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Principal Engineer - Drug Product
Technology Transfer - Novato / Hybrid
Technical Development Services (TDS)
are hiring for
a Principal Engineer Drug Product Technology Transfer (Sterile)
with the following remit.
*
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
.
*
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.
*
D
evelopment and implementation of Tech Transfer best practices and standardisation across the
Internal and
external manufacturing network.
*
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.
*
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.
*
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.
*
10+ years of professional experience in the pharmaceutical industry, including managerial experience.
*
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:
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Degree in Engineering, Science or Business Discipline
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PhD / master's in science or engineering Discipline is preferable.
Location
* East Coast US
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Travel:
15
-
25
% |
BioMarin Pharmaceutical Inc.
life insurance, paid time off
May 15, 2025