Associate Scientist, FPD

Biopharma Careers; Foster City (CA); On-site; USD 110,000 - 142,000; Full time

Job summary

Gilead Sciences Inc. is seeking an Associate Scientist within the FPD group in Foster City, CA. The role supports formulation development, manufacturing process development, and tech transfer from development through scale-up at internal and external sites.

The candidate will help establish robust DP formulation strategies and contribute to regulatory filings from IND to NDA. The position involves performing and overseeing GMP clinical manufacturing and cross-functional collaboration, with

Qualifications

• BS degree in related scientific discipline with 5+ years of experience or MS degree with 3+ years of experience.
• Experience must be in related scientific discipline.

Responsibilities

• Organizes, files and retrieves project-related records.
• Maintains the proper functions of laboratories.
• Operates laboratory instrumentation and/or processing equipment and can train others to conduct low to moderate complexity experiments.
• Designs and executes low to moderate complexity experiments in support of cross-functional projects.
• Troubleshoots analytical methods, instrument operation, manufacturing and experimental design.
• Performs drug substance, drug product intermediate and drug product characterization.
• Oversees routine GMP clinical manufacture of drug products and/or development batches.
• Works collaboratively with peers from other departments and external partners.
• Summarizes experimental results and presents conclusions in team meetings and department presentations.
• Authors templated memos and reports. Authors medium complexity.

Education

BS degree in related scientific discipline

MS degree in related scientific discipline

Job description

Job Description

Small Molecule Formulation and Process Development (FPD) provide formulation, process, and manufacturing support and technical expertise throughout research and development, from pre-exploratory to commercialization. An Associate Scientist within FPD may support teams conducting compounding screening to enable drug candidate selection, drug substance physio/chemical property assessment and form selection, development of clinical formulations and manufacturing processes, small molecule drug product manufacturing tech transfer and scale-up at internal and external sites, oversight of small molecule drug product manufacturing, and establishment a robust DP formulation and optimized manufacturing process to enable commercial production. FPD formulation scientists develop the small molecule formulation and manufacturing process control strategies and authors technical reports, risk assessments, and regulatory filings from IND to NDA. FPD supports DP manufacturing process validation and provides technical expertise throughout post-approval commercial manufacturing and life-cycle management.

Job Responsibilities

Administrative

• Organizes, files and retrieves project-related records.
• Maintains the proper functions of laboratories.

Technical

• Operates laboratory instrumentation and/or processing equipment and can train others to conduct low to moderate complexity experiments.
• Designs and executes low to moderate complexity experiments in support of cross-functional projects.
• Troubleshoots analytical methods, instrument operation, manufacturing and experimental design.
• Performs drug substance, drug product intermediate and drug product characterization.
• May oversee routine GMP clinical manufacture of drug products and/or development batches.
• Works collaboratively with peers from other departments and external partners.
• Summarizes experimental results and presents conclusions in team meetings and department presentations.
• Authors templated memos and reports. Authors medium complexity.

Safety & Compliance

• Follows Environmental, Health and Safety (EHS) Policies and FPD-specific safety protocols.
• Maintains workplace compliance to achieve no violations or major observations during EHS or regulatory agency inspections.
• Completes all required safety and GMP training by the required due date.
• Ensures that standard operating procedures (SOPs) are followed as written, and required information is recorded properly.
• Accurately documents results in electronic lab notebook.

General

• Applies Gilead Core Values and Leadership Commitments to job responsibilities.
• Demonstrates good verbal communication and interpersonal skills.
• Works with a collaborative communication and problem-solving spirit.

Education & Experience Requirements

5+ years of experience with BS degree in related scientific discipline.

OR

3+ years of experience with MS degree in related scientific discipline.

The salary range for this position is: $109,650.00 - $141,900.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.