API Operations Manager

Union Agener•Augusta, GA

About The Position

Operational Leadership 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.
The role requires mobility throughout production areas, including the ability to climb stairs and ladders, perform inspections, and lift up to 40 lbs.

Nice To Haves

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.

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.
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.
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 CapEx projects.
Conduct preliminary budget forecasting, scheduling, and review for API production areas.
Manage expenditures to ensure alignment with approved budgets.