Lead Microbiologist | Cary, NC

Biotech/Pharmaceutical jobs refer to career opportunities within industries that focus on developing drugs and medical technology derived from living organisms and cellular and biomolecular processes. These roles occupy a diverse ecosystem ranging from research and development (R&D) to regulatory affairs, manufacturing, and sales. Key characteristics include a strong emphasis on innovation, stringent regulatory environments, the need for advanced degrees or expertise in life sciences, and a commitment to improving patient health outcomes. As these fields are constantly evolving with the advancement of science, professionals often engage in ongoing learning and adaptation to new scientific discoveries and medical needs.

of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.

Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate.

Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities. Author and/or revise procedures/methods, as appropriate.

Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.

Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Proactively

address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Basic understanding of instrument operations and troubleshooting skills in multiple techniques Ability to identify aberrant/out of spec data and limited interpretation of data expected Excellent written and verbal communications skills with internal and external customers

the incumbent will act as a primary technical lead interfacing with customers, writing protocols and communicating with the Microbiology Manager and other internal stakeholders to ensure incoming projects are ready to execute. Primary duties include performing microbiological method development and verification, testing of raw materials and sterile and non-sterile medical dosage forms, and general support activities within the Microbiology group in the Quality Control Department.

An individual in this role functions as a microbiology technical lead, interacts with external and internal customers for project support, and mentors or provides technical guidance to junior analysts. Responsibilities

also include coordinating, performing and/or supporting instrument/equipment qualification activities, as well as associated maintenance and calibration programs.

The individual will author and/or revise procedures/methods, as appropriate. II. Essential Functions: Plan and perform method development/validation, routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance. Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct

of project activities and to assure project timeline understanding and deliverable are met, as appropriate.

Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities. Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable. Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented.

Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. III. Position Requirements: Education or Equivalent: Bachelor's degree in chemistry or closely related physical science. Experience: : Education: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience Industry experience as a microbiologist, strong leadership and project management skills, and previous supervisory experience are desirable.

Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Basic understanding of instrument operations and troubleshooting skills in multiple techniques Ability to identify aberrant/out of spec data and limited interpretation of data expected Excellent written and verbal communications skills with internal and external customers -------------------------------------------------------------------------------------- Thanks & Regards Kiran comear Senior Recruiter Email: xyz X@ Desk Number: 732-412-xyz X Ext 259 Direct Number: 732-398-xyz X Website: Address: 517 Route 1 South, Suite 1115 Iselin, NJ 08830 In my absence, you may contact Kowshik Lead 732-627-xyz X xyz X@

routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.

Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate. Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities.

Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.

Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability

to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Education & Experience: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience