Snr / Director Manufacturing Science and Technology (MS&T)
Company: AGC Biologics
Posted on: June 19, 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.SummaryThe Director of
Manufacturing Science and Technology (MS&T) - Cell & Gene
Therapy role defines and directs the activities of a team
responsible for process transfer (external and internal) and
process improvement activities. Working closely with our customer
base and all key site departments to enable excellence in
manufacturing by providing tactical and strategic technical support
to the organization & our customers that results in safe, high
quality, and continuously improving production for clinical and
commercial phase projects.PRINCIPAL RESPONSIBILITIES - Leadership &
- Proactively promote positive Safety Culture and a cGMP
- Build and nurture the MSAT team to create a high performing
team that embodies action orientation, timely and effective
communication, a sense of urgency and where your team is inspired
to achieve goals that meet the immediate and longer-term business
- Be an active and visible change agent, promoting a flexible and
open mindset that embraces new opportunities, challenges the status
quo and drives for excellence.
- Establishes strategic goals and objectives that drive MSAT
responsibilities, organizational performance, and team
- As a site leadership team member, the expectation is to drive
collaboration within site and across the network, engage in
cross-functional planning, and demonstrate critical
decision-making. Partner with other site leaders and key personnel
to establish strategic plans and objectives.
- Utilize MSAT team's technical skills and process knowledge to
participate and/or lead investigations through to root cause
determination. Collaborate within the organization to develop and
execute effective CAPA.
- Accountable for overall budget and financial performance of the
- Work closely with our customers to ensure that their projects
are executed successfully through the transfer, implementation,
validation, filing, and licensing of their new products/processes
and maintaining their existing products/processes.
- Implement, enforce and take ownership of all AGC Biologics
Safety, Health & Environmental (SHE) requirements and initiatives
within his/her areas of responsibilities. Ensure all employees are
trained, capable and provided with the necessary tools and
equipment to work safely and without health risks.PRINCIPAL
RESPONSIBILITIES - TechnicalOwn, execute and improve the MSAT
team's deliverables as follows:
- Continuously monitor, analyze, optimize, and ensure validation
of ongoing production and cleaning processes.
- Work closely with the Process Development groups (PD) to ensure
the design and scale up of processes, instruments & equipment from
the laboratory, through pilot scale are executable by manufacturing
operations when moving into full-scale manufacturing.
- Planning, development and implementation of new process
formulas, establish operating equipment specifications and the
improvement of manufacturing techniques and new process equipment
- Partner with Manufacturing to ensure that Manufacturing
operations are set up for success through the provision of high
quality batch records, robust processes and new technology.
Anticipate, respond to and resolve issues that arise during
production through use of master data, process & product
- Partner with Process Development to ensure the successful
integration of process knowledge into manufacturing
- Support the Business Development function by providing
technical expertise for 'process fit' evaluations for the
development of responses to RFPs.
- Exceptional analytical problem solving skills, including the
ability to drive the resolution of complex issues where analysis of
events or data requires an in-depth knowledge of process and
- Regularly interacts with AGC executives and customers.
Interactions frequently involve the use of soft skills such as
negotiation, influencing, conflict resolution and balancing the
interests of the customer with those of AGC.
- Partner with network MSAT teams and peers at other
manufacturing sites to share and adopt best practices across the
network that drive continuous improvement in all technical aspects
- Encourage the use of Lean concepts, while fostering and
advocating a continuous improvement mindset and culture throughout
the organization by encouraging experimentation and
learning.Knowledge, Skills & Abilities
- Technical expertise in multiple biologics platforms &
technologies including Viral Vector and/or Cell Therapy
Manufacturing, along with upstream and downstream process
technologies and their relationship with manufacturing operations
and process validation.
- Detailed understanding of CMC and commercial manufacturing and
the related quality systems (change control, deviations
- In-depth understanding of GMP requirements as they relate to
- Demonstrated project management capabilities.
- Deep process, equipment, automation, validation and technical
- Possesses strong verbal and written communication skills and
the ability to influence at all levels.
- Builds trustful and effective relationships.
- Able to think strategically and translate strategies into
- Takes responsibility, drives results, and achieves expected
- Bachelor's Degree required (science or engineering).
- Graduate or higher-level Degree is preferred.
- 10-15 or more years' work experience in the pharmaceutical or
- 5-10 or more years' people management experience.
- Significant experience in bringing biotechnology equipment and
processes from design through to clinical and GMP operations.
- Extensive experience with start-up and validation of
manufacturing equipment, utility and process systems, including
requirements for documentation and testing.Compensation
Range$162,900 - $218,300AGC 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.
Keywords: AGC Biologics, Longmont , Snr / Director Manufacturing Science and Technology (MS&T), Executive , Longmont, Colorado
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