Microbiologist (Micro) I, II, & III in Piscataway, New Jersey at Kashiv Biosciences LLC

Position Summary

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsidiary, Kashiv BioSciences Private Limited, in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Microbiologist reports to and takes direction from Microbiology Management. This individual works closely with Management on department strategy and work projects.

Essential Duties & Responsibilities

• Coordinates microbiological testing, release of product, and testing for validation protocols.
• Performs organism identification.
• Performs technical review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets microbiological cultures and other related tests, including but not limited to environmental monitoring, sterility tests, growth promotion, and microbial limits tests.
• May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
• Reviews and approves environmental monitoring data, laboratory equipment, and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Essential Duties & Responsibilities

• Coordinates microbiological testing, release of product, and testing for validation protocols.
• Performs organism identification.
• Performs technical review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets microbiological cultures and other related tests, including but not limited to environmental monitoring, sterility tests, growth promotion, and microbial limits tests.
• May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
• Reviews and approves environmental monitoring data, laboratory equipment, and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Position Requirements and Qualifications

Minimum Qualifications:

Education:

• A 4-year Bachelor's degree, preferably in a science or engineering discipline

Experience:

• Previous experience for Micro I (0 to 2 years or more), Micro II (2 to 5 years or more), and Micro III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
• Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
• Certification from professional organizations such as ASQ and ISPE is desired but not required.

Preferred Qualifications:

SPECIALIZED KNOWLEDGE AND SKILLS:

• Other special projects and/or duties may be assigned by Management.
• Trains other Microbiologists on Department methods, processes, and procedures.
• Works with other departments to accomplish Company goals or projects.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and/or correspondence.
• Ability to speak effectively before groups or employees of the organization.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Compensation:

• Micro I Specialist – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
• Micro II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
• Micro III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Typing, desk work, and plant auditing.
• Must be able to read, write, and understand English.
• Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.
• General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.