Research Scientist II - Upstream Bioprocess Development
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POST DATE 9/7/2016
END DATE 10/10/2016
Gilead Sciences, Inc
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
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.
This individual will independently plan and execute experiments to support routine cell culture process development for monoclonal antibody, recombinant protein, and novel platform programs. Activities will include clone selection, process optimization, medium and cell culture process platform development, characterization studies, process validation, and contribution to regulatory filings. The successful candidate will drive high titer cell culture process development in an accelerated timeline and serve as upstream development representative on cross-functional teams including CMC project teams, technology transfer teams, and external collaboration teams.
Plan and execute process development activities for biologics programs from pre-clinical process development to licensure and commercial manufacturing.
Troubleshoot and resolve challenges and facility fit issues for GMP clinical and commercial manufacturing.
Lead the design and execution of experiments, including hands-on laboratory operations such as shake flask, bench scale bioreactor, and pilot scale cultures as well as novel culture platforms.
Design and qualify scale-down models and statistical experimental design strategies for process robustness and characterization studies.
May supervise and mentor scientific staff.
Demonstrated excellence in in cell culture process development, process technology transfer, scale translation, and statistical DOE (design of experiments)
Excellent communication, technical report writing, and presentation skills and aptitude for creative problem solving
Experience with the preparation of regulatory filings for US and external markets
Understanding of GMP manufacturing
Strong organizational and planning skills.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Responsible for developing upstream bioprocesses for the manufacturing of drug substances.
Becomes familiar with Pilot Plant operations and able to write master batch records and safety summaries with limited supervision.
Works under supervision of more senior scientists or scientific directors to advance the development of economical, state-of-the-art techniques to isolate, characterize, purify and mass-produce substances.
Working under general supervision, plans designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug substances or techniques to identify such substances.
Advises members of project teams in the initiation and execution of laboratory experimentation, considering various factors.
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
Demonstrates ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
May make contributions to scientific literature and conferences through publication and presentation of research results.
Demonstrates excellent communication skills (both verbal and technical) and strong interpersonal skills.
Demonstrates collaborative communication and problem solving spirit
KNOWLEDGE, EXPERIENCE AND SKILLS
Ph.D in biological sciences or chemical engineering with 3+ years of industrial experience , or MS in similar fields with 10+ years of industrial experience
Excellent writing, presenting, and inter-personal communication skills
Excellent problem solving and troubleshooting skills
Demonstrated success in cell culture process development, process scale-up, and statistical design of experiments
Supervisory experience preferred
Experience preparing regulatory filings for US and external markets
Understanding of GMP manufacturing and large scale facilities
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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.
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