Head of Pharmaceutical Manufacturing (Formulation/small molecule/tablet)

REQUIRED EXPERIENCE: Formulation, capsulation, mixing tablets, small molecule, solid dose. You must have a scientific degree.

Summary/Objective

This individual 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. However, the ideal candidate will have a strong background in pharmaceutical manufacturing (specifically, experience in solid dosage form formulation, for small molecules) and possess leadership skills.

Title: Plant Operations Manager (open to Sr. Mgr., Asso. Dir., or Dir.)/Head of Pharmaceutical Manufacturing

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 Chemistry or Biochemistry preferred at a minimum, but any scientific degree works
• Must have some kind (1+yr) of formulation experience
• Must have solid dosage/tablet/small molecule experience
• Experience in Manufacturing Operations preferred (but not necessary, if you have the scientific background)
• Strong knowledge of cGMP regulations and quality control processes.
• Experience in solid (capsule or tablet) dosage manufacturing required (and preferred if some liquid form dosage manufacturing)
• Must understand drug product cGMP
• Must understand quality systems

Additional Notes

• 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

Biopeptek Pharmaceuticals - Current Openings (workable.com)