The Associate Director of Upstream Process Sciences and Manufacturing support is responsible for the leadership and management the of the Manufacturing floor support function which supports internal biologic drug substance manufacturing operations (cell culture) at the MA Bio Ops, Lexington plant. The key support services, deliverable, and capabilities within this function include:
- Daily upstream process monitoring, incident response and containment
- Provide SME support and technical leadership for investigations
- SME support to tech transfer
- Drive upstream process improvement initiatives both for short term and long-term process health
- Lead the implementation and improvement of Standard Work system
- Technical coaching/training for team members
- Act as a liaison between manufacturing and other Center function areas
The AD is responsible for driving the organization towards a culture of safety, innovation, collaboration, best practice, accountability, and efficiency. The primary objective is to ensure manufacturing processes are operated as designed and validated.
The AD partners with Manufacturing, Quality, Supply Chain, Engineering, and Regulatory Affairs to provide support of commercial and clinical drug substance manufactured.
30% of Time: Manage and Develop Staff- Through direct supervision and in terms of project coordination, resource allocation, and methodologies.
- Motivate and support the career development and technical expertise of direct reports and communicate company policies/goals/strategies/business results.
- Communicate company policies/goals/strategies/business results.
- Plan resource allocation and assure productive work from direct reports
- Provide guidance and coaching to team members
- Promote and foster a positive safety culture
- Effectively communicate ideas, project goals, and results to team members.
- Foster teamwork and drive project/process improvement.
- Lead cross-functional projects and teams.
30% of Time: Support Routine MFG process for clinical and commercial products
- Ensure routine MFG support are executed timely and smoothly.
- Monitor upstream production process performance.
- Provide support to floor operations, protocol execution, and training of manufacturing staff.
- Troubleshoot process deviations to understand the possible causes from a scientific perspective
- Develop an effective technical training program to improve the technical capability of MFG and other function groups
30% of Time: Define and execute process improvement initiatives
- Develop technical road map for process improvement initiatives for commercial products to improve yield and process robustness
- Interact with digital and data analytics as well as the single use team for process transformation to digital manufacturing
- Interact with MS lab team to drive for short term and long-term process improvement
10% of Time: Tech transfer Support
- Support clinical program tech transfer and site to site transfer of commercial programs as the receiving and the sending site
Education and Experience Requirements
- BS in Chemical/Biochemical Engineering or Chemistry with 12+ years, MS with 10+ years, or Ph.D. with a minimum of 6 years of process development / manufacturing experience with mammalian cell culture of recombinant proteins.
- Proven record of technical leadership in mammalian cell culture, including ability to influence, motivate, and drive technical rigor.
- Proven record as a strong team leader, coached and developed a collaborative team.
- Expertise in tech transfer
Key Skills, Abilities, and Competencies
- Strong technical leadership and experiences in bio-pharmaceutical processing in the area of cell culture.
- Strong leader in coaching and developing staff
- Must possess knowledge of cGMP and commercial operations.
- Excellent communication skills.
- Organizational effectiveness and employee development
- Customer service oriented