API Operations Manager

Responsibilities

• 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.
• 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.
• Provide input for capital budgeting and Cap Ex projects.
• Conduct preliminary budget forecasting, scheduling, and review for API production areas.
• Manage expenditures to ensure alignment with approved budgets.

• 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.

• 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