R&D Manager – Microbiology | Job ID: 2810

Position Summary:

Our client is looking for an R&D Manager-Microbiology to lead and provide effective guidance for a team focusing on developing products in the drug (OTC, DIN, NHP), medical devices, cosmetics, disinfectants (EPA, DIN), and general household products areas. Primarily, the role supports new market launches with input across all facets of project progression, including scientific insights, prototype assessment, and registrEfficient resource deployment regarding workload, capacity, and resources in partnership with key stakeholders.

Manage the laboratory in terms of budget for supplies/equipment, improve process workflows, and ensure employee health and safety.

Develop and grow a dedicated group of microbiologists.

Responsibilities:

• Manage performance metrics. Ability to assess individual performance and behaviors against PDI’s core values.
• Lead small cross-functional project teams in various workstreams (new technology implementation, cost-savings, compliance work, etc.)
• Manage external vendors for service contracts, Master Service Agreements, and NDAs.
• Partner with Industry and/or Academia to manage work overflow and investigational studies. 
• Actively seek new partnerships in both technologies and testing support. Maintain an ongoing search for new microbiology technologies which can be used in existing products for cost reductions or performance improvements. 
• Author, review, and approve technical protocols and reports for microbiological method suitability, validation, and verification. 
• Collect, analyze, and interpret information, whether test data, published scientific papers, or raw material vendor-supplied information. Demonstrate the ability to absorb and reduce such information to practical actions and recommendations.
• Lead and action on items from various quality systems, such as change controls, CAPAs, OOS, etc. as needed.
• Participate in troubleshooting equipment, processes, or other technical issues as needed.
• Provide microbiology subject matter expertise to cross-functional departments to aid in developing a long-term microbiological strategy in a competitive landscape.
• Act as the SME on fundamental microbiology questions with internal and external regulatory representatives.
• Cross-functional communication across Quality Control, Quality Assurance, Regulatory, and Product Development.

Qualifications:

Education:

• Scientific Degree in Microbiology or related field, Masters or higher, preferred.
• Regulated background in either FDA (preferred) or EPA environment.
• Rich microbiology understanding, especially in USP microbiological testing requirements.
• Understanding regulatory requirements for drug substances and products and pharmaceutical development guidelines established in the USP, ICH guidelines, etc.
• Demonstrated technical leadership and technical abilities, including knowledge of modern microbiology techniques, laboratory equipment, and methods.
• Demonstrated understanding of GDP/GMP/GLP.

Experience:

• 7+ years of microbiology R&D working experience, and solid working knowledge of FDA/EPA regulations with respect to development required.
• Laboratory Management.
• Team Management.
• Resource/Project Planning.
• Previous experience of wipes, the Healthcare or Food Service industry, and/or sterile/non-sterile pharmaceutical manufacturing is advantageous.

SKILLS/ABILITIES:

• Demonstrated ability to lead others.
• Excellent communication skills (verbal / written / presentation). 
• Highly motivated to work as a member of a nimble team. Embraces change and risk and exhibits flexibility.
• Exhibits excellent organization, planning, and multi-tasking skills; able to handle multiple projects/tasks simultaneously.
• Able to influence cross-functional partners to gain support and alignment to ideas.
• Steadfast under pressure.
• Computer literate (MS 365, Electronic Notebook, LIMS).
• About 10% Lab and 90% office environment

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