Sr Associate Scientist, FPD

仕事内容

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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. A Sr. 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 moderate to high complexity experiments. May be a subject matter expert on one or more pieces of equipment.

• Designs and executes moderately complex 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 manufacture of GMP clinical and/or development drug products batches.

• Develops and optimizes manufacturing processes.

• Works collaboratively with peers from other departments and external partners.

• Trains less experienced colleagues on techniques required for their duties, while ensuring that quality, safety and environmental standards are maintained.

• Assists in preparation and review of GMP documentation.

• Summarizes experimental results and presents conclusions in team meetings and departmental presentations.

• Authors templated memos and reports. Authors medium complexity non-templated memos and reports with minimal guidance. May work with more experienced colleagues on low complexity sections for IND/IMPD and/or NDABLA submissions.

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.

• Acts as a resource for other colleagues within the department.

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.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

The salary range for this position is: $126,820.00 - $164,120.00. 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.

For jobs in the United States:

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 ApplicantAccommodations@gilead.com for assistance.

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

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For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.