Principal Engineer, Drug Product [East Coast]
 BioMarin Pharmaceutical Inc. | |
life insurance, paid time off
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 United States, California, San Rafael | |
| 770 Lindaro St (Show on map) | |
 Jul 08, 2025 | |
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Who We Are Principal Engineer - Drug Product
Technology Transfer
Technical Development Services (TDS)
are hiring for
a Principal Engineer Drug Product Technology Transfer (Sterile)
with the following remit.
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Provide technical and scientific leadership to the
Drug Product Internal and External manufacturing network
through partnerships with global functions and third-party Commercial Manufacturing Organisation's (CMOs) to introduce new products and technologies
.
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Lead Complex Drug Product Tech Transfer programs internally and externally.
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Accountable for delivery of successful process characterisation, engineering, process performance and support to regulatory filing
for drug product.
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Driving excellence in Tech Transfer execution for Sterile Drug Product
.
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Serve as the Drug Product representative on Global Drug Product Partner Teams for selected products.
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D
evelopment and implementation of Tech Transfer best practices and standardisation across the
Internal and
external manufacturing network.
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Successful delivery of the product development pipeline and commercialisation strategy.
The role will combine scientific, engineering, and operational leadership. This position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes.
Duties:
Leadership:
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Manage and communicate the key project portfolio milestones to key stakeholders.
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Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions.
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Ability to lead, collaborate and motivate cross functional and matrix teams.
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Serve as a key member of the Global Drug Product Technology Transfer team providing expertise and guidance across internal and external network.
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Partner with
Drug Product and Packaging Development
leadership to provide technical expertise and discussion during GMP audits from regulatory authorities.
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Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
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Participate in Global Partner Teams and CMC team as required.
Skills:
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Experience in the Biopharma, experience in Process Development and MSAT
/ Technical Development
organizations is desirable.
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10+ years of professional experience in the pharmaceutical industry, including managerial experience.
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A broad understanding of Drug Product
and a keen sense of business acumen.
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Experience collaborating effectively with other functional groups to achieve business objectives.
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Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
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Demonstrated initiative; results oriented, initiative to institute change.
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Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
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Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
Education: Degree in Engineering, Science or Business Discipline PhD / master's in science or engineering Discipline is preferable. Location
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. For additional benefits information, visit: https://careers.biomarin.com/benefits.
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