Associate Scientist Biologics Drug Product Development, Technical Operations
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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Job DescriptionAssociate Scientist - Biologics Drug Product Development, Technical 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.
Gilead Sciences has an opportunity for an experienced candidate in our Biologics Drug Product Development Technical Operations group at our site in Oceanside, CA. We are seeking motivated, team-oriented individuals with scientific experience in process development and/or manufacturing related to biologics.Essential Duties and Job Functions:
- A strong understanding of drug product process development for early and late stage biologics.
- Experience in supporting the tech transfer of parenteral, biologics drug product processes to early phase and late phase clinical manufacturing sites. Defining and reviewing batch records and enacting technical operations business and quality processes
- May provide person-in-plant support during GMP manufacturing, support ongoing manufacturing operations and release, as well as assist in quality investigations as necessary.
- Trend manufacturing data and evaluating discrepancies
Knowledge, Experience and Skills:
- May perform process development experiments, scale-down/-up experiments to define drug product process parameters, and to author protocols, summary reports, as well as sections of regulatory submissions.
- Experience in lyophilized drug product process development, mixing, filtration, and filling process unit operations.
- Has knowledge pertaining to global cGMP regulatory and guidance documents, such as those from the FDA, EMEA, ICH, US/EU Pharmacopeias, etc., related to drug product manufacturing.
- Be an effective communicator of ideas, project goals and results in both written and presentation format. The candidate should have the ability to proactively identify issues, make key insights to data, and develop solutions in a collaborative multidisciplinary environment.
- Candidates should be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.
- A minimum of 5+ years' industry experience with BS degree in related scientific discipline or 3+ years' industry experience with MS degree in related scientific discipline.
- Degree in Pharmaceutical Sciences, Chemical/Biochemical Engineering, Biochemistry or a related scientific discipline and relevant industry experience that demonstrates expertise in process development or drug product technical operations as well as sustained excellence in performance and accomplishments that align to company goals.
- Excellent communication skills (both verbal and technical) and interpersonal skills are required.
- Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in providing manufacturing/process development approaches and troubleshooting.
To apply, please submit resume through our website at www.gilead.com
Gilead is an equal opportunity employer.
The salary range for this position is: $109,480.00 - $141,680.00. 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.
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