Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

Our Culture

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.

• E2E drug product development, including commercial technical support.
• Phase appropriate formulation and process development, optimization, and characterization studies.
• Plans experimental design and strategic planning of drug product formulation development throughout the non-clinical, clinical, and commercial phases.
• Technology transfers to external drug product manufacturing facilities.

• Deliver pre-PPQ FMEA and/or NOR/PAR range finding efforts, along with any other characterization, including registration and PPQ.
• Manage drug product (DP) technical and manufacturing risks and propose mitigations as appropriate, during commercial manufacturing.
• Provide Person-In-Plant (Pip) support as needed through clinical and commercial DP manufacturing, including resolving technical issues and/or managing deviations that arise during manufacturing.
• Provide technical input and support to CDMO (Contract Development and Manufacturing Organization) Ops Management team in development (CDMO) & manufacturing (CMO) site selection assessments from Tox to pre-pivotal phase, including GMP DP manufacturing.
• Provide technical input and support GEO (Global External Operations) (as appropriate) in manufacturing (CMO) site selection assessments from pivotal to commercial stage of DP manufacturing.
• Collaborates in a matrix organization with Research, Process Development, Quality Assurance, Quality Control, Analytical Chemistry, Packaging, Supply chain, and Regulatory Affairs to deliver project objectives.
• Provides scientific guidance and consultation to junior scientists on experimental designs, trouble shooting, data interpretation and technical challenges.
• Develops conceptual designs and experiments to solve technical issues.
• Leads the development and optimization of drug product formulations.
• Has a clear understanding of experimental results and provides recommendations to commercial process teams based on input from CMOs.
• Accountable for creating, maintaining, and updating status of scheduled activities/milestones to the management in appropriate forums.
• Support new CDMO selection and CDMO site due diligence evaluations and visits
• Provides feedback on study protocols, development reports and manufacturing batch records to support formulation development, technology transfer or manufacturing at CMOs or CDMOs.
• Provides updates of project status, risks, and mitigation strategies in the context of overall program goals.
• Reviews authored technical reports, contributes to regulatory submission documents.
• Contributes to the overall strategy, performance, and direction of Drug Product and Device Technologies function.
• Perform financial analysis to support new or revised project proposals.
• Oversight of project controls and budgeting.

• Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team, to bring about the successful planning, monitoring, and executing of deliverables.
• Experience with small molecule oral solid dosage form is preferred.
• Experience working with CMOs is highly preferred.
• Experience with designing formulation screening and optimization studies, and commercial manufacturing, specifically in oral drug product development is preferred.
• Experience with drug product formulation development, characterization, testing, quality risk assessment and CMC (Chemistry, Manufacturing, and Controls) regulatory guidance and filings.
• Strong leadership and team management skills. An ardent team player with good collaborative and people skills.
• Strong organization and prioritization skills, ability to facilitate and drive program forward
• Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
• The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.
• Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.
• Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.

• Operational knowledge of various processing techniques (wet/dry granulation, blending compression, coating, spray drying - preferred) and experience with small molecule drug products scale-up and technology transfer is preferred.
• Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC (RP-HPLC), DSC, TGA, DVS, XRPD, UV spectrophotometry, particle size measurement techniques such as DLS, and so on.
• Knowledge of drug product processing and packaging.

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.