Microbiology Development and Technical Specialist; Onsite

Core

Hours:

Monday - Friday, 8am-5pm

Purpose and Scope

The Microbiology Development and Technical Specialist 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 Specialist is expected to operate within the framework of Tolmar's Core Values:
  • Center on People: We commit to support the wellbeing of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise wide mindset that lifts the whole organization.
  • Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
  • Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
  • Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk taking that drives better ways of working.
  • Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability &…