Associate Scientist - Upstream

Job Description

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.

The Associate Scientist role is focused on commercial technology transfer. We are seeking motivated, team-oriented individuals with experience in biopharmaceutical upstream drug substance processing. The individual will support technology transfer activities including facility fit & gap assessments, capital improvements, risk assessments, and process validation. They will also work with Contract Manufacturing Organizations to establish commercial manufacturing processes for Gilead products, implementing continuous process verification, and providing technical support during manufacturing and quality investigations.

Job Responsibilities

· Participate on Global Biologics Manufacturing Sciences & Technology (MSAT) project teams in support of technology transfer and validation of biologics drug substance or drug product manufacturing processes.

· Contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management. Author reports associated with these activities.

· Follow GMP quality change management procedures to ensure timely and successful technology transfer activities. Partner with process development, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.

· Collaborate with process development group to support process characterization activities and establishment of design space to support commercial tech transfer and validation. Assist with experimental design and review of results.

· Review technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.

· Contribute to process validation sections of regulatory filings in support of commercial launch/expansion.

· Support ongoing commercial production of Gilead products, as needed, through GMP change management, manufacturing support, deviation investigations.

· Up to 20% travel in support of the above activities

Qualifications

· Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: MS with 2+ years of relevant work experience, BS with 4+ years of relevant work experience

· Understanding of upstream biologics drug substance manufacturing processes e.g., mammalian cell culture in bioreactors & harvest/recovery

· Experience supporting biologics manufacturing operations, technology transfer, and/or development.

· Working knowledge of GMPs and regulatory requirements of biopharmaceutical manufacturing is preferred

· Excellent troubleshooting skills and ability to solve complex technical issues.

· Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

· Excellent and effective verbal and written communication skills