Director, Microbiology GMP Operations AR&D

Our Company's microbiology team is seeking a Director for the Rahway NJ, Good Manufacturing Practice (GMP) microbiology operations. The primary objective of the position is to oversee GMP environmental monitoring and microbiological release of pipeline products.The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include executing analytical methods to release clinical drug substance and drug product and support both non-sterile and sterile manufacturing. This role contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable, which involves the development of robust chemical and biochemical processes, market formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality, Pharmaceutical Operations, the other Research & Development Division Microbiology labs in the network and partners in commercialization and manufacturing in aspects of quality control, compliance, and strategic partnering.* Pharmaceutical Microbiologist (Direct GMP Operations Experience).* Strong people management skills.* Extensive experience with sterile operation and sterile testing laboratoriums.* Demonstrated ability in leading teams and talent development.* Project management skills.* Ability to work in a team environment with cross-functional interactions.* Excellent scientific communication, interpersonal, and collaborative skills.* Strength in delivering results on firm deadlines.* Experience representing the laboratory for internal and external audits.* Leads microbiological investigations* Review and approval of data and reports.* SOP development.* Quality System experience.* Thorough working knowledge of GMPs, ICH, Pharmacopoeia, and relevant FDA guidelines.* Desire and ability to learn new concepts outside of core expertise and training* Education Minimum Requirements:* BS or MS in Microbiology/Molecular Biology or related science with at least 10 years of industrial experience leading a QC lab and working together with operations.* Ph.D. in Microbiology/Molecular Biology or related science with 5 years of industrial experience leading a QC lab and working together with operations.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr