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Research Scientist, Process Development

Employer
Gilead Sciences
Location
Oceanside, CA
Closing date
Aug 8, 2022

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Sector
Science
Organization Type
Corporate
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Research Scientist, Process Development - Oceanside, CA

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 has an opportunity for a scientist level in our Downstream Process Development group at our Oceanside facility in Southern California. We are seeking a highly motivated, team-oriented individual to support downstream process development for our rapidly growing biologics pipeline.

Key Responsibilities:
  • Demonstrates hands-on technical leadership of all aspects of purification process development including chromatography, TFF and depth filtration
  • Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis
  • Responsible for technology transfer to manufacturing facility and provide technical input and support during manufacturing of drug substances
  • Author or review GMP or non-GMP technical documentation (development reports, process description, batch records, etc)
  • Author and review CMC related regulatory sections such as IND, IMPD and BLA
  • Demonstrates technical proficiency and scientific creativity in improving platform technology
  • Demonstrates ability in communicating of ideas, project strategies and results to team members across functional roles/departments
  • Mentor and develop junior scientists

Qualifications/Skills/Experience:
  • Ph.D. and 0-3 years of experience in a relevant scientific discipline (biochemistry, bioengineering, chemical engineering, chemistry, etc)
  • MS or BS degree with extensive industry experiences
  • Hands-on experience of protein purification, thorough understanding of chromatography and familiarization of AKTA are required
  • Broad understanding of downstream development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is preferre
  • Experience in tech transfer and familiarization of pilot plant and GMP manufacturing is preferred
  • The ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment is essential
  • Excellent communication skills and strong interpersonal skills are desirable
  • Experience in statistics and data analysis (e.g. JMP, Spotfire) is a plus
  • Experience in regulatory fillings is a plu
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