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Manager, Manufacturing-Packaging (Night)

National Resilience

National Resilience

west chester, oh, usa
Posted on Saturday, October 28, 2023

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Brief Job Description

The Manager, Packaging is a leader for the Process Operation (Packaging). In this capacity, the Manager manages the Process / Packaging Operation to produce high quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with other Supervisors/Managers), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as HSE obligations and Resilience standards.

Job Responsibilities

• Provides direction to PET staff in the efficient use of equipment and
materials to produce quality products in accordance with the PET Plan or
Rhythm Wheel
• Responsible for all PET activity to include coordination of support staff,
scheduling and improvement.
• Promotes the use of safe work practices during all aspects of production and
ensures all external and Resilience HSE standards are met on a daily basis.
• Accountable for training of PET personnel on equipment, processes and
Standard Operating Procedures. Partners with Process Lead and Training Coordinator to develop training.
plans and assist in providing resources for training.
• Ensures that cGMP’s are used and followed during production of products so
that all FDA and international regulations are met. Responds to monthly internal audit observations.
• Promotes a positive work environment by effectively administering people policies and procedures including Performance Management and by communicating information to employees and responding to their concerns.
• Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
• Generates reports for deviations, assists in the investigations, and
recommends/implements solutions to resolve deviations. Approves deviation
investigations as appropriate. Responds to product defect notifications.
• Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
• Promotes and encourages continuous improvement in efficiency, quality,
production, and safety through the use of team driven processes and key
performance indicators and recognition and rewarding high performance.
• Collaborates with OE Engineers & PET Engineers to optimize process
performance.
• Participates in the design, selection, installation and qualification of new
equipment, facilities, and processes.
• Reviews, approves, and implements change control.
• Provides career development and performance management for direct reports.
• Co-owns life cycle management of PET/facility assets
• Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
• Maintains presence across multiple operating shifts.
Occasionally performs rolls for PET Lead when designated.

Minimum Requirements:

  • Prior experience in GMP or regulated production environment
  • Previous supervisory experience.
  • Knowledge of FDA cGMP’s.
  • Strong communication and leadership skills.
  • Problem solving skills.
  • Knowledge or previous experience in managing technical programs/projects
  • Strong mechanical, electrical, troubleshooting and problem-solving abilities.
  • Ability to direct and participate in cross-functional teams.

Preferred Requirements:

  • Bachelor of Science in Engineering, Pharmacy, related Science or business.
  • Experience working in a LEAN manufacturing environment
  • Working knowledge of LDMS, Microsoft applications, SAP, Trackwise, Veeva
  • Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
  • Project management skills.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

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 $100,000.00 - $141,250.00. 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.