EmployIndy
  • Immediate Opportunities - Life Sciences
  • Indianapolis, IN, USA
  • Full Time
  • Full package of benefits

Manager Microbiology - Exelead

EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for a Microbiology Manager.

Position Overview:
Responsible for managing and setting the direction of the QC Laboratory operations(Microbiology) in a cGMP environment. Main responsibility is to assure the reliability of all data generated by the Quality Control Laboratories and the safety of all personnel.

Major Position Activities & Responsibilities:
1. Supervision, training and development of reporting QC Microbiology staff
2. Assuring laboratory adheres to business plan.
3. Management of the Environmental Program
4. Trend analysis of critical system data
5. Management of the Microbiology laboratories' Budget
6. Responsible for Environmental, Health, and Safety compliance
7. Communication with manufacturing, facilities, and external department staff on analytical operational issues
8. Serve as senior-level reviewer of facility, equipment and product test data
9. Represent QC laboratory in a technical expert capacity on special studies and validations when required
10. Performs special projects and other duties as assigned.
11. As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.

Scope:
Has the responsibility for 3-6 direct reports plus contract employees. The position will be responsible for the reliability of all generated Microbiological data, assuring laboratory adherence to all applicable regulations, support the business plan, and for maintaining the budget and monitoring capital expenditures.

Background Qualifications:
Minimum of a B.S. degree with a major in Microbiology. (Masters degree preferred)
Minimum of eight years of experience in a pharmaceutical manufacturing environment
Minimum of 5 years as a Microbiological laboratory supervisor in a pharmaceutical manufacturing environment or 4 years of microbiological laboratory experience and a higher degree in Microbiology.
Knowledge of QC systems operations, GMP testing/manufacturing environment expertise, microbiological method validation.
Microbiology and environmental systems operations experience in an aseptic environment is requirement.
Project management skills are essential for successful completion of extraordinary tasks.
Ability to communicate at all levels in a pharmaceutical organization. Good interpersonal skills are a must.
 




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