(CW) Manufacturing Associate

BioMarin Pharmaceutical Inc.•Novato, CA

2d•Onsite

About The Position

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. CONTRACT ONSITE Sunday-Tuesday/alternating Saturdays 1800-0700=6PM to 7AM Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to 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. WORK ENVIRONMENT/PHYSICAL DEMANDS • Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. • Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. • May require work around loud equipment. • The use of personal protective equipment will be required. • Requires various shift based work and off hours. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Requirements

Strong communication skills—verbal and written
Ability to work in a team environment which includes good conflict resolution and collaboration
Displays good initiative to identify areas for improvement and implement solutions
Bachelor’s degree in science related area or engineering
Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

Responsibilities

Understanding of process theory and equipment operation.
Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance.
Support initiatives for process optimization.
Identify and elevate processing issues and support solutions.
Gain experience with automation systems (LIMS, MES, PI, etc.).
Provide feedback and/or suggested changes to operational procedures.
Assist in the incorporation of new technologies, practices, and standards into procedures.
Capable of writing and reviewing process documents.
Understanding of cGMPs as related to Commercial Operations.
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
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.