We are seeking an Associate Director Microbiology
for our Biologics Testing Solutions site located in Malvern, PA
. You may be required to work a rotating shift schedule that may require weekend hours.
Responsible for technical oversight and operational performance of the company's business as it relates to sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification, and site contamination control. Primary liaison for assigned key client(s) to establish and foster best practice initiatives, provide technical and operational consultation, enhance communication, and facilitate positive client relationships. Will be responsible for providing technical support to both regulatory and client inspections and audits.
The following are responsibilities related to the Associate Director Microbiology
- Provide technical guidance to staff, scientists and clients as needed.
- Responsible for refinement and development of assays as needed to meet current industry standards and the subsequent training of technical personnel in general laboratory skills; reinforce regulatory concepts (CGMP) and specific laboratory techniques. Develop and recommend departmental budget and authorize expenditures.
- Develop and recommend departmental budget and authorize expenditures.
- Provide guidance to Customer Service department in drafting proposals, reviewing proposals and handling customer relations.
- Maintain assays in a state of current industry standard validation, including revalidation when necessary to meet regulatory expectations.
- Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
The following are minimum requirements related to the Associate Director Microbiology
- Education: Bachelor's degree (B.S./B.A.) or equivalent in biology, microbiology or a related discipline.
- Experience: 10 to 12 years' experience in contract laboratory environment operating in a cGMP environment. Prior supervisory/management experience required. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Other: Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries is required.