(CW) Manufacturing Associate DAY SHIFT (Temporary/Contract)

biomarin; Novato (CA); On-site; USD 60,000 - 95,000; Full time

Job summary

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. BioMarin’s Technical Operations group builds and maintains manufacturing processes, ensuring quality and regulatory compliance for clinical and commercial drug substances.

We are seeking candidates with a science or engineering background and hands-on experience in biotech manufacturing, ready to contribute to cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor’s degree in a science-related field 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

• Understand process theory and equipment operation; 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 process optimization initiatives; 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.
• Understand cGMPs as related to Commercial Operations; utilize quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Participate on projects and contribute to outcomes; learn and support new business systems (Track wise, ERP, etc.); support trending of defined department metrics.

Skills

Strong verbal communication

Strong written communication

Teamwork

Initiative

Education

Bachelor’s degree in science/engineering

Associate’s degree or biotech certificate + 2+ years experience

Tools

LIMS

MES

PI

TrackWise

ERP

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 such as achondroplasia, PKU, CLN2, Batten disease, and several forms of MPS, as well as Fabry disease and Pompe disease, offer new possibilities for patients and families who previously had few options.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating drugs for use in clinical trials and scaling production for the commercial market. Engineers, technicians, scientists, and support staff build and maintain cutting‑edge manufacturing processes and sites, provide quality assurance and control, procure goods and services, and coordinate the worldwide movement of our drugs to patients.

Schedule

Sun‑Tues/Alternating Wednesdays 6 AM to 7 PM.

Duties

• Process Knowledge: Understand process theory and equipment operation; 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 process optimization initiatives; 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: Understand cGMPs as related to Commercial Operations; utilize quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Business: Participate on projects and contribute to outcomes; learn and support new business systems (Track wise, ERP, etc.); support trending of defined department metrics.

Work Environment / Physical Demands

• Strenuous, repetitive work involving bending, reaching, climbing stairs and ladders, kneeling, and making numerous equipment connections using hands.
• Ability to regularly lift, dispense, push and/or pull items up to 25 pounds.
• Requires work around loud equipment and use of personal protective equipment.
• Requires various shift‑based work and off‑hours.

Skills

• Strong verbal and written communication skills.
• Teamworking with good conflict resolution and collaboration.
• Displays strong initiative to identify areas for improvement and implement solutions.

Education

• Bachelor’s degree in a science‑related area or engineering.
• Associate’s degree in a science‑related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.

Additional Information

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

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.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents, and participating in EHS initiatives and training.