Scientist 2, Chemical Development & Manufacturing
Company: BIOMARIN
Location: Novato
Posted on: November 17, 2023
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Job Description:
Who We Are 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. Summary:The Chemical Drug Product Device
Technology (CPDT) group, which is part of the Technical Development
organization, seeks an experienced scientist to manage external
synthetic chemistry and manufacturing efforts, in support of
pre-clinical and clinical programs. These programs span a range of
modalities (traditional small molecules, peptides, and polymers
with an emphasis on Oligonucleotides) produced at contract
manufacturing organizations (CMOs) operating under non-cGMP or cGMP
requirements, as appropriate.The role provides day-to-day oversight
and tactical management for synthetic molecule, drug substance
contract manufacturing activities, especially during clinical
development. As such, handovers from the Research and Early
Development organization and ultimately, transfer to Global
External Operations, will be central.Project management,
implementation and tracking of Electronic Business Systems, cGMP
document management and tracking, coordination with contractors and
interfacing internal functions, including Research and Early
Development, Global External Operations, Quality, Legal, Finance,
Supply Chain and Regulatory Affairs CMC, will largely drive day to
day activities. Furthermore, as part of the CPDT group, the
successful applicant will strongly connect with the Drug Product
Development and Analytical Sciences teams.The position will also
serve person-in-the-plant responsibilities, for both critical and
routine production activities and will involve interaction with
contractor technical staff, for the development, optimization of
chemical processes and real-time manufacturing oversight.
Responsibilities:--- Through cross functional team engagement,
establish and monitor program and project timelines, maintaining
tight coordination with interfacing functions, to ensure continued,
on time supply of drug substance, through alignment with clinical
development milestones.--- Assimilate technical details (synthetic
and analytical) regarding early-stage processes so as to draft
effective Requests for Proposals (RFPs) to be submitted to
potential CMOs.--- Help identify process improvements, coordinate
transfer and implementation of those changes and monitor ongoing
improvements at the contractor sites, to ensure consolidation.---
Communicate and coordinate internal evaluation of process changes,
change requests, deviations, and OOS findings. Coordinate with BMRN
and contractor quality groups to ensure timely evaluation and
approval of master and executed batch records, as well as other
cGMP documents. Create justifications for changes, which would
typically be driven by cost-of-goods, product quality, streamlined
procedures and/or logistical simplicity.--- Coordinate with
contractor and BMRN quality and regulatory personnel to support
regulatory submissions, to implement new procedures.--- Manage
technology transfer activities to and between contractor sites,
encompassing process, analytical and logistical aspects.--- Acquire
and share knowledge of the contract manufacturing landscape,
through interaction with candidate organizations, speculative site
visits and attendance at trade shows.--- Serve as Person-in-Plant
as needed for manufacturing campaigns, providing real-time
manufacturing oversight on both synthetic and analytical aspects of
assigned programs. Participate in cGMP compliance audits, as a
technical subject matter expert.--- Develop tight working
relationships with Research and Early Development and Global
External Operations colleagues, developing handover strategies and
ensuring periodic internal information sharing.--- Drive innovation
and new technology, sharing information frequently, at CPDT and
wider communication platforms. Remain up to date with academic and
industrial advances, through networking, literature familiarity and
conference attendance. Scope:This position touches on the full
range of BioMarin's synthetic molecule activities, including (but
not limited to): production of drug substances under cGMP
conditions; production of non-GMP regulatory starting materials;
evaluation of chemistry for process and research improvements;
identification and evaluation of chemical suppliers. The primary
focus of the role covers both tactical and strategic aspects of
clinical contract manufacturing. Education:PhD level in Chemistry
or Chemical Engineering. Post-doctoral experience would be an
advantage. Bachelors, Masters level candidates will also be
considered, depending on academic and industrial experience.
Business, leadership training or related training credentials,
would be desirable. Experience:--- A minimum of 4 years of related
experience is required in synthetic molecule, drug substance
operations, in either manufacturing or R&D environments.
Experience in Antisense Oligonucleotide (ASO) development and/or
manufacture, would be an advantage.--- Solid understanding of
routine analytical methods.--- Familiarity and/or working with ERP
and Veeva documentation systems are desirable, but not required.---
Working knowledge of process engineering and/or organic chemistry,
at both the research level and in large-scale GMP production, is
desirable. Working knowledge of pharmaceutical regulatory
requirements, appropriate to level and solid cGMP is desirable but
not required.--- Excellent written and oral communication skills;
expectation to present frequently, at in house forums.--- Ability
to assimilate, filter, and assemble technical information from a
variety of sources to glean an understanding of assigned
projects--- Must be willing to work on multiple projects
Environment:A suitable BioMarin office space will be assigned.
Flexibility to work from home, for some of the time, will also be
accommodated. Travel: 10 - 20%. This would arise from time spent on
American/ European contractor sites, BMRN facilities, such as those
in Marin County and Ireland, as well as possible visits to raw
material suppliers in Asia. Equipment:Standard IT equipment, such
as laptop and accessories. Contacts:Internally, this person will
frequently interact with Research and Early Development, Global
External Operations, Quality, Legal, Finance, Supply Chain and
Regulatory Affairs CMC, as well as other functions. As an active
member of the CPDT group and the Technical Development
organization, connections with the Drug Product Development team,
Analytical Sciences and the various MSAT functions, will be
frequent.He/she will also be one of the main contacts for clinical
synthetic molecule CMO (Contract Manufacturing Organizations) work
and contracts. We are an equal opportunity employer and all
qualified applicants will receive consideration for employment
without regard to race, color, religion, gender, gender identity,
sexual orientation, national origin, disability status, protected
veteran status, or any other characteristic protected by law. In
the U.S., the salary range for this position is $ 112,000 to $
168,000 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.
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Keywords: BIOMARIN, Novato , Scientist 2, Chemical Development & Manufacturing, Accounting, Auditing , Novato, California
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