Associate, Manufacturing (Night Shift)

About the role

The Manufacturing Associate, Novato position within BioMarin's Technical Operations group is responsible for developing and scaling drug production for both clinical trials and commercial markets. This role involves establishing and maintaining innovative manufacturing processes and facilities, ensuring quality assurance and compliance with regulatory standards, and managing the global distribution of BioMarin's drugs.

Responsibilities

• PROCESS KNOWLEDGE:
  • Understanding of process theory and equipment operation
  • Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
  • Support initiatives for process optimization
  • Identify and elevate processing issues and support solutions
  • Demonstrated experience with automation systems (LIMS, MES, PI, etc.)
• TECHNICAL DOCUMENTATION:
  • Provide feedback and/or suggested changes to operational procedures
  • Absorb and incorporate new technologies, practices and standards into procedures
  • Capable of writing and reviewing process documents
• QUALITY AND COMPLIANCE:
  • Understanding of cGMPs as related to Clinical and/or Commercial Operations
  • Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
• BUSINESS:
  • Ability to participate on projects and contribute to outcomes
  • Capability to learn and support new business systems (Track wise, ERP, etc.)
  • Support trending of defined department metrics

Requirements

Minimum qualifications include a bachelor's degree in a relevant field such as Biotechnology, Chemical Engineering, Microbiology, or a related discipline, and at least 2 years of experience in biopharmaceutical manufacturing or related fields. Experience with automation systems, knowledge of cGMPs, and strong communication skills are preferred.

Qualifications

Must possess a valid driver’s license and reliable transportation. Must be able to work flexible hours, including occasional weekends and holidays.

Skills

Strong problem-solving skills, attention to detail, and the ability to work independently and as part of a team are essential. Proficiency in Microsoft Office applications and familiarity with quality management systems are also required.

Benefits

Comprehensive benefits package including medical, dental, vision, retirement plans, paid time off, and more.

Pay

Competitive salary commensurate with experience.

Schedule

Backhalf Graves, Wed-Friday alternating Saturday 6pm-7am