Senior Scientist, Microbiology

Description:

The Senior Scientist, Microbiology is responsible for testing incoming samples from Amneal facilities and performing scheduled environmental monitoring. This role ensures all work complies with cGMP requirements, analytical procedures, and applicable SOPs. The scientist will thoroughly review and sign off on notebook records, testing data, instrument calibration records, certificates of analysis, and other laboratory documentation. They will also evaluate and approve records related to method validation, transfers, investigations, complaint samples, process validations, and special projects. Discrepancies must be reported promptly to laboratory management for resolution. The role includes participation in analytical testing and occasional leadership of laboratory activities. Responsibilities also involve verifying calibration status of instruments and usability of reference standards. The Senior Scientist, Microbiology will collaborate with laboratory personnel to correct records and ensure compliance across all microbiological operations.

Essential Functions:

• Validates and tests raw material, in process samples, finished product and stability samples for microbial qualitative and quantitative testing as per current USP and in house methodology for Total Aerobic Count, Total Yeast and Mold Count, and specified organisms e.g. e. coli, Salmonella spp., S. aureus, P. aeruginosa, etc..
• Validates and performs preservative challenge test. Performs all the R&D-related projects as required.
• Investigates and documents Microbial Data Deviation (MDD) results.
• Creates and maintains laboratory records documentation (notebooks and computer based); documents exact steps followed during analysis execution. Performs all analysis according to written methods, or compendial methods as applicable, using analytical techniques as identified in Standard Operating Procedures (SOPs).
• Samples and tests purified water as raw material for total heterotrophic count and coliforms.
• Performs environmental monitoring/cleaning validation of facility (air and surfaces) and performs identification and interpretation of pharmaceutical significance of isolated from different manufacturing environment.
• Prepares and executes protocols, method verifications/validations protocols protocols as and when required.

Additional Responsibilities:

• Performs QC checks on prepared media e.g., growth promotion, indicative and inhibitory properties, pH, sterility. Sterilizes glassware and other items.
• Decontaminates used/contaminated objects.
• Prepares and dispenses culture media.
• Performs intra laboratory quality control checks for all equipment.
• Responsible for operation of autoclave and performs control procedures, such as bio indicator checks and temperature verification.
• Assists other microbiologists as required.
• As and when needed, assists Supervisor for handling non-routine special projects requiring activities in the laboratory.
• Ensures that expired media, chemicals and reference organisms are removed and replaced in the lab.
• Interacts with newly hired laboratory technicians or scientist for providing hands on training on analytical techniques and laboratory instrumentation.

Education:

• Bachelors Degree (BA/BS) Microbiology or related field - Required
• Master Degree (MS/MA) Microbiology or related field - Preferred

Experience:

• 5 years or more in With a Bachelor's degree, microbiological testing of pharmaceuticals in a regulated environment.
• 3 years or more in With a Master's degree, microbiological testing of pharmaceuticals in a regulated environment.

Skills:

• Must be precise and consistent in day-to-day analysis, easily trainable, and ready to learn. - Advanced
• Must be able to read and understand analytical and microbiological procedures. - Advanced
• Must be able to effectively communicate results, problems and issues, verbally as well as in writing. - Intermediate
• Must be able to assume a role of a leader in team environment as and when required. - Intermediate
• Must be computer literate. Must be willing to work extended hours, including weekends, as and when required. - Intermediate
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignment. - Advanced
• Should be able to manage the work in fast-moving environment. - Intermediate
• Must be able to maintain clear and concise laboratory records and communicate clearly both within and outside the department. - Advanced
• Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Intermediate
• Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Advanced

Specialized Knowledge:

• Basic knowledge of cGMP and aseptic tehniques.
• Must possess a working knowledge about microbiology and related tsts as handling of sterile media, organisms, techniques to avoid contamination and perform analyses.
• Must be proficient in method validation/verification for and preservative challenge test.
• Must be able to follow analytical techniques such as weighing, transfer of media in flasks, quantitative addition of additives during media reparation, mathematical calculations involved in preparation of tests and results computations.
• Must be able to follow compendial ((USP/EP/JP/BP) procedures for microbiological techniques.
• Must have the ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner.
• Must be able to identify trends in the data.

The base salary for this position ranges from $90,000 to $120,000 per year.   Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.