Job Description

Position Duties:

1. Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals.
2. Maintain detailed and comprehensive documentation of all work performed.
3. Stay current with the scientific literature, particularly in areas that may affect company's product line, existing processes or potential commercial opportunities.
4. Evaluate technology packages from external sources for chemical and cost-effective viability, as directed.
5. Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety.
6. Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis.
7. Provide support to QA/QC by writing analytical SOPs.
8. Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers.
9. Provide monthly report on progress of work to the department head.
10. Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management.
11. Plan and develop robust analytical methods including troubleshooting and validation, as appropriate.
12. Work closely with Synthesis group and support on routine analysis.
13. Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines.
14. Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate.
15. Work closely with R&D team to answer DMF deficiencies and customer queries.
16. Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part [click to reveal phone number]1300-1399).
17. Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes.
18. Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed.
19. Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible.
20. Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation.
21. Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes.
22. Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular.
23. Seek out opportunities for professional development.
24. Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system.
25. Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager.
26. Facilitate the training system within the R&D department in coordination with the requirements set forth by QA.
27. Other duties as assigned.

• B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline.
• Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment.
• Ability to communicate effectively through verbal, written, presentation and computer modes of expression.
• Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications).

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