Quality Control Principal Microbiologist

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Job description

Quality Control Principal Microbiologist Position:

Position Summary:

The Principal Microbiologist, Quality Control will provide technical expertise and guidance for all activities associated with Microbiology and Sterilization to support Manufacturing, Environmental Monitoring, and Pharmaceutical Research & Development projects. Position will serve as microbiology and sterilization subject matter expert for projects and engage collaboratively with cross-functional areas including production, R&D, sterilization, facilities, engineering, internal laboratories and external contract research and testing facilities. The incumbent shall contribute both strategically and tactically to ensure deliverables are met on-time and within budget.

Responsibilities: Essential Duties

• Provide microbiological and sterilization expertise to quality, manufacturing, technical services, engineering and R&D throughout all phases of project including routine manufacturing, innovation, development and technology transfer.
• Provide microbiological and sterilization expertise to quality, manufacturing, technical services and engineering for continuous improvement initiatives.
• Provide microbiological and sterilization expertise to quality to sustain and enhance (as needed) the site contamination control strategy.
• Author and review/approve assessments, procedures, technical reports and other sources of information to ensure that microbiology sampling and testing methods are consistent with compendial guidance, current industry practices and regulatory requirements.
• Coordinate method development, validation and testing with internal and external microbiology laboratories for a wide variety of testing pertaining to current processes and budgeted R&D projects.
• Author and review test protocols/data/reports for validating new products /processes to ensure conformance with established specifications and related standard operating procedures.
• Anticipate/evaluate technical problems and provide recommendations for corrective actions.
• Write, collect, organize and compile data and reports for use by upper management and to comply with regulatory requirements.
• Interface with pertinent disciplines to evaluate applicability of existing methods related to Microbiology and Sterilization.
• Review and/or develop specifications for raw materials, components and finished products.
• Evaluate, specify and justify Microbiology and Sterilization requirements for major capital projects.
• Represent company on microbiology and sterilization topics during interactions with regulatory agencies, including interface with FDA inspectors.Participate on cross-functional teams to resolve issues.
• Technical expert and responsible for implementing microbiology and sterilization validation programs for new products (including changes to containers, closures or solutions).
• Author and review non-conformance investigations related to Environmental Monitoring or Microbiological Testing of raw material/component, in-process or finished goods.
• Supports microbiological tasks for process validation.
• Trains and proactively develops the education standard of the responsible persons.
• Participates in internal and external audit.
• Participates in projects, task force jointly with internal customer departments in case the needs arise.
• Prepares trend analysis and data compilation on deviations in the production process when required.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action to assure compliance to regulatory standards and requirements.
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
• A strong scientific knowledge in areas pertaining sterilization approaches and processes (i.e. filtration sterilization, moist heat sterilization, VHP decontamination, radiation sterilization, aseptic filling requirements, isolator technology, RABS).
• Knowledge of environmental, utility and facility monitoring programs, including area classifications and process analytical technology applications. Familiarity with equipment installation and qualification and electronic data systems. Awareness of general cost structure pertinent to microbiological testing and validation.
• Strong problem solving and troubleshooting capabilities.
• Good written and verbal business communication skills.
• Must be able to work productively in a cross-disciplinary environment.

Qualifications

Expertise: Qualifications -Experience/Training/Education/Etc.

Required:

• Degree in Microbiology, Molecular Biology, Biochemistry, or a related science with significant microbiology coursework.
• Pharmaceutical industry experience at least 8-12 years in a cGMP environment.
• Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin levels, sub-visible liquid particulate matter analysis, biological indicators (manufacturing, testing & use), and cleanroom contamination control including but not limited to HEPA certification testing requirements, aseptic technique/cleanroom behavior, environmental monitoring, gowning, cleaning/disinfection, sampling methods and sampling plans.
• Demonstrated industry experience in several of the following areas: microbiological method development and validation, D & z value determination, cycle time reduction (CTR) studies, container-closure integrity testing (CCI), microbial ingress and dye penetration studies, process hold time studies, aseptic process simulations, WFI generation system validation and routine monitoring requirements, equipment cleaning validation, vaporized hydrogen peroxide and UV surface decontamination validation.
• Experience in qualification of raw materials and components used in GMP manufacturing. Generation of microbiological specifications in alignment with Compendial requirements (for US, and preferably also for EU).
• Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. Experience interacting with regulatory agencies.
• Strong technical expertise with quality risk management programs including experience with performing risk assessments related to product quality impact and establishing process controls that are critical to quality.
• Limited domestic and/or international travel may be required

Desired:

• A Ph.D. or Master's degree is highly preferred.
• Experience with manufacturing of small and large volume parenterals is preferred.
• Experience with Advanced Production Technology e.g. Restricted-Air Barrier Systems, Blow-Fill-Seal, Form-Fill-Seal and Isolator Technology.
• There's a 15% Sign-On Bonus as well!!

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.