Senior Director, Manufacturing Science and Technology (MSAT)

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

One Colorado, one team. At our Boulder and Longmont locations, we cultivate a unified team under the banner of 'One Colorado', fostering collaboration among diverse teams and their respective business units. Together, we leverage a shared services objective between the two sites to enhance care for our clients and their patients.

JOB SUMMARY:

The Senior Director of Manufacturing Science and Technology (MSAT) - Drug Substance Mammalian and Cell and 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 & 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 needs.
• 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 the 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 the 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 the 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 areas of responsibility.  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.
• Effectively work with cross-department functions and clients to ensure on-time and technically appropriate tech transfer.
• 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, establishing 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 the 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 for 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.
• Technical knowledge of cell and gene therapy process technologies and their relationship with manufacturing operations and process validation.
• Lead, coach, and mentor direct and indirect reports.
• 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.

EDUCATION/EXPERIENCE:

• 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 of 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:

$194,000 - $266,750 annually

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 
 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.
 

Salary : $194,000 - $266,750