THE ROLEWe are seeking an experienced and highly motivated Senior Manager of Analytical Quality Control to manage analytical development and quality control activities on our small molecule programs with manufacturing and testing at Contract Development and Manufacturing Organizations (CDMOs). This individual will leverage expertise in analytical data review and data trending to effectively manage stability studies, reference standards, and technical change controls.
Responsibilities- Provide QC oversight of analytical testing and stability studies performed at CDMOs for reference materials, drug substance, drug product, placebo, and finished goods and perform in-depth reviews of raw analytical data to ensure data integrity and compliance with specifications.
- Establish and maintain processes for tracking and trending of CDMO testing against release and stability schedules.
- Manage reference standards and reference materials including qualification, retest date and requalification, and inventory tracking.
- Author and review stability summary reports based on stability data report and including scientific justification of drug substance retest periods and drug product shelf-life in alignment with industry standards and regulatory guidelines.
- Support development of and maintain compliance with the quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
- Review analytical method validation protocols and reports, change controls, corrective and preventative actions, deviations, and investigations, including OOS and OOT events.
- Author, review and verify data in CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents, while remaining current on Health Authority guidance and expectations.
- Support the evaluation, selection, and management of CDMOs to perform reference standard management, GMP manufacture, release testing, and stability studies.
- Collaborate cross functionally with teams including Analytical Development Process Chemistry, Pharmaceutical Development, Supply Chain Management, Quality, Regulatory, DMPK, Toxicology, and Clinical Pharmacology to achieve project goals.
Qualifications- A BS, MS, or PhD degree in analytical chemistry or related field with a minimum of 10 years, 8 years, or 5 years, respectively, of relevant industry experience with demonstrated increasing responsibilities within analytical quality control.
- Demonstrated execution of QC activities supporting programs through clinical development.
- Demonstrated experience performing and managing analytical method development, phase appropriate method qualification/validation, and release and stability testing.
- Knowledge of analytical techniques for small molecules and oral solid dose products. Must be proficient in IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests.
- Proven proficiency working with quality systems including SOPs, protocols and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, Deviations, and Change Management.
- Experience applying compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
- Demonstrated experience managing and collaborating with external partners, including CDMOs.
- Exhibited strong organizational and critical thinking skills with an attention to detail facilitating efficient data, document, and knowledge management across CMC.
- Excellent interpersonal and communication skills (written and oral) with the ability to effectively and concisely present data to peers, management, and external groups.
- Effective management of multiple priorities in a fast-paced environment.
- Ability to travel domestically and internationally as needed, up to 10% of the time.
The anticipated salary range for candidates who will work in South San Francisco, CA is $175,000 - $195,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
