Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Summary of Objective:
Responsible for the management of staff and operations within the QC Microbiology group. This includes, but is not limited to environmental monitoring of classified spaces and clean utilities and associated excursion investigations, microbiological testing of Raw Materials, Intermediates and Finished Products, training of staff on aseptic techniques, interacting with regulatory inspectors and clients with regards to microbiological topics and further development of PCI’s microbial and environmental control procedures and policies. Relies on previous experience, analytical skill, and knowledge to make judgements to accomplish goals.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
• Responsible for leadership and oversight of QC Microbiology operations at all NH sites.
• Lead and maintain QC microbiology core programs such as EM, Utility Monitoring, Product Testing.
• Support recruitment, development and retention of QC Microbiology staff.
• Mentor and develop staff to meet technical and business needs.
• Provide support to Investigations team in relation to QC deviations, investigations and quarterly trend reports.
• Work with and provide input to Operations and Facilities groups to maintain the sterility or aseptic nature of processes.
• Represent QC Microbiology in internal audits, external client audits and global regulatory audits.
• Maintain positive relationship and network effectively across sites, organizations and clients.
• Ensure cGMP compliance of all activities performed.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
• Must be able to work at all LSNE sites inclusive of remote locations
• Ability to gown and work in an ISO environment
• Able to lift to 20 lbs.
• May occasionally support off shift activities.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Self-motivated and ability to work with minimal supervision
• Ability to meet aggressive deadlines while multi-tasking; excellent organizational and interpersonal skills
• Works closely with quality assurance, operations, and facilities staff
• <10%. Travel generally consists of routine daily movement between buildings
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Level will take into account years of experience
• 5-8+ years of relevant working experience in QC Microbiology, previous experience in aseptic manufacturing highly preferred
• 3-8 years of management/leadership responsibilities
• Previous experience in aseptic manufacturing highly preferred
• BS in, Microbiology, Biology or related life sciences field. Advanced level degree preferred
• Excellent communication skills, both written and verbal.
• Effective time management, multitasking and organizational skills with the capability to manage multiple priorities at once.
• Strong attention to detail and cross functional team experience.
• Proven strong leadership skills with ability to motivate, inspire and build a high performing team.
• In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
