Senior Scientist, Analytical Development
Gilead Sciences
Summary
As a Senior Scientist, Analytical Development, you'll play a key role in advancing innovative biologic therapies from discovery through early clinical development, helping bring potential new medicines to patients. In this highly collaborative role, you'll drive analytical development strategies for biologic drug substance and drug product, including molecular characterization, analytical method development, control strategy design, and regulatory support. Working closely with scientists and cross-functional partners across Research, Development, and Manufacturing, you'll tackle complex scientific challenges, advance analytical innovation, and support the development of novel therapies. This position is based in Foster City, CA, and requires onsite work five days per week.
Job description
Key Responsibilities
- Lead analytical activities for pre-pivotal Phase I and Phase II biologic molecules.
- Identify molecule-specific critical quality attributes and propose and justify analytical control strategies for biologic drug substance and drug product.
- Author relevant sections of regulatory submissions for biologic drug substance and drug product.
- Develop analytical methods for molecule characterization and release testing.
- Author method development reports, test procedures, validation protocols, and validation reports.
- Oversee internal and outsourced testing, provide guidance on data generation and data integrity, and ensure compliance and analytical excellence at contract organizations.
- Proactively evaluate and implement state-of-the-art technologies and automation to drive innovation in analytical development and testing.
- Build and maintain strong relationships with key stakeholders and provide technical and strategic input to colleagues across Research, Clinical Development, Clinical Supply Management, and Program Strategy.
- Provide technical support for internal and external current Good Manufacturing Practice (cGMP) manufacturing operations.
- Present research findings and recommendations to senior staff; prepare research reports and peer-reviewed manuscripts; and author or contribute to investigational new drug applications and patent filings.
Basic Qualifications
- Bachelor's degree and 8+ years of relevant experience OR Master's degree and 6+ years of relevant experience OR PhD and 0+ years of relevant experience
Preferred Qualifications
- Biologics-relevant analytical development experience in the biotechnology or pharmaceutical industry.
- Experience supporting Chemistry, Manufacturing, and Controls (CMC) activities and Phase I investigational new drug applications for biologic products, including IND support or authoring.
- Strong physical and chemical analytical expertise applicable to biologics, including hands-on laboratory experience with separation-based methods such as UPLC/HPLC, CE-SDS, size-exclusion chromatography (SEC), iCIEF, LC-MS/MS, intact mass analysis, and related separation chemistries.
- Experience developing, validating, and implementing analytical methods, laboratory automation, control strategies, and analytical development control systems for biologic products from late-stage research through Phase I and Phase II development.
- Experience overseeing analytical work performed by contract development and manufacturing organizations (CDMOs), including data generation, data integrity, and compliance.
- Working knowledge of current Good Manufacturing Practice (cGMP) requirements and applicable FDA and ICH guidance for biologic drug substance and drug product.
- Working knowledge of computer system validation, data governance, data science, knowledge management, and data protection.
- Demonstrated initiative, creativity, innovation, curiosity, intellectual humility, and a collaborative approach to scientific problem-solving.
- Strong written and verbal communication skills, with the ability to present scientific findings and provide technical and strategic input to cross-functional internal and external teams.
- Ability to work independently with limited guidance, manage competing priorities, and contribute effectively in a fast-paced team environment.
- Experience training or providing technical guidance to less experienced colleagues.
Requirements
- Bachelor's degree and 8+ years of relevant experience OR Master's degree and 6+ years of relevant experience OR PhD and 0+ years of relevant experience
- Biologics-relevant analytical development experience in the biotechnology or pharmaceutical industry
- Experience supporting Chemistry, Manufacturing, and Controls (CMC) activities and Phase I investigational new drug applications for biologic products, including IND support or authoring
- Strong physical and chemical analytical expertise applicable to biologics, including hands-on laboratory experience with separation-based methods such as UPLC/HPLC, CE-SDS, size-exclusion chromatography (SEC), iCIEF, LC-MS/MS, intact mass analysis, and related separation chemistries
- Experience developing, validating, and implementing analytical methods, laboratory automation, control strategies, and analytical development control systems for biologic products from late-stage research through Phase I and Phase II development
- Experience overseeing analytical work performed by contract development and manufacturing organizations (CDMOs), including data generation, data integrity, and compliance
- Working knowledge of current Good Manufacturing Practice (cGMP) requirements and applicable FDA and ICH guidance for biologic drug substance and drug product
- Working knowledge of computer system validation, data governance, data science, knowledge management, and data protection
- Demonstrated initiative, creativity, innovation, curiosity, intellectual humility, and a collaborative approach to scientific problem-solving
- Strong written and verbal communication skills, with the ability to present scientific findings and provide technical and strategic input to cross-functional internal and external teams
- Ability to work independently with limited guidance, manage competing priorities, and contribute effectively in a fast-paced team environment
- Experience training or providing technical guidance to less experienced colleagues
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Annual Bonus
- Stock-Based Long-Term Incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.