Lead Pharmaceutical Microbiologist

Lead Pharmaceutical Microbiologist

SL Pharma Labs Inc., a well-established contract Pharmaceutical Development & Clinical Manufacture company located near Wilmington, DE, with easy access to I-95, has an immediate opening for a Lead Pharmaceutical Microbiologist with Aseptic Processing experience. We offer a fast paced, challenging and fulfilling work environment offering a great potential for career advancement.

The Lead Pharmaceutical Microbiologist is responsible for the planning, implementation and successful completion of assigned projects in a timely fashion ensuring consistent high quality and using innovative/novel approaches.  Aseptic processing projects may include preparation of protocols and batch records, and hands-on preparation and evaluation of lab scale and clinical batches.  This person is expected to stay abreast of current parenteral technology and regulatory requirements relating to manufacturing of sterile clinical materials. Other key responsibilities include: development / validation / testing of sterilization cycles, sterility testing, microbial limit testing, endotoxin testing, preservative effectiveness testing, microbiological assays, stability testing (microbiological aspects), environmental monitoring of Clean Rooms, and other miscellaneous microbiological projects.

Other duties include assuring that all microbiology laboratory activities and documentation are in compliance with relevant Company and GMP/GLP requirements, and assuring that assigned staff adhere to Company policies and procedures regarding client/project confidentiality, safety and general house-keeping.

The Lead Pharmaceutical Microbiologist position requires proven industrial experience in developing, validating and testing compendial and non-compendial microbiological test methods for pharmaceutical products. The position also includes responsibility for aseptic processing projects such as manufacture of phase-1 and phase-2 clinical batches of parenteral or other sterile products.  Candidate must have a MS in Microbiology with a minimum of 5 years or a BS in Microbiology with a minimum of 7 years hands-on experience in the pharmaceutical industry.  A minimum of 2 years leadership experience is preferred.  The successful candidate must have in-depth working knowledge of regulatory compliance requirements (GLP/GMP) and relevant FDA/ICH guidance documents; must be a self-starter with demonstrated ability to work independently and must have effective communication (oral & written) skills.

Only candidates who are US Citizens or legal residents of the USA will be considered.  Candidates residing within commuting distance of Wilmington, Delaware, will be preferred