How will you make an impact?

Provide moderately complex analyses in a microbiology lab environment within defined procedures and practices. Perform analytical methods for moderately sophisticated testing on raw materials, samples, stability, and production intermediates. Support internal development and/or manufacturing operations. Make detailed observations and reviews, documents, and communicates test results; recommend solutions. Typical work hours are 8:00am - 4:30pm weekdays, with flexibility for evenings and on call weekends.

What will you do?

Conduct moderately sophisticated microbiological testing of in process products and finished products by internally developed and compendial test methods.

Perform validated test methods for Bioburden, Bacterial Endotoxin Testing, Particulate Matter, Sterility, and Water testing.

Develop and validate new test methods including existing and new technologies.

Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems; recommend solutions.

Work with Quality assurance to drive RCA for completion of Investigations and required corrective actions.

Maintain and troubleshoot analytical instrumentation as needed.

Clearly and accurately communicate the results of work by crafting documentation of the testing/analysis and acquired results. Record and report results of analysis in accordance with prescribed lab procedures and systems.

Prepare and assist in filing regulatory documents in support of internal projects.

Provide communications with outside departments, corporate sites, agencies, and clients.

Write SOPs and other instructional documents.

Clean and coordinate work area, instrumentation, and testing materials.

Maintain stock of commodities needed for testing support.

Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the vital compliance status required by company and facility standards.

How will you get here?

Education

Bachelor degree required, preferably with a concentration in Microbiology, Biology, or Chemistry.

Experience

5-6 years of proven experience in a pharmaceutical microbiology lab performing tests or analyses for pharmaceutical raw material, in process product, and finished product samples strongly preferre.

Experience with method development and validation of microbiological tests in a pharmaceutical laboratory highly preferred.

Experience with common office software and data acquisition systems. Experience with LIMS, SLIM, Trackwise, or Documentum a plus.

Experience in interaction with clients, communicating OOS results and investigations preferred.

Knowledge, Skills, Abilities

• Sophisticated problem-solving skills and logical approach to solving scientific problems.
• Above average interpersonal and communication skills (both oral and written- legible handwriting).
• Strong presentation skills to present information to customers, clients, and other employees.
• Strong Mathematical, Time Management and Organizational Skills
• Highly organized, detailed and self-motivated
• In depth knowledge and understanding of microbiological methods and aseptic technique.
• Sophisticated knowledge of quality and regulatory requirements in the pharmaceutical industry.
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Ability to write SOPs, simple protocols, and reports.
• Ability to respond to common inquiries or complaints from customers or regulatory agencies.
• Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
• Adaptable and Capable of working within a team as well as independently
• Knowledge of qualitative and quantitative microbiological Tests.

Core Proficiencies:

Put the Customer First - Think and act with a customer-centric mentality to deliver outstanding customer experiences. Be Responsible For Your Results - Take personal accountability for all you do and always exercise good judgement. Find a Better Way Every day - Be intellectually curious and embrace Practical Process Improvement (PPI).

Physical Requirements:

The position requires basic physical coordination, including walking, standing, and occasional bending or kneeling. It also involves light to medium lifting and carrying (10-35 pounds), as well as using your hands and fingers for typing and grasping. Good vision is needed to use a computer and read materials, and the ability to sit, reach, talk, and hear for long periods of time is important.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!