Lilly Supervisor - QC Microbiology Lab in Branchburg, New Jersey
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The supervisor of the QC Microbiology Microbial identifications/ materials group leads and manages the day-to-day activities of the group. The group's responsibilities include performing routine microbial identifications (gram stain, Vitek, MicroSeq), media qualifications to support routine microbiological testing in all micro labs, conducting bioburden method suitability studies for new products, overseeing biosafety testing at contract labs and maintaining all documentation and equipment associated with testing.
The supervisor oversees up to 15 direct reports. Serves as a technical expert on the methods performed in the microbial identifications/ materials group and the results obtained. Performs data review. Plans work for the group to respond to changing priorities. Maintains a safe, organized and compliant work area according to company safety standards, cGMP regulations and data integrity requirements. Coordinates and ensures compliance with cGMP and approved laboratory procedures through training of Microbiologists, hands on review of effectiveness, review of documentation and initiation of preventative/corrective actions. Works independently and communicates with his/her staff. Ensures communication of critical information to senior management for key decision-making. Participates in the budget process. Monitors group spending to remain on track with annual budget. Takes initiative to make things better for the company, leads by example and builds collaborative relationships. Builds a strong, responsive team that is reliable and flexible to shifting demands.
Oversees daily laboratory functions
Schedules workload and ensures timely execution.
Identifies discrepancies and conducts laboratory investigations in a timely manner.
Reviews test results for conformance with specifications and effective documents.
On time trending of data for the assigned laboratory group. Evaluates data to detect product or method-related trends. Writes periodic trend summaries.
Compiles and analyzes data, prepares graphs and writes SOPs/reports. Conducts document reviews.
Ensures lab work complies with cGMP and data integrity requirements.
Ensures ongoing compliance with major pharmacopoeia relevant to the lab.
Leads the implementation and sustainment of lean and continuous improvement initiatives.
Personnel Management and Development.
Participates in and supervises the training of QC Microbiology personnel, including mentoring personnel and provides technical expertise.
Provides assistance to coworkers for troubleshooting, laboratory investigations and problem resolution.
Implements process improvements with management.
Plans and organizes analytical projects required to achieve group and corporate objectives. Sets group objectives with management. Participates in internal and external audits. Interacts with auditors, responds to observations and recommends corrective action.
Interviews, hires and supervises QC Microbiology personnel.
Evaluates, coaches and manages personnel performance. Prepares performance reviews, facilitates disciplinary actions, and resolves personnel issues.
B.S. in Microbiology or related sciences is required (M.S. in Microbiology or related sciences is preferred).
Minimum of 2 years supervisory experience in a GMP environment.
Proven competence in area to be supervised with minimum of 4-5 years of related technical experience (microbial identifications/ bioburden method suitability/ biosafety testing).
Excellent working knowledge of cGMP regulations for QC laboratory applications.
Excellent working knowledge of data integrity.
Good working knowledge of compendial requirements.
Good project management and organization skills.
Proactive and timely resolution of issues.
Continuous improvement mindset.
Excellent teamwork and communication skills.
Attentive to detail.
Good computer skills.
Competent with computerized data storage systems (i.e., MoDA, LIMS, TrackWise, etc).
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!