The Senior Microbiologist’s primary responsibility is to serve as the technical subject matter expert with regards to environmental control in an aseptic processing operation, and all other microbiology testing related to customer products and GRAM operations. The responsibilities of this position require effective cross-functional interaction at all levels, working within and leading teams to ensure compliance and drive continuous improvement of environmental control and microbiology testing.
- Industry Knowledge:
- Maintain a complete and up-to-date understanding of current industry regulations, guidance documents, standards, best practices and expectations with regards to aseptic manufacturing, environmental control and monitoring, and microbiology testing.
- Ensure all microbiology personnel are educated in the most current industry trends, best practices and expectations with regards to aseptic manufacturing, environmental control and monitoring, and microbiology testing.
- Ensure microbiology processes and procedures remain in compliance with SOPs, CFR, FDA, DEA and cGMP requirements, and industry best practices; propose and implement process / procedure changes as needed to ensure alignment with requirements.
Process Support / Technical Activities:
- Lead and/or actively participate in technical projects pertaining to microbiology testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc.
- Perform method validation/ suitability for microbiological tests, specifically bioburden and endotoxin testing.
- Perform trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable.
- Investigate and document any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective / preventive actions.
- Perform Laboratory Investigations for any out of specification results.
- Plan and implement corrective and preventive actions (including procedure and test method revisions), and assist/measure the effectiveness of such changes.
- Assess process / procedure changes proposed by others for potential impact on environmental monitoring / microbiology testing processes.
- Participate in cross-functional meetings and training sessions with manufacturing operations.
Laboratory Support Activities:
- Maintain qualification for all microbiology sampling procedures and test methods; perform testing as needed to support business needs.
- Coordinate and/or conduct training for new laboratory personnel; provide technical assistance to laboratory personnel as needed.
- Coordinate with contract testing laboratories and experts as needed.
- Review process and testing documentation as needed to ensure complete and accurate records are maintained.
- Assist in the conduct of vendor audits as a microbiology subject matter expert, as needed.
- Participate in client and regulatory audits as a microbiology subject matter expert, preparing documents for review and speaking to GRAM processes and procedures to answer auditor questions.
- Other relevant duties as assigned.
Microbiologist with a minimum of 6 years of experience within a pharma, biopharma and/or biotech manufacturing environment (prefer aseptic filling environment experience). Must have strong interpersonal skills and ability to effectively work cross-functionally at all levels. The person also must be able to communicate professionally with management, vendors, clients and regulatory agencies. BS or BA in a scientific discipline and 6+ years or MS and 3+ years of experience in a Microbiology laboratory supporting an aseptic manufacturing process.
- Ability to interpret and translate Quality standards to ensure effective implementation.
- Strong written and verbal communication skills, as well as demonstrated effective presentation skills.
- Organized, self-motivated, individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment
- Ability to work well in a cross-functional team environment
- Must have proficient computer skills in Microsoft Word, Excel and Outlook. Experience with statistical analysis programs (e.g. Minitab, JMP) a plus.
If you would like to be considered, please submit your resume on our careers page.