Aseptic Production Manager - 2nd Shift - Vaccine

Summary of purpose/major responsibilities

Responsible for overseeing personnel and activities associated with their shift and ensuring team adherence to all +QDCI standards.

Context of the job/major challenges

Manages people process within a process/product team to meet goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Plans and initiates the overall production schedules and coordinates personnel activities with other manufacturing staff. Reviews batch records for correctness and completeness. Overall responsibilities include employee selection, training, development, counseling recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets. Chief duty involves providing managerial coverage for employees as required during assigned shift hours.

Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, Management Committee, staff meetings), and work unit teams. When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders. Takes a role in implementing new equipment and procedures. Performs all other duties as required by department management. Deviation management, people development, and Quality Assurance of the Aseptic Processing area are required. Background in Aseptic Processing is favorable.

Dimensions/Scope

Their responsibilities are, but are not limited to:

Safety:

• Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings

• Reports all safety issues, concerns, incidents and near misses to the team leadership

• Actively participates in safety walkthroughs coordinated by the department’s safety team

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues

Quality:

• Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections

• Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies

• Supports SGS meetings and proactively addresses observations

• Conducts real time reviews to assess aseptic performance, GMP data entries, and all metrics are accurately updated

• Understands the function of the quality group and works with them to maintain a positive rapport.

Delivery:

• Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.

• Follows escalation procedures to mitigate any variables negatively impacting eOOE.

• Reviews eOOE metrics throughout shift to ensure proper categorization of downtime.

• Ensure training of personnel is assigned and entered as needed in order to support business needs.

• All other duties as assigned. Adheres to all other company time keeping and attendance policies.

Cost:

• Executes procedure as documented to avoid deviations.

• Ensure training methodologies are implemented to improve operator efficiencies.

• Supports all changeover related functions to achieve eOOE standard.

Involvement:

• Works to become trained in all assigned training modules.

• Trains and orients new team members (at any level) as assigned. 

• Participates and leads team meetings.  Understands respect, professionalism and confidentiality.

• Ensures Training coordinator / Trainers, train and guide personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques, and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

All other duties as assigned.

Requirements:

Education/experience

• Must be very detail-oriented and organized with excellent time-management skills

• Strong analytic and problem-solving abilities, as well as the flexibility to change and adapt as the job grows and develops

• Excellent verbal and written communication, interpersonal and presentation skills, as well as the ability to interact tactfully and effectively with employees at all levels of the organizational structure

• Intermediate proficiency in MS Office Suite

• Working knowledge of SAP preferred

• Lean manufacturing preferred

• BS degree in Life Sciences, Engineering or equivalent with relevant experience in manufacturing and/or filling of biological products or 7+ years relevant experience in manufacturing and/or filling of biological products

Experience Required:

• 3-5 years experience in manufacturing and/or development departments

• Must have previous experience in working with a production department of a pharmaceutical company.

• Experience in FDA Regulated Industry

• Working knowledge of cGMP's

Certifications:

• Covid Vaccination

The standard six core competencies are noted below. 

• Entrepreneurship

• Change and Innovation

• Team Performance

• Effective Communication

• Leadership

• Strategic Thinking

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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#LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.