(CW) Manufacturing Associate (Temporary/Contract)

BioSpace; Novato (CA); On-site; USD 55,000 - 83,000; Part time

Job summary

BioMarin is seeking a contract role professional for a night shift (6:00 pm–7:00 am) in California. The incumbent will support biopharmaceutical manufacturing processes, learn automation systems, and contribute to process optimization and quality compliance within the Technical Operations group.

The role requires a science or engineering degree (or biotech-equivalent) and experience in regulated environments. It offers cross-functional collaboration and exposure to scale-up activities.

Qualifications

• Bachelor's degree in science-related field or engineering.
• Associate's degree in science-related field or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.

Responsibilities

• Process knowledge: understand process theory and equipment operation for mammalian cell culture and downstream processing; support process optimization.
• Technical documentation: provide feedback and update procedures; help implement new technologies and standards; write/review process documents.
• Quality and compliance: understand cGMPs related to Commercial Operations; use quality systems (Deviations, CAPAs, Change Requests, etc.).
• Business: participate in projects and learn/support new business systems; assist in tracking defined department metrics.

Skills

Communication

Teamwork

Initiative

Education

B.S. in science or engineering

Assoc. degree or biotech certificate + 2+ yrs experience

Job description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

CONTRACT ROLE SHIFT Schedule

The schedule will be from 6:00 pm to 7:00 am, with the first week covering Wednesday to Saturday, and the following week rotating to Wednesday to Friday. This means the schedule alternates each week between four and three nights.

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.

Skills

• 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

Education

• 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

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.

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.

Equal Opportunity Employer/Veterans/Disabled. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.