Manufacturing Manager

KVK Tech is looking for a Manufacturing Manager to join our team in Newtown, PA.

The Manufacturing Manager is responsible for managing the manufacturing of solid dosage forms of tablets and capsules. The Manufacturing Manager ensures that the Standard Operating Procedure’s guidelines and company policies are readily available and met by the Manufacturing Supervisor and operators. Ensure the manufacturing operators are in compliance with the cGMP requirements.

This position’s responsibilities will include, but not be limited to the following:

• Manage and coordinate with Quality Assurance and Quality Control on all Production activities.
• Manufacturing Manager ensures that the Standard Operating Procedure’s guidelines and company policies are readily available and met by the Manufacturing Supervisor and operators.
• Ensure the manufacturing operators are in compliance with the cGMP requirements.
• Maintain required documentation as per cGMP guidelines of the FDA.
• Responsible for all operation employees’ training.
• Coordinating all shift schedules.
• Plan, coordinate, troubleshoot and procure all the tools necessary and support the manufacturing operators in achieving the productivity targets.
• Ensures that the team leaders are adhering to all safety procedures and identifying/communicating the necessary adjustments to address potential safety concerns. The Manager will also ensure the Supervisor/ team leaders are enforcing the proper wearing of PPE (personal protective equipment).
• Identifies employee development needs based upon personal assessment and feedback from Supervisor/ team leaders.
• Supports and develops a comprehensive continuous and structured training program for the site.
• Maintains primary communication of performed goals and requirements as identified by production management.
• Focuses on driving productivity improvements while maintaining high quality standards.
• Initiates/supports revision and approval of Batch Manufacturing Records and SOP’s.
• Supports attainment of Supervisor/team leaders’ goals.
• Works collectively with production, customer service and other necessary areas to ensure timelines are met and results are achieved.
• Writes deviations/investigations and performs root cause analysis to formulate an effective CAPA plan.

Benefits Include:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays

We are looking for applicants with:

Bachelor’s Degree preferred.
10+ years of experience in the pharmaceutical industry.

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.