Supervisor, Microbiology (2nd shift)

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JOB DESCRIPTION:

The Supervisor coordinates all activities of the Microbiology laboratory including internal/external bioburden and endotoxin testing activities, growth promotion and biological indicators testing. The role oversees the execution of bioburden, and endotoxin method development. The position oversees the scheduling and execution of bioburden and endotoxin testing and other testing as required. The Supervisor is responsible for the management and training of the Microbiology laboratory team. The individual also writes, reviews and approves SOPs, OOSs, and deviations. This position supervises the daily execution of the contamination control program. The Supervisor is responsible for the operation the Environmental Monitoring Group, ensuring utilities and facilities are tested according to cGMP requirements. This position supervises the daily operation to support manufacturing activities and is responsible for the review and approval of routine and lot-specific Environmental Monitoring data.

Working Hours:

2nd Shift (2:00 - 10:30pm)

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• Ensures the lab activities are conducted in compliance with all relevant regulatory and compendial guidances. Ensure that GLP is implemented at all times.

• Acts as subject matter expert for the Microbiology laboratory including bioburden, growth promotion, biological indicators, endotoxin, and water tests.

• Interacts with Project Managers to ensure all test parameters and product specifications are available. Ensures test timelines are defined and met.

• Ensures all Bioburden and Endotoxin method development and qualifications meet compendial requirements.

• Interacts with clients during audits as a subject matter expert for the Microbiology laboratory.

• Oversees and reviews/approves test results. Writes SOPs, OOS and other reports as required.

• Releases batch records.

• Manages direct reports and schedules the tests and functions of the laboratory to meet timelines.

• Ensures training of all direct reports and self is current.

• Represents Environmental Monitoring, Bioburden and Endotoxin, in internal and external meetings.

• Maintains laboratory performance metrics on a monthly basis.

• Acts as subject matter expert for the Environmental Monitoring team.

• Oversees and reviews/approves test results and SOPs.

• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].

• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree in Life Sciences field or equivalent experience required.

• Minimum five (5) years of experience in Microbiology.

• Minimum of 1 year of supervisory experience.

• Ability to supervise and motivate laboratory personnel.

• In-depth knowledge of microbiological methods and techniques.

• Excellent verbal and written communication skills.

• In-depth knowledge of Environmental Monitoring and contamination control.

LEADERSHIP RESPONSIBILITIES:

• Directs and provides expert knowledge in the day-to-day function of the Microbiology department.
• Identifies, recruits, and retains top-notch talent.
• Champions PCI Pharma Services 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, and appropriate email, and regular interpersonal communication.
• Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.

The base salary hiring range for this position is $76,000 - $85,500 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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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.