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Supervisor, Manufacturing Jobs

Company

Resilience
Address , Durham, 27713, Nc
Employment type FULL_TIME
Salary $94,000 - $118,750 a year
Expires 2023-07-18
Posted at 11 months ago
Job Description
General Company Description
Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit
www.resilience.com
.
Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)
This role will contribute to the overall success of our novel gene therapy approaches. The Resilience team is seeking a Manufacturing Supervisor with a patient-focused work philosophy to join our facility in North Carolina’s Research Triangle. As a single point of accountability for all aspects of an area’s shift operations, you will have responsibilities for leading the execution of lentiviral vector (LVV) manufacturing, a critical starting material in our gene therapy platform. You will be directly responsible for a team of Manufacturing Associates processing in upstream, downstream and aseptic fill/finish. The ideal candidate will be an ambitious leader with a proven track record of building a safety culture, driving the highest standards of a quality mindset, and ensuring uninterrupted supply for patients. This role requires exemplary skills to organize, manage, and continuously improve the manufacturing operations process.
Job Responsibilities (core responsibilities; include people management if applicable)
  • Establish systems and oversee operations related to GMP vector manufacturing at the site.
  • STRATEGY and COST: Successfully perform technology transfers consistent with Resilience’s overall manufacturing strategy and achieve continuous process improvement.
  • Provide consistent hands-on support to the manufacturing team on the manufacturing floor through mentorship and training, troubleshooting, and development of process improvements
  • QUALITY: Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities; lead investigations as related to the manufacturing process. Author deviations, and CAPAs as required. Partner with Quality to address issues effectively and compliantly.
  • Offer meaningful career development planning, challenging assignments, and ongoing coaching, invest in creating the next generation of leaders at Resilience.
  • SAFETY: In compliance with all state and local requirements, identify potential safety hazards and rapidly implement effective actions; Drive a zero-injury and environmental responsible mindset on the team
  • SUPPLY: Develop daily shift schedules and oversee all aspects of execution to deliver on-time and in-full manufacturing and disposition of batches. Ensure documentation (batch records and SOPs) are accurate and updated as required.
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)
  • Excellent communication skills and ability to influence across multiple functions.
  • Should have excellent organizational skills and be able to multitask in a fast-paced environment with changing priorities.
  • Must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be approximately 10%.
  • Experience with new facility startups and process technology transfers is preferred.
  • Strong understanding of operational discipline, FDA regulations and cGMPs
  • Demonstrated ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
  • BS in a scientific discipline with 5+ years of industry experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, purification (clarification, chromatography, TFF,), aseptic fill/finish
  • Experience with both commercial and clinical manufacturing is preferred.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $94,000.00 - $118,750.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.