Summary of Responsibilities:
The Senior Microbiologist is responsible for the microbiological testing in support of manufacturing activities under cGMP conditions. This individual works under minimal supervision and is expected to interpret data from both process and equipment validation in partnership with Engineering and R&D. The lists of activities vary.
Strategic Focus Areas:
Anticipate future consequences, explore alternative scenarios, communicate and execute plans.
- Function as coach/mentor within the laboratory
- Perform and review bioburden, sterility, and endotoxin testing of raw materials, in-process samples, bulk intermediate, and finished products including stability samples
- Write and revise internal SOPs and test methods
- Author/review excursion, technical, and summary reports (i.e. nonconformances, planned deviations, OOS, CAPA, etc.) in support of the Quality System
- Collaborate in authoring and/or perform method validations including summary findings for new products and operations initiatives
- Present microbiological and validation data
- Prepare responses to internal audit findings
- Collaborate with outside vendors to meet organizational objectives
- Maintain and develop work schedules with internal team members
- Train less experiences staff and cross-functional partners (e.g. gowning training for ISO-5, ISO-7, ISO-8 manufacturing spaces)
- Perform semi-annual Media Fill Testing, Review, and Inspection.
- Other duties and projects as assigned
Works on complex problems requiring in-depth analysis and evaluations of factors to strategically address organizational objectives. Exercises sound judgment when partnering to define practices and policies. Functions as a SME on routine work.
Experience, Knowledge, and Skills Required:
- Requires BS in microbiology, biology or related science with more than 5 years’ experience or MS in microbiology, biology or related science at least 3 years’ experience
- Experience in the pharmaceutical industry with microbiological testing such as:
- Sterility & bioburden
- New product validation
- Microbial identification
- Gram staining
- Bacteriostatic and growth promotion assay
- Purified water testing
- Experience with cGMP, GLP, and GDP
- Experience in environmental monitoring of clean room, aseptic media fill evaluation
- Excellent verbal and written communication skills
- Knowledge of FDA regulations and ISO requirements (9001, 13485 and 17025)
- Proficient use of Microsoft Office Suite
- Able to keep a safe working environment
Desired Experience, Knowledge, and Skills:
- Ph.D. in microbiology, biology or related science with 0 – 2 years’ experience
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.