Manager/Sr. Manager Manufacturing Services
Company: AGC Biologics
Posted on: August 6, 2022
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 and cell and gene
therapies. 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.
The Manager/Sr. Manager of Manufacturing Services is responsible
for overseeing the manufacturing supporting team to enable the
efficiency of LGT Manufacturing teams. Specific responsibilities
include managing the manufacturing compliance and deviation
investigation team, the manufacturing training team, the
manufacturing project portfolio, and manufacturing operational
- Create and drive a vision for manufacturing support and process
excellence in manufacturing at the Longmont site.
- Oversee a team of direct reports whose responsibilities include
manufacturing compliance, manufacturing training, operational
excellence, and the manufacturing project portfolio.
- Owning the process to identify improvement opportunities,
manage the projects, and implement the solutions.
- Ownership of the manufacturing Change Controls with the support
of Manufacturing managers.
- Own and drive manufacturing KPI around CAPA delivery, Change
Control, deviation investigation delivery, training, and project
- Communicate with manufacturing managers to ensure deviation
investigation is closed on time.
- Develop and support the leads and the team members on the
different functions within manufacturing services.
- Support production scheduling and planning.
- Managing and planning resources to effectively and efficiently
support LGT site manufacturing strategy.
- Manage contract cleaning team for GMP and Non-GMP areas.
- Manage consumable gowning supply for GMP process.
- Manager Role: BS / BA degree in life sciences or related field
with 8+ years of industry experience; or Master's degree with 6+
years of industry experience
- Sr. Manager Role: BS / BA degree in life sciences or related
field with 10+ years of industry experience; or Master's degree
with 8+ years of industry experience
- A minimum of 5+ years management experience in clinical or
commercial Manufacturing or Process Development with a preference
toward biopharmaceutical or other regulated industries
- Direct experience communicating with regulatory inspectors
during GMP inspections
- Experience supporting clinical and commercial GMP
- Experience with Biotech processing equipment (examples include
biological safety cabinets, bioreactors, chromatography, TFF, and
- Operational knowledge, clean room operation and cGMP facility
- Equivalent combination of education and experience may
substitute for stated requirements
AGC 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
Keywords: AGC Biologics, Longmont , Manager/Sr. Manager Manufacturing Services, Executive , Longmont, Colorado
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