Experienced Microbiologist; Pharma

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Shift
Monday through Friday, 8:00 AM - 4:30 PM

The Scientist I will perform routine and complex analytical testing on pharmaceutical and biopharmaceutical samples in a GMP-compliant laboratory environment. This role contributes to the quality control and R&D efforts by executing laboratory procedures and documenting results accurately.

Compensation: $60,000. per year

• Execute a variety of analytical tests on raw materials, in-process samples, and finished products using techniques such as HPLC, GC, UV-Vis, Karl Fischer, dissolution, and titrations.
• Prepare and analyze samples according to established Standard Operating Procedures (SOPs) and client specifications.
• Operate and maintain laboratory equipment, ensuring proper calibration and functionality.
• Document all experimental data, observations, and results meticulously in laboratory notebooks and LIMS system, adhering to cGMP principles.
• Perform calculations, analyze data, and interpret results, identifying and troubleshooting unexpected outcomes.
• Contribute to the investigation of out-of-specification (OOS) or out-of-trend (OOT) results under the guidance of senior scientists.
• Participate in method development and validation activities as directed.
• Adhere to all safety regulations, laboratory hygiene standards, and quality assurance protocols.
• Communicate effectively with team members, supervisors, and clients regarding project status and technical findings.
• Assist in maintaining laboratory inventory and ordering supplies as needed.

• Bachelor's degree in chemistry/biochemistry/chemical engineering or a closely related field; AND at least two to three (2-3) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.

• Intermediate to complex microbiological principles, practices, and techniques.
• Intermediate to Complex methods to resolve microbiological problems, questions, and concerns.
• Understanding of broad testing tools, equipment, and calibration.
• Computer applications and systems related to the work.
• Principles and practices to serving as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.
• Performing complex to specialized professional-level Microbiology duties in a variety of assigned areas.
• Laboratory experience performing and validating at least three or more of the following compendial tests. USP (AET Test) Biological Indicators, Microbial Limit Test, Sterility Test, Endotoxin, , , Sub-visible Particulate Test.
• Must have strong working knowledge of dilutions and how to scale methods appropriately if required.
• Cleanroom experience preferred.
• Ability to operate and train others in analytical instruments and manufacturing equipment.
• Training others in policies and procedures related to the work.
• Serving as a team member and the development and management of projects.
• Operating in both a team and individual contributor environment.
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
• Preparing intermediate to complex functional reports, correspondence, and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion, and prudence in working with those contacted during the work.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gases, noxious odors, and related items in a lab setting.

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