Supervisor, Manufacturing & Process Execution (Nights)

Resilience; Olde West Chester (OH); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

Annual cash bonus program

401(k) plan with company match

Healthcare package (medical, dental, V

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is seeking a Supervisor for the Process Operation (Formulation & Parts Prep) to lead PET production with a focus on cGMP compliance and continuous improvement. You will manage staff, clinics, audits, and documentation while ensuring quality and regulatory standards.

The role requires prior GMP exposure, supervisory experience, and strong leadership. Redemption of manufacturing processes will occur on a 12-hour night shift, with opportunities to drive efficiency and safety across

Qualifications

• Minimum experience in a GMP/regulatory production environment.
• Previous supervisory experience.
• Strong communication and leadership abilities.

Responsibilities

• Provide direction to PET personnel for efficient use of equipment and materials to produce quality products.
• Coordinate support staff, scheduling, and continuous improvement.
• Promote safe work practices and comply with SHE standards.
• Train PET personnel on equipment, processes, and SOPs.
• Ensure cGMPs and regulatory requirements are followed in production.
• Review deviations, assist investigations, and implement solutions.
• Approve deviation investigations as appropriate.
• Maintain proper documentation practices in manufacturing documents and logs.
• Drive continuous improvement using KPIs and lean principles.
• Collaborate with OE and PET Engineers to optimize process performance.
• Participate in design, installation, and qualification of new equipment and processes.
• Provide career development for direct reports and co-own asset life cycles.

Skills

GMP knowledge

Supervisory experience

FDA cGMPs knowledge

Communication skills

Problem-solving

Education

Bachelor's degree in Engineering, Pharmacy, related Science or Business

Tools

LDMS

Veeva

Microsoft Office

SAP

Job description

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).
• Internal: Technical Manager.
• Internal: OEM Suppliers.
• Internal: Quality Assurance.
• Internal: Filling.
• External: Other Supply & Demand Sites.

Shift

12-hour night-shift, 2-2-3 rotating schedule.

Sponsorship

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

Equal Employment Opportunity

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.

Benefits

• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Benefits package which is thoughtfully designed to support 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.
• 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.

Company Overview

Resilience 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.

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