Biomanufacturing Process & Operations Lead

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

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.