Production Manager

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Position: Production Manager

Department: Operations

Reports To: Operations Manager

FLSA Status: Exempt
Location: On-Site - Charlottesville, VA

Afton Scientific is seeking an experienced and highly motivated Manager, Pharmaceutical Production to provide leadership and oversight for our pharmaceutical manufacturing operations. This position is responsible for leading production activities, developing employees and frontline leaders, coordinating manufacturing schedules, and ensuring operations are performed safely, efficiently, and in accordance with applicable quality and regulatory requirements.

This is an excellent opportunity for an experienced pharmaceutical manufacturing professional who is ready to take on greater leadership responsibility and play a key role in the continued development of Afton's production organization.

Compensation

$90,000 - $130,000 per year

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

Primary Responsibilities

• Provide overall leadership and management of pharmaceutical manufacturing operations.
• Provide direct supervision and guidance to production leadership, including the Supervisor, Pharmaceutical Production and Senior Specialist, Pharmaceutical Production.
• Coordinate production schedules with Sales and Operations to ensure manufacturing activities are completed according to established timelines and customer requirements.
• Oversee day-to-day production activities while remaining capable of providing hands-on manufacturing support when necessary.
• Perform or support production activities, including preparation, equipment setup, aseptic processing, and facility cleaning, as needed.
• Ensure production personnel are properly trained and qualified to perform assigned responsibilities.
• Partner with production leadership to conduct group training sessions and address training needs.
• Mentor and develop Pharmaceutical Operators for increased responsibility and future leadership opportunities.
• Conduct performance reviews and provide ongoing coaching and feedback to production employees.
• Review and approve operator work schedules, as applicable.
• Partner with Quality Assurance to ensure production-floor documentation is completed accurately and on time.
• Coordinate equipment maintenance and validation activities with Facilities and Engineering.
• Write, review, and edit controlled documentation, including SOPs, batch records, reports, specifications, and policies.
• Review and approve quality documentation, including Operational Deviation Reports, Non-Conforming Material Reports, Change Controls, and Problem Analysis and Corrective Action Reports, as applicable.
• Participate in internal audits and support inspection-readiness activities.
• Develop and maintain productive working relationships across Operations, Quality, Engineering, Facilities, and other departments.

Minimum Qualifications

• Bachelor's degree desired; Engineering or another technical degree preferred.
• Demonstrated experience in pharmaceutical manufacturing or a related regulated manufacturing environment.
• At least three years of experience leading and developing supervisors.
• Strong understanding of cGMP requirements and pharmaceutical production practices.
• Knowledge of aseptic processing, cleanroom operations, and sterile manufacturing practices.
• Demonstrated ability to lead, coach, and develop employees.
• Strong organizational, communication, and problem-solving skills.
• Basic proficiency with Microsoft Word and Excel, with the ability to learn additional database applications.
• Ability to work effectively across departments and manage multiple operational priorities.
• Regular on-site attendance is required.

Preferred Knowledge and Experience

• Previous leadership experience within pharmaceutical production or sterile manufacturing.
• Experience supervising production employees and frontline leaders.
• Experience with aseptic processing and cleanroom manufacturing operations.
• Experience reviewing or managing deviations, non-conforming materials, change controls, and corrective actions.
• Experience authoring or reviewing SOPs, batch records, reports, specifications, and other controlled documentation.
• Experience supporting internal, customer, or regulatory audits.
• Experience coordinating equipment maintenance and validation activities.
• Demonstrated success developing employees and preparing individuals for increased responsibility or leadership positions.

Leadership Competencies

• Leadership & Accountability
• Coaching & Employee Development
• Communication & Collaboration
• Planning & Prioritization
• Operational Excellence
• Quality & Regulatory Compliance
• Problem Solving & Decision Making
• Continuous Improvement
• Talent Development
• Cross-Functional Leadership

Physical & Work Requirements

• Ability to work within cleanroom and pharmaceutical manufacturing environments for extended periods.
• Ability to become qualified in proper aseptic gowning.
• Ability to stand for extended periods, bend and reach to access equipment, and lift up to 50 pounds.
• Ability to work in close proximity to other employees within cleanroom environments.
• Near vision correctable to 20/20, including through corrective eyewear when necessary.
• This is an on-site position; remote work is not available.

What You'll Gain

• The opportunity to lead and influence Afton's pharmaceutical manufacturing operations.
• Significant responsibility for developing production employees and future frontline leaders.
• Increased exposure to production planning, quality systems, validation, engineering, and cross-functional business operations.
• Opportunities to influence operational effectiveness, training, compliance, and continuous improvement.
• Continued leadership development and career growth within Afton Scientific.