Sr. Associate Scientist (Biologics Drug Product Development))
Sr. Associate Scientist (Biologics Drug Product Development))
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. Gileads 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 companys five core values. Thats 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.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Essential Duties and Job Functions:
- A strong understanding of formulation and drug product process development for early and late stage biologics. Expected to design and execute studies supporting formulation development, scale-down/-up experiments to define drug product process parameters, and to author protocols, summary reports, as well as sections of regulatory submissions.
- Experience with a range of biologics modalities and delivery methods. Modalities could include antibodies, fusion proteins, bi-specifics, vaccines, antibody-drug conjugates, etc. In addition, the candidate is expected to design and execute experiments evaluating IV infusion delivery methods using bags/bottles and syringe pumps, as well as evaluate subcutaneous injection delivery methods.
- Experience in variety of biochemical (e.g., chromatography, capillary electrophoresis) and/or biophysical techniques (e.g., DLS, FTIR, CD, AUC, fluorescence spectroscopy etc.) is strongly preferred.
- Experience in lyophilized drug product formulation development, process development, and related laboratory techniques, such as freezedrying microscopy, Karl-Fisher moisture analysis, and differential scanning calorimetry, is also preferred.
- Leads drug product technology transfers from process development to clinical and commercial manufacturing sites, serves on-site as a site technical representative for process scaleup studies and technical support during GMP operations. Authors tech transfer documentation defining the process and parameters, as well as reviews master batch records for accuracy.
- Has knowledge pertaining to global cGMP regulatory and guidance documents from the FDA, EMEA, ICH, US/EU Pharmacopeias, etc., related to drug product development, analysis, and manufacturing.
- Be an effective communicator of ideas, project goals and results to crossfunctional teams in both written and presentation format.
- The candidate should have the ability to proactively identify issues, make key insights to data, and work independently to develop solutions in a collaborative multidisciplinary environment.
- Mentors junior scientists, manage multiple projects and ensure project deliverables are met within timelines
- Candidates should be self-motivated, organized, and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.
Knowledge, Experience and Skills:
- A minimum of 11+ years' industry experience with BS degree in related scientific discipline or 9+ years' industry experience with MS degree or 0 years with PhD 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 formulation process development 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 suggesting experimental design and research strategy.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
For Current Gilead Employees and Contractors:
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