R&D Manager | Job ID: 2799
Analytical R&D Manager to lead and provide effective guidance for a team focusing on developing products in the drug (OTC, DIN, NHP), medical device, cosmetic, disinfectants (EPA, DIN), and general household products areas. The Manager will direct method development, method validation, method transfers, routine stability testing, and investigational testing for chromatographic, spectroscopic, and potentiometric/colorimetric titration methods. Additionally, this role will serve as the Chemical Hygiene Officer for the entire cross-functional laboratory.
- Efficient 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.
- Partner with Industry and/or Academia to manage work overflow and investigational studies.
- Actively seek new partnerships in both technologies and testing support.
- Author, review, and approve technical protocols and reports for method development, validation, and transfers.
- Lead and act on items from various quality systems, such as change controls, CAPAs, OOS, etc. as needed.
- Oversee internal and external Stability Programs.
- Manage external vendors for service contracts, Master Service Agreements, and NDAs.
- Participate in troubleshooting equipment, processes, or other technical issues as needed.
- Lead small cross-functional project teams in various workstreams (new technology implementation, cost-savings, compliance work, etc.)
- Develop and grow a dedicated group of scientists.
- Manage performance metrics. Ability to assess individual performance and behaviors against PDI’s core values.
- Cross-functional communication across Quality Control, Quality, Regulatory, and Product Development.
- Function as department Chemical Hygiene Officer. Lead a cross-functional team through monthly audits, completing action items, implementing process improvements, and evaluating hazards. Willing to train the right person for this role.
- Advanced Degree in Chemistry
- Regulated background in either FDA or EPA environment
- Rich Chemistry knowledge and understanding of chemical properties, interactions, and analysis methods.
- In-depth technical knowledge of various analytical techniques, including LC, GC, MS, NIR, FTIR, titration, etc.
- Demonstrated understanding of GDP/GMP/GLP.
- Strategic thinking in a competitive landscape.
- 7+ years of R&D working experience in Laboratory Team Management and resource/project Planning
- Previous experience within the Healthcare field advantageous.