Scientist- Upstream | ServareGMP | Vista, CA

ServareGMP is a new, non-profit public benefit corporation dedicated to developing and manufacturing low-cost biologic medicines for diseases affecting the underserved, the neglected and the most vulnerable populations. Biologic medicines are one of the most important developments in the history of health care. Due to the high cost of development and manufacturing, monoclonal antibodies (mAbs) and other biologics are largely unavailable to populations in low and moderate resource countries (85% of world’s population). Additionally, of the over 100 mAbs approved as treatments by the FDA, as of 2019 only 7 could be classified as treatments for infectious diseases or neglected diseases. As of 2018, the average mAb therapy treatment cost in the United States was $96,731.

ServareGMP was established to help change this through three primary pathways: develop and manufacture very low-cost medicines; utilize its expertise and operations to partner with other like-minded organizations on their efforts to bring forth medicines aimed at vulnerable populations; and collaborate with colleagues in LMICs to launch biomanufacturing operations in those locales.

Servare values inquiries from the same communities it is chartered to serve as well late career scientists and researchers.

Position Pre-requisites:

  • Ph.D. in an applicable scientific field with 2+ years, M.S. with 4+ years, B.S. with +6 years; with industrial experience in process development and/or cGMP manufacturing.
  • Excellent knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.
  • Demonstrated ability to design and implement research plans, DoE and proof of concept work to achieve program goals.
  • Proficiency with manufacturing of products following SOPs, batch records and working within a cGMP regulated environment.
  • Ability to observe technical issues and direct troubleshooting of process and equipment problems.

Position Duties:

  • Development of bioprocessing research programs and projects to achieve organization’s goals.
  • Operates as supervisor of complex systems, technical personnel, and equipment; and optimizes use in bioprocessing and manufacturing in accordance with defined goals.
  • Assists CSO in performance of bioprocessing and manufacturing efforts.
  • Develops and overseas upstream scientists and research associates and integrates them into a cohesive team, valuing all members of the organization.
  • Operates and maintains production equipment as it relates to cell culture.
  • Leads manufacturing in research and clinical scale protein production and manufacturing of final products.
  • Works closely with downstream/purification team to ensure efficient and effective transfer of process to that team.
  • Performs a variety of complex tasks under general guidance and in accordance with current GMPs.
  • Maintains records to comply with regulatory requirements and assists with in-process testing.
  • Provides detailed observations, analyzes data, and interprets results.
  • Responsible for implementation or revision of equipment, documentation, and material aspects of process.
  • Prepares technical reports, summaries, protocols, batch records and quantitative analyses.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Organizes upstream team daily workload schedule and relevant resource requirements.
  • Supports multiple projects simultaneously.
  • Proposes, develops, and implements production procedures to optimize manufacturing processes.
  • Monitor processes as well as results and suggest methods to ensure process success.
  • Provides training to new personnel.
  • Provides feedback to Senior Management on personnel performance.

Position Responsibilities:

  • Responsible for specific product-related operations in cell culture/fermentation.
  • Responsible for mentoring and training of production associates and leads in process transfer, scale-up, from a scientific and engineering perspective.
  • Ensures compliance with GMP and all its related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports, and records.
  • Develops effective working relationships with both internal and external partners.
  • Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
  • Operates to the highest ethical and moral standards.
  • Complies with ServareGMP policies and procedures.
  • Adheres to quality standards set by federal and state regulations and ServareGMP policies, procedures, and mission.
  • Communicates effectively with Executive Director, CSO, colleagues and subordinates.
  • Travels as needed for career development, technical training, evaluation/integration of new technologies, and support tech transfer for client projects.

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