The Manufacturing Manager reports directly to the Director of Operations and is responsible for management of all production areas including Formulation, Filling and Sanitization.
Essential Functions:This description is intended to be illustrative of the major duties performed by the employee assigned to this position.
- Generates, updates, and maintains documentation associated with manufacturing areas.
- Interacts constructively with employees, managers, and cross-functional peers.
- Deploy strategies in reliability to execute the production plan on time and in full.
- Adhere to and promote all applicable procedures, cGMP standards, company policies and any other safety, quality or regulatory requirements. (For example: OSHA, DEA, FDA, EPA, etc.)
- Utilize Lean Manufacturing/Six Sigma concepts to improve manufacturing process, asset utilization and plant performance.
- Interact cross-functionally to ensure production problems are addressed promptly and with quality considerations.
- Coordinates relevant deviation investigations and implements corrective actions to prevent recurrence.
- Routinely suggests and implements innovative solutions focused on continuous improvement.
- Partner on the arrangement of weekly production schedules.
- Analyzes and makes recommendations regarding capital expenditures and efficiency improvements in manufacturing areas.
- Manage staffing levels and budget spending.
- Other duties as assigned.
Supervisory Responsibilities: - Directly hire and lead a team of technicians, leads, and supervisors.
- Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
- Conduct regular 1:1's to address performance, feedback and relationship building.
- Identify training and development needs within the team and facilitate as able.
Experience and Necessary Skills:- Bachelor's degree in a technical or other relevant field or equivalent experience required.
- 4+ years of managing facilities for a cGMP FDA regulated pharmaceutical manufacturing environment required.
- Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
- Strong Troubleshooting and Root cause analysis
- Able to work in work in a fast-paced environment and adaptable to change.
- Demonstrated written and oral communications skills including strong presentation skills.
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines required
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements:- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
- Ability to maintain a gowning qualification, if applicable.
- Ability to work majorly on-site with remote support needed to provide support across three shifts.
Benefits: - Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- Flexible Spending & Health Savings Accounts (FSA & HSA) available
- Dental & Vision insurance
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
