Filling Aseptic Process Manager- Vaccines

Sanofi; Swiftwater (Monroe County); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking global healthcare company as a Filling Aseptic Process Manager, where your expertise will help ensure the highest standards in vaccine production. In this vital role, you'll oversee operations, manage personnel, and drive continuous improvement initiatives. With a focus on safety and quality, you'll collaborate with diverse teams to enhance production efficiency while adhering to strict regulatory standards. This position offers an exciting opportunity for growth and development within a supportive environment committed to innovation and excellence in healthcare solutions.

Benefits

Healthcare benefits

Wellness programs

Parental leave

Opportunities for growth

Comprehensive rewards

Qualifications

• 1+ years in manufacturing or development departments.
• Knowledge of FDA regulations and cGMPs.

Responsibilities

• Manage shift processes to meet production goals.
• Ensure compliance with regulatory authorities and safety procedures.

Skills

Detail-oriented

Problem-solving

Analytical skills

Communication skills

Interpersonal skills

Time-management

Education

BS in Life Sciences

BS in Engineering

Tools

MS Office

SAP

Job description

Job Title: Filling Aseptic Process Manager

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Responsible for overseeing process, personnel, and activities associated with the assigned PCU and shift, ensuring team adherence to all +QDCI standards. Drive continual improvement of line and team performance through leading and supporting projects and initiatives, including investigations into deviations from planned outcomes and associated CAPA to prevent reoccurrence.

This role is for an exempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Context of job/major challenges:

• Manage the process within the shift to meet goals and priorities, ensuring operations are conducted in compliance with regulatory authorities, including cGMPs, CBER, WHO, EP, and others.
• Plan and initiate overall production schedules; coordinate personnel activities with other manufacturing staff.
• Review batch records for correctness and completeness.
• Handle responsibilities such as employee selection, training, development, counseling, cost reductions, profit improvement, quality assurance, incident investigations, and managing departmental budgets.
• Provide managerial coverage for employees during assigned shift hours.
• Coordinate technical process improvements and communicate issues to management and work teams. Collaborate with Maintenance, Metrology, and Validation leaders as needed.
• Implement new equipment and procedures.
• Perform other duties as required, including deviation management, people development, and QA of the Aseptic Processing area. Background in Aseptic Processing is favorable.

Responsibilities include:

Safety:

• Follow all safety procedures; participate in safety meetings and walkthroughs.
• Report safety issues, concerns, incidents, and near misses.
• Contribute ideas for safety improvements and support safety initiatives.

Quality:

• Maintain awareness of regulatory audits; serve as a point of contact for training discussions during inspections.
• Ensure operations comply with cGMPs, CBER, WHO, EP, and other standards.
• Support investigations and CAPA development to address deviations.
• Review GMP data and metrics in real time.

Delivery:

• Analyze data to identify improvement initiatives, working with CI specialists and engineering teams.
• Support production based on volume and business needs; ensure proper staffing and escalation procedures.
• Review downtime metrics and ensure personnel are trained appropriately.

Cost:

• Drive continuous improvement and cost reduction initiatives.
• Ensure adherence to documented procedures and effective training methodologies.

Involvement:

• Complete assigned training modules; train and orient new team members.
• Lead team meetings; promote respect, professionalism, and confidentiality.
• Ensure trainers maintain qualified status.

All other duties as assigned.

About You

Education/Experience:

• Detail-oriented with excellent organization and time-management skills.
• Strong problem-solving and analytical skills; adaptable to change.
• Excellent communication, interpersonal, and presentation skills.
• Proficient in MS Office; working knowledge of SAP preferred.
• Lean manufacturing and mechanical/engineering skills are a plus.

Education:

• BS in Life Sciences, Engineering, or equivalent, with at least 1 year of relevant experience, or 7+ years of relevant manufacturing experience in lieu of degree.

Experience Required:

• Minimum 1 year in manufacturing or development departments.
• Previous experience in a pharmaceutical production environment.
• Knowledge of FDA regulations and cGMPs.

Why Choose Us?

• Bring science to life with a supportive, innovative team.
• Opportunities for growth and career development, locally and internationally.
• Comprehensive rewards and benefits, including healthcare, wellness programs, and parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a diverse workforce. All qualified applicants will receive consideration without regard to protected characteristics.

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Compensation will be based on experience. Benefits details can be found here.