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About the Role
This position is responsible for managing and leading the day-to-day manufacturing processes associated with commercial aseptic manufacturing of safe, effective, and sterile pharmaceuticals. The scope includes overseeing departments such as Compounding, Equipment/Component Preparation, Sterile Filling, Inspection, and Packaging.
Responsibilities
- Direct shop floor supervision, batch record execution, SOP training, manufacturing investigation reports, and employee payroll.
- Participate in process improvement activities.
- Supervise daily manufacturing operations across departments and make staffing decisions.
- Schedule and direct production personnel to operate the production lines as per the schedule.
- Achieve production performance objectives by delivering quality products in a timely and cost-efficient manner.
- Prioritize and allocate resources to meet annual operating plan and budgetary commitments.
- Hire, train, and evaluate employees' job performance, working with subordinates to further their skills and development.
- Ensure accuracy and timeliness of all batch paperwork according to Good Documentation Practices.
- Oversee cleaning of production areas as per procedures and schedules.
- Monitor safety and take corrective actions to eliminate hazardous situations.
- Address and coordinate problems with relevant departments and bring quality issues to management attention.
- Conduct investigations of process deviations and compile technical documentation.
- Develop technical documents, including Standard Operating Procedures (SOPs), Product/Process Specification Documents (PPSs), Manufacturing batch records (MBRs), and production training records.
- Support employee feedback and developmental processes.
- Emphasize safety and quality commitments within the department.
- Investigate and resolve disciplinary issues, up to and including suspensions and terminations.
- Perform any other tasks/duties as assigned by management.
Requirements
- Minimum 3 years of previous supervisory experience in a GMP regulated industry or 1 to 3 years of leadership experience.
- Must be able to read documents in Standard English, such as Standard Operating Procedures, maintenance schedules, and operating manuals.
Skills
- Strong oral and written communication skills.
- Strong time management, organizational, and project management skills.
- Knowledge of MS Applications (Word/Excel/Outlook/Power Point).
- Chemical handling.
- Mathematical aptitude.
- Ability to troubleshoot and perform minor repairs on manufacturing equipment.
Location
- Onsite
Work Type
- Full-time
Experience Level
- 3 years supervisory experience in GMP regulated industry
- 1-3 years leadership experience
Education Level
- Associate degree
- B.A. or B.S degree preferred
Salary/Compensations
- $91,000 - $100,000
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
About the Company
- American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees.
- American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users.
Equal Opportunity
- We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
- Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf