Manager, Contract Manufacturing
Company: BioMarin Pharmaceutical Inc.
Location: Novato
Posted on: June 20, 2022
Job Description:
BioMarin is the world leader in delivering therapeutics that
provide meaningful advances to patients who live with serious and
life-threatening rare genetic diseases. We target diseases that
lack effective therapies and affect relatively small numbers of
patients, many of whom are children. These conditions are often
inherited, difficult to diagnose, progressively debilitating and
have few, if any, treatment options. BioMarin will continue to
focus on advancing therapies that are the first or best of their
kind.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. Come join our team and make a meaningful
impact on patients' lives.SUMMARY:The Chemical, Drug Product and
Devices Technologies (CPDT) group, which is under the Technical
Development organization, contributes to and aligns with BioMarin'
s mission of developing and commercializing innovative
biopharmaceuticals for serious diseases and medical conditions. The
CPDT group leads the development of stable, reproducible, and
scalable drug products and devices that are safe for non-clinical,
clinical, and commercial use. Additionally, CPDT aims to ensure an
end-to-end chemical and manufacturing processes development for
small molecules and oligonucleotides drug substances. In addition
to in-house product development, CPDT also engages in collaborative
partnership with contract manufacturing organizations (CMOs) to
expedite development of selected drug product
candidates.Responsibilities:This individual contributor will work
in the CPDT group to assist in the advancement of BioMarin' s
therapeutics for clinical evaluation and potential
commercialization. In collaboration with a cross functional teams,
key stakeholders as well as external partners, the individual will
establish, monitor, and manage project milestones while ensuring
compliance with BioMarin' s quality standards. As the role cuts
across formulation and device development, working knowledge of
manufacturing and fill finish processes for small molecules,
biologics, oligonucleotides and or gene therapy drug products is
ideal.The position requires the following core
competencies:---Understanding of quality systems and GMP
processes---Working knowledge of drug product development
process---Project management expertise---Organizational and
communication skills ---Negotiation and influencing
skillsAdditionally this individual will:
- Facilitate selection, establishment, maintenance and
decommissioning of strategic CMO partners
- Assist with contract and QTA negotiations as well as compliance
audits
- Provide quality oversight for outsourced manufacturing,
testing, packaging, and release procedures/activities
- Review and approval of Master and executed batch records as
well as other GMP documents
- Ensure projects are executed in alignment with BioMarin's
quality standards and manage their timely completion
- Work with subject matter experts to support the
design/review/approval of development study documents (i.e.
prototype screening, characterization, stability, fill-finish
compatibility etc.)
- Manage technology transfer activities to and between contractor
sites, encompassing process, analytical and logistical aspects
- Evaluate contract manufacturing organization for fit with
BioMarin development project requirements by leveraging knowledge
on contractors' landscape through interaction with candidate
organizations, site visits and attendance at trade shows.
- Coordinate assessments of process changes, change requests,
deviation and out of specification findings
- Ensure quality issues are investigated and appropriate
corrective actions are implemented
- Prepare and deliver effective oral presentations at relevant
department and cross functional meetings
- Manage change requests, deviations, CAPAs on TrackWise
- Manage CMO meetings and project directory
- Provide Person in Plant (PIP) oversight for clinical CMOs, as
needed
- Interact with various internal and external organizations.
- Engage with members of Chemical, Drug Product and Device
Technologies, Analytical Sciences, Legal, Supply Chain, Clinical
Operations, Global External Operations, Quality Control,
Manufacturing, Regulatory, and Contract Manufacturing, Purchasing
groups to jointly advance compounds through product development
process.
- Interact with external parties (CMOs, contract laboratories,
equipment Vendors, excipient suppliers etc.)Requirements:
- Manager: 4+ years of experience (2+ years with Masters) with
> 2 years of supervisory role in pharmaceutical or biotech
setting.
- Sr. Manager: 6+ years of experience (4+ years with Masters)
with > 2years of supervisory role in pharmaceutical or biotech
setting.
- Experience managing a lab, preferred.
- Able to work at the Novato, CA site a minimum of 2 days a
week.
- Excellent interpersonal, verbal, and written communication
skills
- Strategic/critical thinking and problem-solving skills
- Understanding of drug product development and GMP
processes
- Ability to facilitate meetings, take accurate notes and
communicate commitments
- Work collaboratively and effectively in cross-functional
teams
- People management skills-efficiently leverage resources to meet
project milestones
- Proficient with MS Word, Excel, and PowerPoint
- Experience with managing quality investigations
- Strong leadership and PO generation and accrual
management.
- Technical expertise in drug product and device development,
preferred.
- Knowledge of risk management tools as Fishbone, Failure Mode
Effects Analysis, etc, preferred.
- Experience with oversight of phase appropriate GMP requirements
during early phase development, preferred.
- Proficiency with eQMS (TrackWise) and eCDMS (Veeva) is
preferred
- Experience establishing best practice processes, a plusPLEASE
NOTE: Absent a Medical or Religious reason that prohibits
vaccinations, all our incoming employees must be vaccinated for
COVID-19.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.
Keywords: BioMarin Pharmaceutical Inc., Novato , Manager, Contract Manufacturing, Executive , Novato, California
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