Sr. Manager, Analytical Services
Location: Novato
Posted on: June 23, 2025
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Job 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. 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. Job Summary The Sr. Manager,
Analytical Services is a leadership position in the Analytical
Sciences team, focused on leading a team of Scientists, Research
Associates and Analysts in development, optimization, validation,
transfer and troubleshooting of analytical test methods for new and
existing products throughout lifecycle of analytical test methods.
The Senior Manager is also accountable for maintaining an
inspection ready laboratory. KEY RESPONSIBILITIES Department
Leadership and Management Collaborate with AS Functional Head and
People Department to identify needs and participate in recruiting,
hiring, and promoting staff Lead and develop a cohesive, balanced,
and high functioning team focused on producing high quality
deliverables and outcomes Optimize the organizational design and
allocation of team resources across the Technical Lab Operations to
meet the needs of a growing pipeline of products as well as
critical non-program strategies and initiatives Mentor, coach and
inspire Analytical Services team on BioMarin skill and career
development Ensure all individual training and guidelines are kept
current. Set short- and long-term Analytical Services department
goals oriented to a high performing Analytical Services function
(e.g., Objectives and Key Results (OKRs)) Manage annual budget,
operational expenditures, and forecasting activities Lab
Operations, Method Development, Optimization, Validation and
Transfer Oversee/Manage the development, validation, and transfer
of analytical/bioanalytical methods used in BioMarin’s clinical and
commercial testing operations and process development labs Delegate
responsibilities of laboratory equipment qualification and
maintenance, where applicable Write/Review protocols, experimental
designs to support clear instructions for implementation /
execution of experiments Design and execution of special studies
for product development activities Manage and perform activities
associated with validation and transfer of QC Methods used to
support BioMarin’s programs including, but not limited to, to
Contract Testing Organizations (CTOs), In-Country Test Labs and
strategic partners Provide technical expertise for analytical
methods in QC, including training when required Support the
maintenance and management of method and analytical equipment
performance Troubleshoot and develop the plan for optimization of
analytical methods Review and approve documents such as, but not
limited to, Quality Control standard operating procedures, method
validation, verification, transfer protocols, protocols, reports
and TrackWise records Review analysis and trends, for quality
control non-routine data Analyze and review QC Laboratory
investigations for trends to support assessments that affect assay
life cycle management Provide technical support to Manufacturing,
Quality and QC during manufacturing and/or QC investigations, when
required Regulatory Compliance, Audit and Site Support Ensure the
laboratory in an inspection-ready state and that all Analytical
Services staff take part in maintaining the lab in an inspection
ready state Provide technical support for site and product related
inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP
inspections) Interpret and apply 21CFR, USP, EP, JP and ICH
regulatory guidelines and directives Interact directly with
regulatory agency inspectors during audits Prepare and review
documentation to cGMP standards – often for direct submission to
pharmaceutical regulatory agencies Ensure the team is compliant to
GxP and safety and environmental standards Process Improvement and
Training Support the implementation and management of GxP method
training within Analytical Services Support improvement activities
to ensure delivery of scientifically sound and efficient QC methods
Support or lead continuous improvement in quality systems
(procedures and systems) to improve organizational effectiveness,
quality assurance compliance, and regulatory and other requirements
(cGMP, ICH) SKILLS AND EXPERIENCE Method Development, Optimization,
Validation, Transfer, and Lifecycle Management Expertise in
biochemical techniques such as enzymatic activity, enzyme kinetics,
and cell-based method. Excellent people development skills and team
leadership Excellent communication and stakeholder management
skills Organizational skills and and aptitude for developing robust
processes to improve efficiency in the labs Experience leading
teams through organizational change Process Development and/or
Manufacturing science experience preferred Experience supporting
CMC teams preferred EDUCATION: B.S 10 years experience, MS 8 years
experience, or PhD 3-5 years experience 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.
Keywords: , Gilroy , Sr. Manager, Analytical Services, Science, Research & Development , Novato, California
