JOB SCOPE
Triumvira is a multi-national, clinical stage biotechnology company with headquarters in Austin, TX and laboratory facility in Hamilton, Ontario. We are a fast-paced, innovative, forward-thinking, and highly collaborative culture of scientists, technologists, R&D and other professionals that focus on therapies for small tumors including breast, gastric, ovarian, pancreatic, gall bladder and lung cancer. Triumvira has developed a proprietary T-cell Antigen Coupler (TAC) therapies that uniquely help T-cells recognize and eliminate tumor cells. We are currently in Phase I/II clinical trials and are excited to advance our pipeline so that we can improve patient lives.
The Associate Director of Manufacturing is responsible for leading the manufacturing team in the execution of cell therapy production, ensuring adherence to cGMP and other regulatory requirements, and driving continuous improvement initiatives to optimize manufacturing processes. This role requires extensive experience in cell therapy manufacturing, as well as expertise in quality systems and strategic planning.
The Associate Director of Manufacturing will be responsible for developing and implementing strategic plans for the manufacturing of cell therapies, including resource planning, budgeting, and establishing performance metrics to ensure production goals are met. This role also involves collaborating with cross-functional teams, including MSAT, quality assurance, quality control, and regulatory affairs, to support product development and commercialization efforts.
To succeed in this role, the Associate Director of Manufacturing must have strong leadership, communication, and collaboration skills, and be able to work effectively with cross-functional teams and external partners. They must also have strong problem-solving and analytical skills, with a focus on strategic planning and execution, and a commitment to continuous improvement.
Overall, the Associate Director of Manufacturing plays a critical role in ensuring the successful commercialization of cell-based therapies, overseeing the execution of manufacturing processes and ensuring compliance with all relevant regulations.
This role requires a deep understanding of cGMP and other regulatory requirements for cell therapy manufacturing, as well as strong leadership and collaboration skills to drive continuous improvement initiatives and optimize manufacturing processes.
JOB DUTIES
1. Develop and implement strategic plans for the manufacturing of cell therapies, including resource planning, budgeting, and establishing performance metrics to ensure production goals are met.
2. Lead the manufacturing team in executing the production of cell therapies, including upstream and downstream processing, quality control, and logistics.
3. Responsible for production related operations and assures adherence to the applicable regulations and standards (GMP, GTP, AABB, Quality Systems, OSHA)
4. Facilitate implementation of appropriate quality systems and continuous improvement initiatives 4.1. Continually monitor results for shifts and trends in all processes as well as facility functions
5. Collaborate with cross-functional teams, including MSAT, quality assurance, and regulatory affairs, to support product development and commercialization effort.
6. Develop and maintain strong relationships with suppliers, contract manufacturing organizations, and other external partners to ensure reliable and cost-effective supply of materials and services.
7. Responsible for troubleshooting problems, evaluating root cause, working closely with Quality Systems to monitor performance and quality indicators; and develop, and implement any necessary corrective actions (CAPA) when appropriate.
8. Ensure compliance with all relevant environmental, health, and safety regulations, and promote a culture of environmental sustainability.
9. Develop and implement training programs to ensure that staff are properly trained and have the necessary skills to execute manufacturing processes effectively.
10. Manage and mentor a team of manufacturing professionals to ensure they are motivated, engaged, and empowered to achieve their goals.
11. Management of applicable study reports along with active participation in IND submission.
COMPETENCIES
1. Expertise in cGMP and other regulatory requirements for the manufacture of cell-based therapies, as well as experience with quality systems and continuous improvement initiatives.
2. Strong leadership, communication, and collaboration skills, with a proven ability to work effectively with cross-functional teams and external partners.
3. Strong problem-solving and analytical skills, with a focus on strategic planning and execution, and a commitment to continuous improvement.
4. Capable of working in a fast-paced and often rapidly changing environment
5. CMC Experience
6. Good technical and teaching skills, able to make sound judgment, good problem-solving skills.
7. Capable of working in a fast-paced and often rapidly changing environment
EDUCATION
Bachelors or Masters degree in bioengineering, chemical engineering, biology, or a related field with 7 years of experience in cell therapy manufacturing, with experience in leading teams and overseeing complex manufacturing operations.
WORK-RELATED SKILLS & EXPERIENCE
• Judgment — exhibits sound judgment and makes timely decisions, escalates issues and ideas as appropriate.
• Planning/organizing — prioritizes and plans work activities, uses time efficiently and develops realistic action plans, adapts quickly to changes in the work environment or priorities, effectively accommodates critical time constraints and competing priorities into the work schedule.
• Problem solving — identifies and resolves issues in a timely manner, gathers and evaluates information competently.
• Oral communication — speaks clearly and persuasively in positive or negative circumstances, demonstrates good presentation (training) skills and leads meetings, communicates effectively with personnel at all levels of the organization, communicates effectively (oral and written) with third parties such as vendor representatives and FDA inspectors.
• Teamwork — is capable of working in a fast-paced environment while interacting effectively in a diverse group.
Candidates must be authorized to work in the US without sponsorship, as Triumvira does not provide support. Triumvira is offering relocation assistance to qualified candidates within the Pacific Northwest region.
NOTICE TO AGENCIES: We do not accept unsolicited resumes or biographies from agencies. Triumvira is not open to Recruiting/Staffing agency support at this time. Our in-house recruiting team manages all employment opportunities. Please do not contact Triumvira employees directly. If you would like to be considered in future years as a vendor partner, submit your company overview to Human Resources.