Sr. Manager/Associate Director/Director, CMC Analytical…

Empresa: Remegen Biosciences
Tipo de empleo: A tiempo completo

Sr. Manager/Associate Director/Director, CMC Analytical Development
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 Analytical Development to join our CMC Development & Manufacturing team. The position is in South San Francisco, CA and reports to the Vice President, CMC Development & Manufacturing.
As a member of CMC Development & Manufacturing team, the incumbent will play a key role in supporting product characterization, analytical method development/validation. The incumbent will serve as Subject Matter Expert (SME) and author analytical and stability CMC sections for regulatory submissions. A successful candidate must have in-depth knowledge and extensive experience in developing a wide array of analytical protein characterization and biophysical methods, and enjoy working in a cross functional, dynamic and fast-paced environment during a period of significant growth.
Responsibilities (including, but not limited to):
* Responsible for providing guidance on design and execution of phase-appropriate analytical strategies including product and reference standard characterization, analytical method development and qualification/validation, quality control testing under cGMP.
* Author, review and approve technical reports including analytical method development and validation, analytical comparability, reference standard characterization, stability and product shelf life projection, etc.
* Author analytical and stability sections in IND/CTD/BLA/MAA, interact with regulatory agencies, and responsible for developing responses to analytical method development, qualification/validation, comparability, reference standard qualification, and stability related questions raised during regulatory filings and inspections.
* A thorough understanding of relevant ICH guidelines and health authority expectations is required.
* Partner with other departments to manage activities related to analytical method development for combination product and prefilled syringe, characterization activities for starting materials, process intermediates, novel excipients, and drug products.
Requirements
Responsibilities (including, but not limited to):
* Responsible for providing guidance on design and execution of phase-appropriate analytical strategies including product and reference standard characterization, analytical method development and qualification/validation, quality control testing under cGMP.
* Author, review and approve technical reports including analytical method development and validation, analytical comparability, reference standard characterization, stability and product shelf life projection, etc.
* Author analytical and stability sections in IND/CTD/BLA/MAA, interact with regulatory agencies, and responsible for developing responses to analytical method development, qualification/validation, comparability, reference standard qualification, and stability related questions raised during regulatory filings and inspections.
* A thorough understanding of relevant ICH guidelines and health authority expectations is required.
* Partner with other departments to manage activities related to analytical method development for combination product and prefilled syringe, characterization activities for starting materials, process intermediates, novel excipients, and drug products.
Qualifications:
* A Ph.D. degree in Analytical Chemistry or related discipline.
* A minimum of 5 years of relevant industrial experience in analytical development field is required.
* In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, spectrophotometry, LC/MS, peptide mapping and light scattering, etc.)
* Experience with analytical method development, qualification/validation for combination product including prefilled syringes is preferred.
* Strong communication (oral and written) communication, organizational and project management skills.
* In-depth knowledge of worldwide regulatory requirements for analytical and stability CMC sections of INDs. BLAs and MAAs etc is required.
* Experience in authoring IND/BLA submission documents and relevant technical documents is highly desired.
* Strong writing skills and extensive experience in preparation CMC analytical and stability sections regulatory filings including BLA section authorship is strongly preferred.
* Working knowledge of US and EU cGMP and ICH guidance and current industry practices.
* Ability to lead and challenge multifunctional teams, facilitate decision-making, work effectively in cross-cultural environments.
* Multiple languages ability is preferred, but not required.
* Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
Benefits
401(k), 401(k) matching, Dental insurance, Health insurance, Paid time off, Vision insurance.