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Lead Process Engineer, Biopharmaceutical Manufacturing

2 months ago

Fremont, California, United States Planet Pharma Full time

Shift Information: 1st Shift: 8:00AM-5:00PM; occasional work outside of standard hours may be required due to the 24/7 operational nature.

Key Responsibilities:

  • Oversee processes and operations of medium to high complexity within the biopharmaceutical sector.
  • Assess, transfer, and implement innovative processes into Planet Pharma's GMP facility for the production of biopharmaceutical drug substances.
  • Manage process transfers for both internal products and external contract manufacturing clients, ensuring seamless integration into the multi-product facility.
  • Develop and apply innovative solutions to complex challenges utilizing cutting-edge technology.
  • Provide scientific and technical support throughout process transfers, product launches, and initial supply phases.
  • Act as the technical liaison between large-scale manufacturing and clients within a collaborative project framework, ensuring compliance with GMP and regulatory standards.
  • Guide and mentor junior team members, offering strategic direction and technical leadership while supporting troubleshooting and continuous improvement initiatives.
  • Serve as the technical lead for assigned upstream and/or downstream processes of moderate complexity, including but not limited to cell culture, bioreactors, primary harvest, and liquid chromatography.
  • Identify and implement enhancements to at-scale manufacturing technology to optimize GMP operations.
  • Plan and execute activities as a subject matter expert, collaborating with cross-functional teams and external clients to meet project timelines and quality standards while managing risks.
  • Lead evaluations of process requirements and facility-fit assessments for medium to high complexity projects, ensuring alignment with standard manufacturing practices and regulatory compliance.
  • Author and maintain comprehensive technical documentation for complex at-scale processes, including Process Descriptions, Bill of Materials, and Engineering Run Reports.
  • Monitor and analyze large-scale manufacturing processes, developing data repositories and visualizations to track and report on process performance.
  • Contribute to the design and planning of small-scale studies aimed at enhancing at-scale manufacturing processes.

Required Skills:

  • Proven ability to independently plan, execute, and deliver results with minimal oversight.
  • Experience collaborating within cross-functional teams in a fast-paced, high-pressure environment.
  • Strong organizational skills with the ability to manage multiple tasks effectively.
  • Familiarity with biopharmaceutical manufacturing processes, project management, and technical documentation.
  • Knowledge of upstream and/or downstream biopharmaceutical manufacturing practices.
  • Understanding of aseptic processing and in-process analytics for GMP manufacturing.
  • Proficient in technical writing and regulatory filing processes.
  • Skills to enhance the efficiency and integrity of routine GMP operations, including regulatory filing and project management.
  • Solid understanding of engineering principles related to cell culture, fluid transfer, and mixing.
  • Excellent mechanical aptitude and proficiency with MS Office applications.
  • Strong communication skills and the ability to work collaboratively in a team environment.
  • Flexibility to support a 24/7 GMP production facility.
  • Hybrid remote/on-site working arrangement.

Physical Requirements:

  • Ability to gown into a GMP facility.
  • Capacity to stand for extended periods as needed.
  • Able to lift up to 50 lbs.

Educational Background:

  • Bachelor's Degree in Biochemical Engineering or a related field, with a minimum of 6 years of relevant professional experience, or 10+ years of equivalent technical/design experience in large-scale biopharmaceutical manufacturing.

Compensation: $47-57/Hr; salary will be commensurate with experience.