Plant Operations Manager (open to Sr. Mgr., Asso. Dir., or Dir.)
Biopeptek Pharmaceuticals Malvern Full-time
Summary/Objective
The Plant Operations Manager is responsible for setting up the operations of our new manufacturing plant – from working with contractors to determine the appropriate layout of the manufacturing facility all the way through to working with HR to hire personnel, and working with the rest of the team to set up operations for this plant.Experience with starting up a plant from scratch all the way to the plant operating would be great. The ideal candidate will have a strong background in pharmaceutical manufacturing (specifically, experience in solid dosage form formulation) and possess leadership skills.
Title: Plant Operations Manager (open to Sr. Mgr., Asso. Dir., or Dir.)Department: Logistics
Report to (title): CEO
Location: Royersford, PA likely, but alternatively, somewhere within a 30 min radius of Malvern, PA
Supervisory Responsibility: Yes (later, likely)
FLSA Status: Exempt
Position Type: Full-Time
Travel Required: No
Expected Hours of Work: (include any mandatory meeting times with time zone) M-F in office (~9-5)
Description
Essential Duties and Responsibilities- Oversee all plant operations, including production, maintenance, and quality assurance
- Develop and implement strategies to optimize production efficiency and safety standards
- Ensure compliance with cGMP and other regulatory standards.
- Manage and mentor a team of supervisors and operators to achieve production goals.
- Monitor production metrics and adjust plans as necessary to meet targets.
- Collaborate with R&D and Quality Assurance departments to ensure product integrity.
- Maintain accurate records and reports on production activities and inventory.
- Coordinate with supply chain and procurement to align resource availability with production needs.
- Drive continuous improvement initiatives across plant operations.
- Managing production schedules
- Comply with safety and quality regulations
- Lead a team of manufacturing personnel
Requirements
Education, License, Certification, or Preferred Qualifications- Bachelor's degree in Engineering, Manufacturing, or a related field; advanced degree preferred.
- 5+ years of experience in manufacturing operations, preferably in the pharmaceutical industry.
- Strong knowledge of cGMP regulations and quality control processes.
- Experience in solid (capsule or tablet) dosage manufacturing and liquid form dosage manufacturing,
- Must understand drug product cGMP
- Must understand quality systems
- Proven leadership and team management skills with experience in process improvement.
- Excellent problem-solving abilities and analytical skills.
- Ability to communicate effectively with cross-functional teams and external partners.
- Familiarity with manufacturing software and inventory management systems is a plus.
Benefits
-Employer-paid HMO Medical (in Greater Philly area) + Basic Life/AD&D + ST Disability- You pay a portion of Dental PPO, Vision, Medical PPO
- FSA
- 4% match 401k
PTO: 15 days total (vacation/personal days) + 5 sick days + holidays
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