Experienced Microbiologist; Pharma

Shift:

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Job Summary

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

Job Responsibilities

* 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.

Job Qualifications

Education and experience

* 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.

Required knowledge and skills

* 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, < 62>
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…