(CW) Manufacturing Associate (Temporary/Contract)

BioMarin Pharmaceutical Inc.; Novato (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking candidates for an onsite day shift position in Novato, CA.

The role focuses on operating and supporting biopharmaceutical manufacturing processes, with emphasis on process knowledge, documentation, and quality/compliance within a regulated environment. Ideal candidates will have a science or engineering degree (or biotech certificate with experience) and the ability to work in a team, learn new systems, and contribute to continuous improvement.

Qualifications

• 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

• Understand and operate biopharmaceutical manufacturing processes (mammalian cell culture, depth filtration, tangential flow filtration, chromatography, centrifugation, purification, and formulation).
• Support process optimization, identify issues, and assist in solutions; gain experience with automation systems (LIMS, MES, PI).
• Provide feedback on procedures and help incorporate new technologies and standards into procedures; write and review process documents.
• Support quality systems (cGMPs, Deviations, CAPAs, Change Requests, Action/Alert Reports) and participate in project work with cross-functional teams.

Skills

Communication skills

Teamwork

Initiative for improvement

Education

Bachelor’s degree in science or engineering

Associate’s degree in science or biotech certificate with 2+ years experience

Job description

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.

Onsite Day Shift 6am to 7pm

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.

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.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email [e-mail] with your request. This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team – please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at [e-mail] . Applicants, please do not use this email address to submit resumes – if you do so, you will be redirected to apply through the website.