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 Director of Manufacturing Science and Technology (MSAT) 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 & People Management:
- Proactively promote positive Safety Culture and cGMP operating principles.
- 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 need.
- 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 development.
- 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 with impacted groups to develop and execute effective CAPA.
- Accountable for overall budget and financial performance of the MSAT organization.
- 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 maintain 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 competent and provided with the necessary tools and equipment to work safely and without health risks.
PRINCIPAL RESPONSIBILITIES – Technical:
Own, 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) at other sites 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 introduction.
- Partner with Research and Development teams to ensure technology and process solutions are meaningful, compatible and executed successfully.
- 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 permanently resolve issues that arise during production through use of master data, process & product monitoring etc.
- Partner with Process Development to ensure the successful integration of process knowledge into manufacturing operations.
- 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 equipment performance.
- Participate in the corporate development of methods, techniques and evaluation criteria to projects programs and people.
- 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 network peers at other manufacturing sites to share and adopt best practices across the network that drive continuous improvement in all technical aspects of production.
- 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 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 investigations etc.).
- In-depth understanding of GMP requirements as they relate to process operations.
- Demonstrated project management capabilities.
- Deep process, equipment, automation, validation and technical knowledge.
- 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 actionable plans.
- Takes responsibility, drives results, and achieves expected outcomes.
- 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 related industry.
- 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.
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 ordinances.