API Operations Manager
Role details
Job location
Tech stack
Job description
-
Lead daily activities across Fermentation, Purification, and Aseptic processes to meet production schedules and ensure schedule adherence.
-
Coordinate production changes and preventative maintenance activities with Operations, Engineering, and Maintenance teams.
-
Ensure all process equipment and controls undergo necessary preventative and process checks in accordance with SOPs and cGMP requirements.
-
Oversee small capital and improvement projects, including contractor activities.
-
Quality & Compliance
-
Submit, investigate, and approve deviation investigations and change controls.
-
Maintain classified environment integrity by ensuring proper equipment, training, and procedures within biological, chemical, and aseptic production areas.
-
Ensure all personnel in API areas are properly trained and qualified through required SOPs/modules.
-
Safety & Environmental Stewardship
-
Ensure all work complies with ES&H guidelines, site safety policies, and regulatory requirements.
-
Promote and maintain high environmental, health, and safety standards throughout manufacturing areas.
-
People Leadership
-
Lead and mentor the manufacturing operations team, fostering collaboration across departments.
-
Coach direct reports and support shifts leads in hiring, performance management, and professional development.
-
Oversee performance reviews, incentive reviews, and development planning for staff and indirect reports.
-
Manage area staffing, overtime, shift alignment, and vacation schedules to meet business needs.
-
Financial & Resource Management
-
Provide input for capital budgeting and CapEx projects.
-
Conduct preliminary budget forecasting, scheduling, and review for API production areas.
-
Manage expenditures to ensure alignment with approved budgets.
Requirements
- B.S. Degree in Engineering/technical field or equivalent experience required.
- Experience developing, implementing, and maintaining environmental and safety programs aligned with strict organizational goals.
- Strong verbal and written communication skills appropriate for multiple organizational levels.
- Excellent planning, organizational, interpersonal, and prioritization skills.
- Demonstrated team-building ability and skill in facilitating action plans.
- Proficiency with computer systems, including Microsoft Office.
- Comfortable working across all levels of a manufacturing environment., * Minimum three years chemical or pharmaceutical experience.
- Minimum two years demonstrated leadership experience in manufacturing, engineering, and/or maintenance management.
- Excellent verbal and written communication skills tailored to the appropriate audience
- Good interpersonal skills, planning, organization and prioritizing are essential.
- Team building skills, along with the ability to facilitate action plans.
- Must have knowledge of computer systems and software applications (SAP), including Microsoft Office applications.
- Ability to work well at all levels within the organization, comfortable in a manufacturing environment
- Ability to communicate influence and coach employees at all levels in the organization.
- Must have experience in accessing, developing, implementing, and maintaining necessary environment programs and initiatives to promote and achieve strict safety/environmental goals, standards, and objectives., * The role requires mobility throughout production areas, including the ability to climb stairs and ladders, perform inspections, and lift up to 40 lbs.
Benefits & conditions
Pulled from the full job description
- 401(k) matching
- Employee assistance program, * Competitive Salary
- Competitive Benefits Package and Employee Assistance Program
- 401(k) Plan + Company Match
- Vacation + End of Year Vacation (Company Sponsored)
- Growth Opportunities to expand your career