Senior Manager, MSAT - Upstream Lead
Company: AGC Biologics
Location: Boulder
Posted on: June 20, 2022
Job Description:
AGC Biologics is a leading global Contract Development and
Manufacturing Organization, with a deep commitment to improving
life quality by bringing new biopharmaceuticals to market. Because
of our dedication to building and empowering our internal teams,
AGC Biologics is an innovative leader in the industry with an
extensive network of cGMP facilities in the US, Europe and Asia. As
such, we deliver a deep expertise, dynamic solutions and
technologies, as well as customized services for the scale-up and
cGMP manufacturing of protein-based therapeutics. We forge
exceptionally strong partnerships with our clients, and we never
lose sight of our pledge to deliver a reliable and compliant drug
substance supply, Right, On time. For more information, visit
www.agcbio.com.SummaryWe have an opportunity for a Senior Manager
of Upstream Tech Transfer to join the Manufacturing Science and
Technology (MSAT) team at AGC Biologics. This team member will lead
the effort of Technology Transfer activities with a product
lifecycle concept for manufacturing process. This is a key
leadership position in the MSAT team that is responsible for
process transfers and technology implementation throughput the
product life cycle for our product portfolio. The MSAT team is
responsible for the transfer, validation, manufacturing support,
and implementation of new processes, technologies and systems used
in GMP operations.Principal Responsibilities Include
- Directs and controls activities of the department including all
people management activities such as establishment of strategic
plan, effective delivery of objectives and KPI, project resourcing,
mentoring, training, goal setting, and performance evaluation. Also
develops and improves the efficiency of the department by setting
up the department structure and updating procedures to meet the
needs of the clients.
- Design and lead execution of risk assessments that are
compliant with company's validation program and aligned with
industry's best practices.
- Review/author relevant technical sections of regulatory dossier
or other communications to health authorities, as well as, provide
leadership in support of inspections/audits.
- Act as Investigation Lead in deviation investigations and
change control.
- Act as Technical lead in leading team to transfer processes and
technologies from Process Development to Manufacturing, in
accordance with Tech Transfer Plan and New Product
Introduction.
- As subject matter expert (SME), participate in project
evaluations against technical requirements, as well as, leadership/
representation in CMC-related governance meetings. May support
Business Develop for potential client presentations and proposal
generation.
- Improve alignment of Technology Transfer activities globally,
together with MSAT leaders at our other sites.
- Interface with the project teams to support product life cycle
change management projects, including drive long-term process
improvements execution.
- Provide technical leadership to Manufacturing and other
departments associated with GMP operations.
- Lead MSAT team in supporting manufacturing when troubleshooting
processes on the manufacturing floor and during post-operational
investigations
- Participate in the project team meetings, decisions, and
creation of milestones representing MSAT.
- Manage the Upstream MSAT team.
- Lead cross-site initiatives, ensuring seamless
cross-organizational interactions.
- The position offer interaction with a large number of internal
stakeholders, and is unique in having contact with both our
customers and all internal departments involved in process
development and manufacturing. You will be introduced to
biopharmaceutical companies globally and be an active player in
their projects.Knowledge, Skills And Abilities
- Experience mentoring and developing high performing teams.
- Must be self-motivated, organized and proactive.
- Ability to work on complex issues where analysis of situations
or data requires in depth knowledge of the company objective.
- Demonstrated ability to interface/communicate extensively with
internal and external clients, including senior management on
matters concerning several functional areas, divisions, and/or
customers.
- Ability to coordinate multi-departmental tasks and deliverables
(interaction with Business Development, Process Development,
Manufacturing, Engineering, Quality, etc.).
- Proven experience successfully managing multiple projects
simultaneously.
- Prior experience managing technical staff in a GMP
environment
- Demonstrated ability to build effective working relationships
across departments (QA, Process Development, Project Management and
Business Development) to support new processes and products.
- Demonstrated experience leading troubleshooting efforts.
- Strong communication skills necessary to interact with internal
and external stakeholders, with an ability to obtain buy-in from
all key stakeholders.
- Strong presentation skills.
- Strong driver of interdepartmental tasks with the ability to
keep the end goal in mind and prioritize between many different
tasks.Education / Experience
- Bachelor's Degree in Engineering or Science-related field with
8+ years of industry experience, or
- Master's degree with 6+ years of industry experience.
Equivalent education and experience may substitute for stated
requirements.
- Minimum of 2 years primary biotechnology cell culture and/or
recovery and purification experience, preferably in
clinical/commercial GMP manufacturing.
- Minimum of 2 years of experience bringing biotechnology
equipment and processes from design through GMP operational
readiness.
- Minimum of 2 years in a supervisory or management role.
- Must have experience with and demonstrated understanding of
Good Manufacturing Practices (GMP) and applicable regulations
(e.g., ICH Q7A, 21 CFR Part 211, etc.).
- Must have experience writing, reviewing and approving GMP
documentation.Compensation Range$129,500 - $155,400AGC Biologics
offers a highly competitive compensation package and a friendly,
collaborative culture that values personal initiative and
professional achievement. AGC Biologics is an equal opportunity
employer. All qualified applicants will receive consideration for
employment without regard to age, ancestry, color, family or
medical care leave, gender identity or expression, genetic
information, marital status, medical condition, national origin,
physical or mental disability, political affiliation, protected
veteran status, race, religion, sexual orientation, or any other
characteristic protected by applicable laws, regulations and
ordinances.LI-LH1
Keywords: AGC Biologics, Boulder , Senior Manager, MSAT - Upstream Lead, Executive , Boulder, Colorado
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