Sr. Manager (Analytical Scientist), MS&T Analytical Operations
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
- Lead and be hands-on with 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.
- Lead the 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.
- Review and summarize 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.
- Lead biologics testing support for mAb/DS/DP processes, provide strategic leadership to analytical testing services to ensure adequate resources and technologies are in place to support high throughput processing, and accurate and fast delivery of results.
- 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.
Knowledge, Experience & Skills:
- Ph.D. in Biological Sciences, Analytical Chemistry, Pharmaceutical Sciences, or relevant field preferred
- 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.
- Master’s degree and 6+ years of relevant experience; or Bachelor’s degree and 8+ years of experience in the pharmaceutical industry.