology transfer and manufacturing of the drug substance post launch, as needed.
Qualifications:
- A Ph.D. degree in a Pharmaceutical Sciences, Biochemistry, or Protein Chemistry is required. Equivalent experience may be accepted. A minimum of 5 years of industrial experience in drug substance development and registration for therapeutic proteins.
- Prior experience with drug substance process characterization, process performance qualification and commercial manufacturing for therapeutic proteins.
- Working knowledge of US and EU cGMP and ICH guidance and relevant standards and quality system requirements regulations and guidelines for biologics drug substance manufacturing.
- Ability to lead and challenge multifunctional teams, facilitate decision-making, work effectively in cross-cultural environments.
- Strong communication (oral and written) communication, organizational and project management skills.
- Must be a demonstrated self-starter and team player with strong interpersonal skills.
- In-depth knowledge of worldwide regulatory requirements for drug substance (both upstream and downstream) CMC sections of INDs. BLAs and MAAs etc is required.
- Experience in authoring IND/BLA submission documents and relevant technical documents is highly desired.
- Experience in planning and executing late-stage Design of Experiment (DoE) studies, control strategy, process performance qualification is desirable.
- Experience with l