New

Sr. Process Engineer I, Material Science

BioMarin Pharmaceutical Inc.
United States, California, Novato
Feb 06, 2025
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. Senior Process Engineer I, Material Science SUMMARY This position requires the utilization of expertise relevant to biopharmaceutical materials and processes with an emphasis on single use technologies (bags, filters, tubing assemblies, drug product materials) and may also include support of chemical raw materials (chemicals, media, resin). Technical expertise in biopharmaceutical manufacturing materials is required to provide support to Commercial and Clinical manufacturing operations as well as Process Development operations. This position requires a detailed knowledge and understanding of product-contacting materials, technologies, applications, andsuppliers. This position can also require knowledge of industry standards that govern chemical raw materials (compendia, etc.). Employee will assess and approve raw materials for use. Employee will lead, develop, and implement process improvement initiatives via evaluation of current raw materials, practices, process history, equipment, and technologies. He or she will support troubleshooting and investigations of existing processes by having a detailed understanding of the raw materials used. He or she will support transfer of new processes from Process Development into a cGMP Manufacturing environment. He or she will utilize existing methods and Quality Management System tools (Veeva) to implement new raw materials or processes, or to make changes to existing raw materials or processes. He or she should be detail oriented while also operating with a broad strategic perspective. RESPONSIBILITIES Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives and/or projects with an emphasis on single use items and technologies and chemical raw materials Assist in the development of site/company standard raw material platforms and business practices Assess raw material supplier change notifications, complaints, etc. Support investigations into raw material deviations and/or abnormal events and assess and approve subsequent corrective actions and/or changes Evaluate and/or test the feasibility of new manufacturing raw materials Participate in the execution of small-scale validation studies to establish a broad library of approved and/or accepted raw materials, vendors, etc. Responsible for technical evaluation of proposed raw material changes to Manufacturing processes Support technology and process transfer to and from the Manufacturing areas or facilities to ensure developing processes align with established large-scale and/or Commercial Manufacturing raw materials and practices Manage raw material change requests, CAPAs, and Action Items via Veeva QMS Support raw material business reviews, site visits, and supplier audits Oversee project milestones, departmental goals, and carry out strategic initiatives Communicate progress and status of projects clearly and effectively Create projects, spreadsheets, and presentations via Microsoft Office programs Continued education on understanding of raw materials and their governing bodies EXPERIENCE Required Skills: 5+ years of relevant industry experience in pharmaceutical or biopharmaceutical production 2+ years of relevant experience in a position utilizing formal project management with a proven track record of successfully leading, facilitating, managing, and delivering on cross-functional projects/initiatives Strong knowledge of and expertise of pharmaceutical raw materials (bags, filters, tubing assemblies, drug product materials, chemicals, media, resin) Established working relationship with raw material suppliers Basic understanding of biopharmaceutical processes and raw materials used to support manufacturing operations Strong technical understanding of general biopharmaceutical manufacturing processes and techniques (bioreactor operations, depth filtration, media/buffer preparation, etc.) Experienced in the transfer of processes and technology to cGMP and/or clinical operations Experienced in cGMP and with large-scale manufacturing equipment and practices Knowledge of chemical raw material standards (compendia, BioPhorum, etc.) Understanding of FDA and European regulatory requirements and guidelines Proven project management, organizational, and communication skills Proven ability to independently manage work, actions, and expectations Proven ability to handle multiple tasks concurrently and be flexible and adaptable Proven ability to meet deadlines Ability to speak to, present information/data to, and gather consensus/buy-in from a variety of audiences/stakeholders Experience with electronic quality management systems such as TrackWise, LIMS, Veeva, etc. Strong knowledge of and experience using Microsoft Office programs (Project, Excel, PowerPoint) EDUCATION BS in Life Sciences with 5+ years of relevant experience or MS with 2+ years of relevant experience in Manufacturing Sciences and Technology, Process Development, cGMP Manufacturing, or supporting department CONTACTS This position involves close collaboration with several key groups within Technical Operations including, but not limited to, Clinical and Commercial Manufacturing, Process Development, Drug Substance Technologies (Technology Transfer, Process Validation, Product Technical Owners, Process Stewards), Drug Product and Device Technologies, Material Operations, Product Supply Chain, Global Sourcing and Procurement, Global Supplier Quality, Quality Assurance (Validation, Operations, Raw Materials), Quality Control Raw Materials, Compliance, and Regulatory Affairs. SHIFT DETAILS Monday-Friday, 8:00 am-5:00 pm, salaried position ONSITE, REMOTE, OR FLEXIBLE Flexible role requiring employee to be onsite 2-3 days per week TRAVEL REQUIRED Periodic travel may be required to attend relevant professional conferences, workshops, or trainings, support technical transfer, and/or evaluate systems, processes, and technologies. 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. 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. In the U.S., the salary range for this position is $ 116,000 to $ 174,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.