Supervisor, Microbiology

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Details:
We are currently seeking a Supervisor, Microbiology who supports and assist in leading activities of the Quality Control (QC) Microbiology department. The position oversees, supports, and participates in the execution of process specific and routine environmental monitoring of the manufacturing cleanrooms and associated systems (water and compressed gases). This position will comply under GMP standards while driving quality excellence and maintaining Aji Bio-Pharma cultural values of Customer Focus, Innovation, Accountability, Communication, Compliance, and Teamwork.  

Responsibilities:

• Manages direct reports and schedules environmental monitoring, testing, and lab functions to meet crucial timelines.
• Ensures the lab activities are conducted in compliance with all relevant regulatory and compendial guidances.
• Demonstrates extensive knowledge in environmental monitoring, bioburden, endotoxin, total organic carbon, conductivity and other microbiological tests to support in-process, raw materials, and routine test samples.
• Interacts with Manufacturing and other departments to ensure support of processes and product testing.
• Interacts with clients during audits as a subject matter expert for QC Microbiology.
• Oversees, reviews, and approves test results in a timely manner.
• Authors SOPs, OOS, deviations, trend reports, excursion reports and other quality system reports, as required.
• Oversees CoA generation of batch records.
• Supports batch record review.
• Ensures training of all direct and indirect reports of microbiological test assays and environmental monitoring.
• Regular and reliable attendance on a full-time basis for self and team [or in accordance with posted schedule].

Requirements:

• Bachelor’s Degree in Life Sciences field or equivalent experience required.
• Minimum five (5) years of experience in Microbiology.
• Minimum of 1 year of leadership experience.
• Ability to supervise and motivate personnel.
• In-depth knowledge of microbiological methods and environmental monitoring.
• Excellent organization, verbal and written communication skills.

Leadership Requirements:

• Directs and provides expert knowledge in the day-to-day function of the QC Microbiology department.
• Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
• Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
• Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.

The base hourly range for this position is $76,000 – $85,500 USD plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.