Supervisor, Manufacturing & Process Execution

Resilience; Port Union (OH); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

Annual bonus program

401(k) with company match

Medical, dental and vision coverage

Paid vacation and holidays

Job summary

Resilience is a biotechnology focused company committed to transforming how medicines are manufactured. We seek a Supervisor to lead the Process Operation (Formulation & Parts Prep) and drive high-quality output in a compliant, efficient manner.

The role emphasizes training, SOP and change control management, and collaboration with OE and PET teams to optimize processes across shifts. Excellent leadership and GMP knowledge are essential.

Qualifications

• Experience in GMP or regulated production environment.
• Previous supervisory experience.
• Knowledge of FDA cGMPs.
• Strong communication and leadership skills.
• Problem-solving abilities.

Responsibilities

• Provides direction to PET personnel for efficient use of equipment and materials to produce quality products.
• Coordinate PET activity, scheduling, and improvement initiatives.
• Promote safe work practices and ensure SHE standards are met daily.
• Train PET personnel on equipment, processes, and SOPs; develop training plans.
• Ensure cGMPs and FDA regulations are followed; respond to audits.
• Administer HR policies, performance management, and employee concerns.
• Maintain documentation practices and production logs per company standards.
• Generate deviation reports and lead investigations and corrective actions.
• Review and approve SOPs and change controls for process improvements.
• Promote continuous improvement and lean initiatives across teams.
• Collaborate with OE and PET engineers to optimize processes.
• Participate in design, installation, and qualification of new equipment and facilities.

Skills

GMP knowledge

Supervisory leadership

FDA cGMPs

Communication skills

Problem-solving

Education

B.S. in Engineering/Pharmacy/Science/Business

Tools

LDMS

Veeva

Microsoft apps

SAP

Job description

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 is 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

Position Summary

The Supervisor is a leader for the Process Operation (Formulation & Parts Prep). In this capacity, the Supervisor manages the Process / Package Operation to produce high-quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with another Supervisor), this must be done while maintaining effective employee relations and compliance with cGMP, other regulatory, and SOX requirements, as well as SHE obligations and Resilience standards.

Job Responsibilities

• Provides direction to PET personnel 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, including 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 SHE standards are met on a daily basis.
• Accountable for training PET personnel on equipment, processes, and Standard Operating Procedures. Partners with the PET Coach to develop training plans and assists in providing resources for training.
• Ensures cGMPs are used and followed during production so that all FDA and international regulations are met. Responds to monthly internal audit observations.
• Promotes a positive work environment by effectively administering Resilience Human Resources policies and procedures, including Performance Management, 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 investigations, and recommends and 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 using team-driven processes, key performance indicators, and recognition and rewarding of high performance.
• Collaborates with OE Engineers and 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 controls.
• Provides career development and performance management for direct reports.
• Co-owns life cycle management of PET/Facilities assets.
• Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behavior.
• Maintains presence across multiple shifts.
• Occasionally performs the role of PET Lead when designated.
• Works effectively in a team environment.
• Able to work in a changing and demanding environment.

Minimum Requirements

• Prior experience in a GMP or regulated production environment
• Previous supervisory experience
• Knowledge of FDA cGMPs
• Strong communication and leadership skills
• Problem-solving skills

Preferred Background

• Bachelor of Science in Engineering, Pharmacy, related Science, or Business
• Experience working in a LEAN manufacturing environment
• Working knowledge of LDMS or Veeva, Microsoft applications, and SAP
• Training or experience in formulation, filling, packaging, validation, technology transfer, or change control
• Knowledge of or previous experience managing technical programs or projects
• Strong mechanical, electrical, troubleshooting, and problem-solving abilities
• Ability to direct and participate in cross-functional teams
• Project management skills

Key Relationships

• Internal: PET and other PETs (including other PET Managers), Technical Manager, OEM Suppliers, Quality Assurance, Filling
• External: Other Supply & Demand Sites

Sponsorship or support for work authorization, including visas, is not available for this position.

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 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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $75,000.00 - $112,500.00 per year. 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.