(CW) Material Sciences Specialist Contract

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. 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. Onsite in Novato on Tuesday and Wednesday*** CONTRACT ROLE Position Summary: BioMarin is seeking a temporary contractor to support execution of a global material specification remediation program associated with regulatory commitments and CAPA activities. The contractor will work closely with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements. This role will provide critical support to accelerate regulatory commitments while enabling Material Sciences personnel to remain focused on strategic product and manufacturing priorities. The position will support specification updates, technical data gathering, compendial comparisons, document management, change control execution, and cross-functional implementation activities. ________________________________________ Key Responsibilities Specification Remediation • Review existing raw material specifications against current compendial requirements. • Compare USP, Ph. Eur., JP, ACS, and supplier specifications where applicable. • Support revision of excipient, chemical, and process material specifications. • Compile technical justification packages and supporting rationale for specification updates, where appropriate. Change Control & CAPA Support • Support initiation and execution of change controls related to specification updates. • Coordinate impact assessments from affected functional groups. • Track implementation progress and CAPA milestones. • Assist with closure documentation and inspection readiness activities. Data Management & Documentation • Maintain specification inventories and implementation trackers. • Generate summary reports and status dashboards. • Verify technical data consistency across specifications and supporting documents. • Ensure document formatting aligns with approved specification templates. Cross-Functional Coordination • Work with Material Sciences, Quality Systems, Quality Control, Regulatory Affairs, Supply Chain, Manufacturing, and Procurement. • Follow up with SMEs regarding impact assessments and outstanding actions. • Support meeting preparation and action item tracking. Inspection Readiness • Assemble supporting documentation for regulatory inspections and CAPA effectiveness reviews. • Support ongoing alignment of specifications with compendial and regulatory expectations. ________________________________________ Required Qualifications • BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline. • 3–4 years of experience in pharmaceutical manufacturing, quality, technical services, material sciences, or regulatory compliance. • Experience working with GMP documentation. • Strong technical writing and document revision skills. • Familiarity with change controls, CAPAs, and deviation systems. • Knowledge of pharmacopeial standards (USP, EP, JP). ________________________________________ Preferred Qualifications • Experience with raw material specifications and supplier quality systems. • Understanding of excipient and chemical control strategies. • Experience supporting regulatory inspections or remediation programs. • Familiarity with Veeva, document management systems, and electronic quality systems. • Ability to independently manage multiple workstreams and priorities. ________________________________________ Success Metrics • Specification revisions completed on schedule. • Change control support delivered to meet CAPA milestones. • Impact assessments and implementation activities tracked to completion. • Inspection-ready documentation maintained. 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. 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.