Manager, Operations - (Turnaround/Changeover)

Biopharma Careers; Elkton (KY); On-site; USD 96,000 - 151,000; Full time

Job summary

Biopharma Careers in Elkton, VA seeks a Turnaround Lead to plan, coordinate, and direct API/Drug Substance turnaround activities. The role focuses on safe, compliant and efficient execution across campaigns and enabling a high-performing cross-disciplinary team.

The candidate will develop a standardized turnaround model, drive continuous improvement, and ensure readiness with stakeholders. Strong leadership, planning, and lean skills are essential for success.

Qualifications

• Bachelor’s degree in engineering, operations, manufacturing, chemical or pharmaceutical engineering, or related technical discipline.
• Minimum of 5 years in regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, shutdown, campaign transitions, or operational readiness activities.
• Strong continuous improvement mindset and lean principles.
• Experience leading teams and coordinating cross-functional stakeholders in a manufacturing environment.
• Demonstrated ability to develop standard work, operating systems, and performance metrics.
• Strong knowledge of safe and compliant execution in regulated operations.
• Proven leadership skills with the ability to coach, develop, and motivate teams.
• Strong planning, prioritization, problem-solving, and decision‑making skills.
• Excellent communication and influencing skills.

Responsibilities

• Lead the planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
• Ensure all turnarounds are executed safely, compliantly, efficiently, and with minimal disruption to manufacturing operations.
• Develop and maintain a standardized, repeatable turnaround model that supports consistent and predictable campaign transitions.
• Lead, coach, and develop a high-performing team of mechanical, electrical, and operations personnel, as well as operators supporting daily facility operations.
• Establish clear expectations, reinforce accountability, and support the growth and capability of team members.
• Partner with the Production Lead and cross-functional stakeholders to ensure readiness, alignment, and effective execution of turnaround activities.
• Ensure turnaround scope, sequencing, staffing, materials, and work plans are defined in advance and fully prepared for execution.
• Drive disciplined handoffs, strong coordination, and right-first-time performance across all phases of turnaround execution.
• Monitor turnaround performance and identify opportunities to improve schedule adherence, quality, safety, and cycle time.
• Apply lean principles and continuous improvement tools to eliminate waste, reduce variability, and improve operational efficiency.
• Support the use of standard work, visual management, and performance metrics to strengthen turnaround execution.
• Track and report key performance indicators related to turnaround duration, rework, downtime, and execution quality.
• Foster a culture of ownership, teamwork, continuous learning, and operational excellence.
• Support day-to-day facility operations while maintaining focus on turnaround readiness and improvement.
• Contribute to the development of the future Small Molecule operating model in Elkton, VA.

Skills

Aseptic Manufacturing

Biopharmaceutical Industry

cGMP Compliance

Data Analysis

Lean Process Improvements

Operational Excellence

Process Engineering

Production Operations

Production Scheduling

Manufacturing Quality Control

Operational Turnarounds

Organizational Turnarounds

Packaging Operations

People Leadership

Performance Improvements

Process Improvements

Education

Bachelor’s degree in a technical discipline

Tools

Lean Manufacturing Tools

Job description

Job Purpose

The Turnaround Lead is responsible for planning, coordinating, and leading highly effective turnaround activities for the Drug Substance/API operations supporting the future Small Molecule facility in Elkton, VA. This role will ensure safe, compliant, predictable, and highly efficient turnaround execution between manufacturing campaigns ensuring that turnaround targets are achieved. The incumbent will lead a cross skilled Turnaround team in addition to operators supporting day-to-day facility operations. A key expectation of the role is to build a high-performing team culture that drives accountability, collaboration, operational discipline, and continuous improvement. In close partnership with the Production Lead and cross-functional stakeholders, this role will establish a repeatable and standardized turnaround model that supports reliable campaign transitions, reduces downtime, and enables long‑term operational excellence.

Primary Responsibilities

• Lead the planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
• Ensure all turnarounds are executed safely, compliantly, efficiently, and with minimal disruption to manufacturing operations.
• Develop and maintain a standardized, repeatable turnaround model that supports consistent and predictable campaign transitions.
• Lead, coach, and develop a high-performing team of mechanical, electrical, and operations personnel, as well as operators supporting daily facility operations.
• Establish clear expectations, reinforce accountability, and support the growth and capability of team members.
• Partner with the Production Lead and cross-functional stakeholders to ensure readiness, alignment, and effective execution of turnaround activities.
• Ensure turnaround scope, sequencing, staffing, materials, and work plans are defined in advance and fully prepared for execution.
• Drive disciplined handoffs, strong coordination, and right-first-time performance across all phases of turnaround execution.
• Monitor turnaround performance and identify opportunities to improve schedule adherence, quality, safety, and cycle time.
• Apply lean principles and continuous improvement tools to eliminate waste, reduce variability, and improve operational efficiency.
• Support the use of standard work, visual management, and performance metrics to strengthen turnaround execution.
• Track and report key performance indicators related to turnaround duration, rework, downtime, and execution quality.
• Foster a culture of ownership, teamwork, continuous learning, and operational excellence.
• Support day-to-day facility operations while maintaining focus on turnaround readiness and improvement.
• Contribute to the development of the future Small Molecule operating model in Elkton, VA.

Minimum Required Education, Experience

• Bachelor’s degree. Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline. Engineering degree not required.
• Minimum of 5 years of experience in pharmaceutical, biotechnology, chemical, or other regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, shutdown, campaign transition, or operational readiness activities.
• Strong continuous improvement mindset and practical understanding of lean principles.
• Experience leading teams and coordinating cross-functional stakeholders in a manufacturing environment.
• Demonstrated ability to develop standard work, operating systems, and performance metrics.
• Strong knowledge of safe and compliant execution in regulated operations.
• Proven leadership skills with the ability to coach, develop, and motivate teams.
• Strong planning, prioritization, problem-solving, and decision‑making skills.
• Excellent communication and influencing skills.
• Ability to work effectively across Operations, Engineering, Quality, Maintenance, Planning, and EHS.
• Data‑driven mindset with the ability to monitor performance and drive improvement.
• High attention to detail and commitment to operational discipline.

Required Skills

• Adaptability
• Adaptability
• Aseptic Manufacturing
• Biopharmaceutical Industry
• cGMP Compliance
• Data Analysis
• Employee Performance Standards
• Interpersonal Relationships
• Inventory Management
• Key Performance Indicators (KPI)
• Lean Process Improvements
• Manufacturing
• Manufacturing Quality Control
• Operational Efficiency
• Operational Excellence
• Operational Turnarounds
• Organizational Turnarounds
• Packaging Operations
• People Leadership
• Performance Improvements
• Process Engineering
• Process Improvements
• Production Operations
• Production Scheduling
• Productivity Improvements {+ 1 more}

US and Puerto Rico Residents Only

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $96,200.00 - $151,400.00

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

• medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: Domestic/International

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): NA

Job Posting End Date: 10/1/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R408380