Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE
PDI is seeking a Microbiology R&D Manager to lead and provide effective guidance for a team with a focus on developing products in the drug (OTC, DIN, NHP), medical device, cosmetic, 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 registration testing to meet regulatory requirements. In addition, this role will be developing studies that enhance PDI's current portfolio to provide a competitive edge in the healthcare and food service marketplace.
The Manager oversees the work within their group and external service providers to ensure that the goals of the project teams are met in a timely, cost-sensitive, and phase-appropriate fashion. The incumbent is responsible to align microbiology development activities with project teams, regulatory development strategies and timelines and build the technical capabilities and collaborative scientific and operational partnerships needed to effectively carry out the department mission in a R&D/GMP/GLP compliant quality standard as warranted.ESSENTIAL FUNCTIONS AND BASIC DUTIES
- Efficient resource deployment regarding workload, capacity, and resourcing 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.
- 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.)
- Mange 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 it be 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 the development of 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.
- Demonstrate year on year increase in productivity.
- Effective communication and cooperation with other team members.
- Elevation of the Microbiology team among the R&D community and business as a whole.
- Ensure implementation of robust processes and procedures that maintain compliance to all applicable GxP regulations, Company and Department procedures/policies
- Recruit, develop and retain an effective technical team; act as a model for the R&D organization.
- Effectively manage budget for Microbiology R&D cost center
- 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 of regulatory requirements for drug substances and drug products as well as pharmaceutical development guidelines established in the USP, ICH guidelines, etc.
- Demonstrated technical leadership and technical abilities, including working knowledge of modern microbiology techniques, laboratory equipment and methods.
- Demonstrated understanding of GDP/GMP/GLP.
- 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 advantageous.
- 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 at the same time
- Able to influence cross-functional partners to gain support and alignment to ideas
- Steadfast under pressure
- Computer literate (MS 365, Electronic Notebook, LIMS).
- Approximately 10% Lab and 90% office environment
- No significantly hazardous or unpleasant conditions
- Requisition Number: RDMAN005553
- Job Category: Managers
- Schedule: Full-Time