Sanofi Group Laboratory Manager in Swiftwater, Pennsylvania
**2nd shift position- including weekends as necessary OR part of the shift- some flexibility on start/end time - 2/3pm start with 10:30pm/11:30pm end time
The Quality Control Microbiology group supports viral and bacterial testing for all products on the Swiftwater site. This includes but is not limited to sterility, bioburden, environmental monitoring, PCR, potency, inactivation and kinetics testing.
Position Responsibilities :
Identify opportunities in the areas for continuous improvement, submit plans and follow through to implementation
Support daily laboratory operations, including resolution of test schedule conflicts, review of data, assisting analysts in troubleshooting activities and incident investigations.
Facilitate revision of documents as necessary to ensure regulatory compliance
Serve as a coach and mentor by routinely meeting with staff on both a team and individual basis.
Ensure the level of cross-training is sufficient to meet the business needs. Intervene as needed to respond to scheduling conflicts and changes in business demands.
Provide input into performance reviews outlining accomplishments and development needs. Ensure training requirements are met and maintained (test procedures, protocols, etc.).
Ensure laboratory is in an audit ready state at all times
Represent the department during audits and inspections (With various regulatory agencies including the FDA) as a subject matter expert .
This position will be filled to support an off-shift.
Technical Competencies and soft-skills:
Knowledge of cGMP and regulatory requirements
Excellent communication, interpersonal, organization and team-work skills
Supervisory and scientific writing experience
Requires cGMP training
Excellent analytical, organizational and computer skills
Experience with Quality systems [for example: Phenix, LIMS, eDoc, SAP and/or Procal]
Bachelor Degree in Microbiology/Biological Sciences with 10 years' experience or Master Degree in Microbiology/ Biological Sciences with 7 years' of relevant work experience or extensive industry experience in a cGMP/Quality environment required.
Knowledge of microbiological techniques including sterility, bioburden, microbial identification, culturing of both bacterial and viral isolates or tissue culture preferred. Previous Quality Control experience desired. Exceptional attention to detail and strong writing skills are crucial. Candidate should be familiar with cGMP guidelines must be able to work off shift and in a team environment.
Participation in various and assigned phases of Quality Control testing. Duties may include (but not limited to): Visual Evaluation of vials, syringes, plates, bottles and canisters. Documentation, waste disposal, cleaning of laboratories, and all other activities as assigned. Candidate must pass an eye exam to be eligible for this position.
Sanofi Pasteur SA 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.
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.