Sr. Manager, Drug Product and Device Technologies
BioMarin Pharmaceutical Inc.About the role
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.
BioMarin is seeking a highly motivated individual with drug product and process development experience to oversee commercial and clinical manufacturing of existing products, and lead process development & technology transfer for drug products in the pipeline. In addition, the individual is expected to lead drug product partner team comprising of various cross functional members, along with overall process development, scale-up and PPQ batches manufacturing activities, including regulatory filing support as needed. Small molecule oral drug product experience is preferred. The individual hired in this position will be a part of DPDT (Drug Product & Device Technologies) organization and will be interacting with various internal cross-functional team members such as Global operations, Quality, DS (Drug Substance) Manufacturing, Analytical, Packaging and Engineering, and the members from external CMOs (Contract Manufacturing Organizations) and other relevant cross functional teams on as needed basis. The scope of the individual includes product development, including commercial technical support. The individual will also be responsible for developing a robust, reproducible, scalable, and validatable formulation and manufacturing process, and providing technical support for shipping qualification. Other responsibilities include but not limited to phase appropriate formulation and process development and optimization, person-in-plant support as needed through clinical and commercial DP manufacturing, provide technical input and support to Global Ops as needed during commercial manufacturing. Routine reporting of activities, issues, strategy, risks, etc. to the management is expected. The individual serves as a scientific monitor for formulation development, technology transfer and manufacturing at CDMOs (Contract Development and Manufacturing Organizations). The role involves making use of scientific expertise and understanding of the industry, to develop and contribute to complex company objectives. Knowledge of GMP (Good Manufacturing Practice) is preferred. Scope and Responsibilities
- 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 technic
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