Manufacturing Associate Ii Jobs in Santa Rosa, CA

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.
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.
Research Associate 2 - Critical Reagent Inventory Management (CRIM)
Department: Analytical Sciences (AS) - Systems & Operations (S&O), CRIM team
Reports To: Director, S&O
Worker Type: Full-time employee (FTE)
Location: Novato, CA (on-site presence, 5 days per week, required for laboratory and inventory operations)
SUMMARY
The AS S&O team is seeking a highly organized and proactive Research Associate 2 to own CRIM activities across AS. You will ensure critical reagents and reference standards (CR/RS) are available to support analytical testing throughout the product lifecycle - managing inventory, logistics, and storage on-site while supporting contract administration, documentation compliance, and operational planning.
This position will also support general contract management for the AS department, including CRIM contract management, to ensure the supply and quality of materials.
You will partner closely with AS laboratories, Supply Chain, Procurement, and external vendors to ensure material supply, replenishment, inventory management, and logistics keep CR/RS well supplied to AS testing labs in support of development programs. You will engage the Quality organization when CR/RS ownership transfers to Quality.
RESPONSIBILITIES
Inventory Management & Operational Planning

• Support replenishment planning to ensure availability of critical reagents through effective planning and forecasting.
• Conduct risk assessments for critical reagents to ensure operational continuity.
• Monitor urgent needs across AS and respond quickly to prevent testing interruptions.
• Conduct freezer mapping, cataloging, and storage organization for optimized on-site storage.

Execution & Material Logistics

• Perform on-site receipt, handling, and movement of CR/RS and laboratory samples.
• Register samples and inventory in the data management system (e.g., Benchling).
• Coordinate and fulfill shipment requests for CR/RS, laboratory samples, and other laboratory materials, as requested.
• Coordinate with laboratory teams, Supply Chain, and Procurement to keep materials flowing to testing groups.
• Support the transfer of CR/RS to the Quality organization as programs progress.

Contract & Vendor Management

• Perform contract management for AS, including service contract discussions, contract initiation, drafting scopes of work (SOWs), and vendor administration.
• Track contract status end-to-end and support business operations processes in partnership with the Project Management & Operations (PM&Op) function.
• Maintain documentation and records associated with external vendors and service providers.

Report Drafting & Quality Management System (QMS) Documentation

• Draft CR/RS reports and supporting documentation, including change records, change actions, and follow-up activities.
• Own Veeva and QMS documentation processes for CRIM, ensuring records are accurate, current, and compliant.
• Ensure activities comply with applicable Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and company procedures.

Leadership Responsibility

• This is an individual contributor role with no direct reports. You will coordinate cross-functional activities and may guide or train colleagues on CRIM processes and documentation.

Responsibilities may evolve based on business needs; flexibility and adaptability to take on additional or shifting priorities are expected.
EXPERIENCE
Required Skills:
Minimum of 3-5 years of industry experience (biotechnology, pharmaceutical, or laboratory environment), including experience in similar laboratory operations, inventory management, or CRIM-related role.

• Experience in laboratory operations, inventory management, quality systems, or analytical sciences.
• Good understanding of critical reagents and reference standards with the ability to serve as the single point of contact (SPOC) for CRIM.
• Strong organizational and documentation skills with the ability to manage multiple priorities.
• Ability to work on-site (5 days per week) to perform hands-on material handling and storage activities.
• Ability to work independently, proactively identifying opportunities and taking action.
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment, with the ability to work with ambiguity and complexity.
• Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.

Desired Skills:
5+ years of industry experience, including 2-3 years in a similar CRIM, laboratory operations, or inventory management role.

• Experience with GMP, GLP, or other regulated environments.
• Experience with Veeva, QMS records, or change control processes.
• Experience supporting contract administration or vendor management.
• Experience with inventory management systems and reagent/reference standard lifecycle management.
• Experience in pharmaceutical or biotechnology development environments.

EDUCATION
Minimum: Bachelor's degree in biology, chemistry, biochemistry, biotechnology, or a related scientific discipline, or equivalent experience.
Preferred: Bachelor's degree in biology, chemistry, biochemistry, or biotechnology; additional training or certification in inventory/supply chain management and/or experience in GMP/GLP environments is a plus.
CONTACTS
Reports To: Director, S&O
Internal: AS laboratories, Supply Chain, Procurement, Quality organization, and the Project Management & Operations (PM&Op) function
External: Vendors and service providers
SHIFT DETAILS
Full-time employee (FTE), 5 days per week. Occasional schedule flexibility may be needed to support urgent material receipt, storage, or shipment activities.
ONSITE, REMOTE, OR FLEXIBLE
Full-time onsite in Novato, CA, is required for laboratory and inventory operations.
TRAVEL REQUIRED
None to minimal (0-5%). Occasional local travel to company or vendor sites or offsite storage locations may be required.
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.