QC Manager Chemistry Lab - NW Indy
- Immediate Opportunities - Life Sciences
- Indianapolis, IN, USA
- Full Time
QC Mgr Chemistry Lab - NW Indy
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 a QC Manager for the Chemistry Lab
Responsible for managing and setting the direction of the QC Laboratory operations (Chemistry) 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:
- Responsible for the supervision, training and development of Chemistry staff
- Support of timely analytical testing required for the Stability Program.
- Trend analysis of critical system data
- Management of the budget for the Chemistry laboratory
- Responsible for Environmental, Health, and Safety compliance
- Communicate with Manufacturing, Facilities, Quality Assurance and other external departments on analytical operational issues
- Serve as analytical QC reviewer of test data packets for product release, stability, validation
protocols, special test requests and special studies.
- Represent QC laboratory in a technical expert capacity on analytical methods when required
- As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes. And, the employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by thecompany or consultant providing such training.
- Performs special projects and other duties as assigned.
This position will have responsibility for one supervisor, one instruments specialist, and several
analysts as direct reports. The position will be responsible for the reliability and validity of all
analytical generated data, assuring laboratory adherence to all validated methods, applicable
regulations, to the business plan, and for maintaining the budget and monitoring capital expenditures.
- B.S. degree with a major in Chemistry. (Masters preferred)
- Eight years or more of experience in a pharmaceutical manufacturing Chemistry Lab
- Five years or more experience in management or supervision.
- Knowledge of QC systems operations, GMP testing/manufacturing environment expertise, analytical method validation for analytical techniques. Microbiology and environmental systems operations experience in an aseptic environment is a plus but not a requirement.
- Project management skills are essential for successful completion of extraordinary tasks.
- Ability to communicate at all levels in a pharmaceutical organization