Associate Director, Manufacturing

Job Title - Associate Director, Upstream Manufacturing

Work Location - Cranbury NJ

Job Summary

Reporting to the Head of Manufacturing, the Head of Upstream will play a pivotal role in establishing the Manufacturing Department initially during start-up by supporting operational readiness and providing operations input to ensure the facility design meets end-user requirements and latterly, post-start-up, by leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Upstream Lead will work closely with the management team and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the MFG11 Facility

Responsibilities

• Key member of the Manufacturing leadership team for MFG11. Will play an important role in the strategy and business planning processes, ensuring cross-functional collaboration and leadership execution.
• Support the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans.
• Lead a team of Shift Leads, Specialists, and engineers to execute routine manufacturing activities in the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility.
• Supervise daily Upstream manufacturing activities and ensure production timelines are met.
• Collaborate with the management team and MSAT groups on technical transfer and process validation
• Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
• Provides working knowledge and technical leadership in cell culture operations.
• Schedule and/or deliver training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
• Motivate, retain, develop existing group members and recruit new staff to build a strong Upstream manufacturing team
• Contribute to continual improvement of all manufacturing documentation (SOP MBRs, OJTs) to ensure they are current, accurate, and clear.
• Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
• Assist the Head of Manufacturing in coordinating the work between the Upstream groups and other functional groups to meet the production objectives and timelines.
• Perform all duties by GMP requirements, SOPs, and controlled documents
• Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Lead
• Will act as a role model for the Manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture.
  
  
  
  

Qualifications

• BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology. Masters level qualification would be advantageous.
• More than 10 years in biopharmaceutical manufacturing with extensive experience in Upstream processing.
• Experience in dealing with FDA, and/or EMA and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
• Experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI).
• Ideally, experienced in establishing a Manufacturing department and building a team in a ‘greenfield’ context of similar size and scale
• A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
• A strong background in cellular metabolism, and various mammalian cell lines, and be scientifically minded. Hands-on experience with various size bioreactors (both single-use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired. The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
  
  
  
  

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability