Manager / Senior Manager, Analytical Development & QC
Location: South San Francisco, California, United States
The manager/senior manager is responsible for analytical development and quality control activities to support the small molecule programs at Assembly Biosciences. This person will directly support the development activities including analytical method development and optimization, phase appropriate method validation / verification/ transfer, material characterization and product evaluation studies, specifications setting, release, stability testing, OOS/OOT investigations and change controls for both drug substance and drug product.
Key responsibilities include:
- Assist/support analytical development and quality control activities for both drug substance and drug product in Virology. Review/comment the documents for analytical method development report, method validation/verification/transfer protocol and report, specifications, test results, stability protocol/report and investigation report to support the development/testing of drug substance (DS), starting material, intermediate, and drug product (DP) at CMOs/CROs
- Collaborate with other Assembly team members such as CMC, RA, and QA as well as CMOs to establish and justify specifications for DS, starting material, intermediates, and DP
- Work closely with Assembly QA to assure the quality of analytical methods, drug substance, and drug product, and provide technical comments for troubleshooting, OOS/ OOT investigations and deviations
- Review and summarize analytical data (including stability data) from CROs/CMOs, conduct trend analysis, provide feedback and recommendation in assisting the timely resolution of technical and/or quality issues
- Author and/or review the analytical sections of regulatory submission documents
- Perform other duties as required
Preferred Qualifications include:
- Candidates at the Manager level should have a Ph.D. in a relevant technical field with 3+ years of experience in pharmaceutical analytical development. Candidates at the Senior Manager level should have substantial additional experience. Candidates with a non-Ph.D. degree but with significant industry experience will be considered
- Proven experience managing contract testing laboratories, and hands-on experience working in analytical laboratories in the pharmaceutical industry
- Experience in analytical and regulatory requirements, including strong knowledge of cGMPs, ICH, FDA, EMA, NMPA, USP and other relevant regulatory requirements.
- Familiar with analytical techniques including HPLC, GC, dissolution, IPC, particle size analysis, KF titration, UV, XRPD and DSC/TGA etc.
- Self-directed and motivated, and willing to take challenges in new areas
- Effective communication, collaboration, and organization skills
- Able to handle multiple projects effectively
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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