Address
Form of workCore Hours: Monday - Friday, 8am-5pm
Purpose and Scope
The Microbiology Development and Technical Scientist I is primarily responsible for performing development activities for the Microbiology Laboratory. Provides technical expertise for microbiological testing as well as for sterility and packaging issues and ensures department compliance with new microbiology and regulatory requirements. Performs microbiological activities in support of new product development.
Essential Duties & Responsibilities
- Serve as Microbiological investigator providing technical expertise for raw materials, component, finished product, water bioburden, environmental monitoring, and endotoxin testing.
- Provide position/risk assessment papers, as required.
- Represent the Microbiology department and provide expertise when responding to governmental authorities and marketing partners during inspections.
- Continually assess development systems and procedures in the laboratory to assure they comply with business directives, cGMPs, applicable cGLPs and current industry practices.
- Investigate antimicrobial properties of new drugs and new products.
- Provide expertise for sterilization, sterility, and packaging issues.
- Assist with interpretations of bacterial and fungal identifications and keep personnel technologically informed of new microbiology and regulatory developments.
- Develop methods for development projects and new products.
- Maintain up-to-date knowledge with FDA regulations and applicable pharmacopeias in areas where product might be marketed.
- Audit contract service suppliers.
- Perform other duties as assigned.
Knowledge, Skills & Abilities
- Knowledge of pharmaceutical, food and cosmetic, and clinical microbiology in order to interpret the impact and relative importance of microorganisms when they are isolated from raw materials, component, finished product, water bioburden, and environmental monitoring samples.
- Demonstrated technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
- Skill in problem solving.
- Ability to manage multiple projects concurrently and under tight time constraints.
- Ability to clearly communicate (verbal & written) and work well with employees at all levels.
- Ability to be organized and self-directed.
- Ability to function as a team member and independently.
- Ability to use specialized computer software such as spreadsheets and graphing software.
- Mechanical/electrical ability to effect minor instrument repairs is preferred.
- Advanced skills in math-related processes, with an emphasis on statistics.
- Ability to fluently and clearly write lab notebooks, reports, and regulatory submissions.
Core Values
- The Microbiology Development and Technical Scientist I is expected to operate within the framework of Tolmar’s Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education& Experience
- Bachelor’s degree in Microbiology or closely related field with 7 or more years of Pharmaceutical laboratory work experience required.
- Master’s in Microbiology or closely related field preferred, with 5 or more years of Pharmaceutical laboratory work experience required.
- PhD in Microbiology or closely related field preferred, with 3 or more years of Pharmaceutical laboratory work experience required.
- Experience with aseptic processing, and sterility testing preferred.
Working Conditions
- Laboratory setting and office. Will be exposed to biohazard materials and pharmaceuticals.
- May require occasional holiday, weekend and/or evening work.
Compensation and Benefits
- Annual pay range $110,000 - $120,000
- Bonus eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
