Manager (Sr. Associate Scientist), MS&T - AOUnited States - New Jersey - Morris PlainsManufacturing Operations & Supply ChainRegular
- Execute analytical method validations and transfers within internal and external CTLs and CMOs for Biologics and Anti-body Drug Conjugates (ADCs).
- Review/comment the documents for analytical method development reports, method validation/verification/transfer protocols and reports, specifications, test results, stability protocol/report and investigation report to support the development/testing of mAb upstream and downstream, drug substance (DS), starting material, intermediate and drug product (DP) at CTLs/CMOs/CROs.
- Collaborate with Gilead Biologics functions such as Quality Assurance, Process Development, Biologics Business Support Organization, and Outsourcing as well as CTLs and CMOs to establish and justify specifications for mAb, DS, starting material, intermediates, and DP.
- Support with establishment of appropriately robust and reliable GxP analytical methods for internal and external QC testing to support manufacturing activities at both internal and external manufacturing organizations.
- Work closely with QA organization to assure the quality of analytical methods, mAb, drug substance, and drug product, and provide technical comments for troubleshooting, OOS/OOT investigations and deviations.
- Support in reviewing and summarizing analytical data (including stability data) from CTLs/CROs/CMOs, conduct trend analysis, provide feedback and recommendation in assisting the timely resolution of technical and/or quality issues.
- Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
- Apply analytical lifecycle management principle for establishment and continuous improvement of analytical control strategy.
- Maintain strong knowledge of GMPs and manage external CTLs and CMOs.
- Collaborate with process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
- Perform critical data review and provide directions for troubleshooting and investigation.
- Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author sections of regulatory submissions.
- Serve as an analytical representative on CTLs and CMOs tech transfer project teams.
- Perform other duties as required.
Essential Education, Experience & Skills:
- M.S. with 5+ years, OR a BA/BS with 7+ years of experience. (Degrees should be in Chemistry, Biology or a closely related field)
- Must have practical working knowledge of ICH guidelines and GMP requirements for development and manufacturing of Biologics and/or ADCs, analytical method development and transfers
- Experience supporting multiple regulatory filings including BLA/MAA and supporting product-related inspections for US and foreign regulatory agencies
- Experience working with external manufacturing and testing organizations
- Applies the principles and techniques of Analytical Chemistry to biologics development. Strong scientific background in protein chemistry and biologics analytical methods.
- Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize biologics.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
- Demonstrates emerging ability in troubleshooting analytical methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- May make contributions to scientific literature and conferences or regulatory filings.
- Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
- Experience in BLA and global regulatory submissions.
- Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Strong analytical skills and ability to distill key information from various data sources.