Supervisor, Manufacturing

Company: Resilience
Location: Durham
Posted on: May 16, 2022

Job Description:

Supervisor, ManufacturingResilience seeks a patient-focused leader as a Supervisor, Manufacturing for RTP Durham facility in North Carolina's Research Triangle Park. As a single point of accountability for the Manufacturing Specialist team, you will provide leadership of the team and support the prioritization and technical expertise needed to support manufacturing operations and systems to supply critical starting material in our gene therapy platform. This role will focus on both technology transfer and routine clinical and commercial manufacturing. This role will work cross functionally to lead the Manufacturing Specialist team with the following departments: Supply Chain, Quality Assurance, Quality Control, Facilities, Manufacturing, Manufacturing Sciences & Technology, Process Development, and Human Resources. We seek candidates with proven ability to develop talent, successfully lead organizations, and drive cross-functional teamwork. Specifically, we are looking for a leader with a track record of building a safety culture, driving the highest standards of a quality mindset, and ensuring uninterrupted supply for patients. As the facility transitions from start-up to routine manufacturing, the role will be a key leader in implementing a cross-functional management system, focusing on identifying KPIs, tracking their performance daily, and rapidly taking action based upon that performance.About the Role:

• Through meaningful career development planning, challenging assignments, and ongoing coaching of the Manufacturing Specialists, invest in creating the next generation of leaders at Resilience.
• In compliance with all state and local requirements, create a culture where potential safety hazards are identified/shared and effective actions are rapidly implemented. Drive a zero-injury mindset on the team.
• Leads and coaches others to manage deviation investigations to adequately identify root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence and drive deviation reduction. Employs standardized root cause analysis, investigational tool and methodologies. Leads and coaches others to author and implement changes controls for the manufacturing area. Ensures that all quality systems records are completed on or before their due dates.
• Provides leadership for technical support for manufacturing. Troubleshoots equipment related issues as a first level response and develops sound engineering solutions to address identified problems, partnering with Engineering, Facilities & IT as appropriate.
• Establish systems and quality mindset to support GMP vector manufacturing at the site. The scope of manufacturing includes cell expansion, upstream, downstream and fill finish operations.
• Writes/revises standard operating procedures (SOPs), training documents (OJTs) and batch records (BPRs) as needed and coaches others to do the same.
• Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness and coaches others to do the same.
• Participate and provide leadership in tech transfer of new products into the facility and coaches others to do the same.
• Provides training and technical development for the manufacturing team and coaches others to do the same.
• Responsible for coordinating activities to support manufacturing (i.e. raw materials and BPR issuance) as needed and coaches others to do the same.
• Develops and maintains departmental metrics and key performance indicators (KPIs) and coaches others to do the same.
• Work closely with Manufacturing and Quality to continually improve all aspects of operations, including proactive initiatives, risk assessments and white papers. Coaches others to do the same.Qualifications:
  • Bachelor's Degree in a scientific discipline with 6+ years of industry experience
  • Must be skilled at and committed to the development of other team members
  • Leadership experience in biologics manufacturing is a must, and experience with viral processing is a preferred
  • 3-5 years in a lead or supervisory or manager role
  • Strong understanding of operational discipline and cGMPs
  • Experience with new facility start-ups and process technology transfers is preferred
  • Experience with both clinical and or commercial manufacturing preferred
  • Excellent organizational skills and ability to multitask in a fast-paced environment with changing priorities
  • Excellent interpersonal, verbal and written communication skills and the ability to collaboratively influence at all levels of the organization
  • Driven and self-motivated to lead and operate in a fast-paced, dynamic, and rapidly growing company environment with minimal direction
  • Must be willing to have a flexible schedule to support 24 x 7 manufacturing activities. Travel is expected to be approximately 10%.

Keywords: Resilience, Durham , Supervisor, Manufacturing, Other , Durham, North Carolina