Sr Associate II, Biologics Technical Operations - Purification

Gilead Sciences, Inc. Oceanside , CA 92049

Posted 3 weeks ago

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Gilead has an opportunity for an experienced candidate in Biologics Technical and Manufacturing Operations at our Oceanside facility in Southern California. We are seeking motivated, team oriented individuals with expertise in purification operations and technical transfer of recombinant proteins. Reporting to the Director of Technical Operations, you will have the opportunity to participate in technology transfer of monoclonal antibody purification processes to internal and external manufacturing sites.

Specific responsibilities and skills for Position:

  • Support Gilead biologics purification technical operations by enabling timely and successful technology transfer of downstream manufacturing processes to external partners (CMOs)

  • Perform facility fit assessments and identify process gaps and generate solutions to ensure successful process fit into internal and external manufacturing plants

  • Collaborate with the Process Development, Manufacturing, and Upstream Technical Operations to ensure successful technology transfer of biologic processes including evaluation of the automation and process control strategy, bill of materials, and master batch record drafting/review

  • Monitor and evaluate purification process performance data, report and present findings

  • Support and drive yield improvements and process efficiencies

  • Lead/coordinate cross-functional projects with limited direction

  • Independently plan and execute experiments in a pilot or laboratory setting in support of process optimization initiatives or manufacturing technical assessments

  • Apply knowledge of current Good Manufacturing Practices (cGMPs)

  • Contribute to and/or lead technical investigations of process deviations and assessment of impact on product quality

  • Identify areas for improvement or optimization, lead implementation of best practices, and present data to applicable departments on the outcome of investigations or optimization initiatives

  • Coordinate or support implementation of new technologies onsite and at CMOs.

  • Serve as a subject matter expert during purification operations; provide technical troubleshooting and investigative support during internal and external manufacturing runs.

Essential Duties and Job Functions:

  • Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)

  • Demonstrates excellent verbal, written and interpersonal communication

  • Works on non-routine to somewhat complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action

Knowledge, Experience and

Skills:
  • 5+ years of experience with BS degree in a relevant scientific discipline.

  • 3+ years of experience with MS degree in a relevant scientific discipline.

Preferred training and experience:

  • Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline

  • Prior experience in a Technical Operations/MSAT purification role including technology transfer of biologics to contract manufacturing sites

  • Knowledge of cGMPs and validation requirements in all clinical phases

  • Antibody experience is required. Familiarity with monoclonal antibody downstream platforms, centrifugation, chromatography, and filtration. Biologics experience with alternative modalities, expression systems, antibody design variants, and/or cell therapy is a plus

  • Must be able to work effectively in cross-functional teams

  • Must demonstrate excellent technical writing skills

#LI-JS1

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 careers@gilead.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:

Please log onto your Internal Career Site to apply for this job.


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Sr Associate II, Biologics Technical Operations - Purification

Gilead Sciences, Inc.