Responsible for the design and development of new products, creation of new technologies, and improvements to existing products
- Defines project design & strategy consistent with application requirements; reviews and shares with project team members and others in the organization as appropriate.
- Develops formulations and related product constructions including selection of raw materials, experimental evaluations (e.g. compatibility, stability, performance, etc.) and specifications; frequently works on more than one project at a time with number depending on scope and timing.
- Designs & conducts experiments on lab and production scale; draws valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references.
- Defines test methodologies and requirements; prepares test samples and conducts tests on raw materials, in-process intermediates, and/or finished products as required to support programs; develops new tests as necessary to support development or product improvement projects.
- Fulfills responsibilities in an efficient and effective manner; makes critical distinctions in support of prioritizing and organizing work; anticipates and proactively addresses potential lab development, scale-up, validation, clinical, regulatory and commercial issues during development.
- Efficiently troubleshoots and solves technical problems.
- Participates in the design and specification of production-scale processes and validation thereof.
- Contributes and represents R&D while serving on cross-functional teams chartered to develop and commercialize new drug delivery products; interacts effectively fulfilling functional responsibilities, collaborating with functional counterparts & customers to assure overall project success.
- Researches literature and patents as needed to effectively assure freedom-to-operate and otherwise support projects.
- Maintains up-to-date, well-organized, clear and accurate information in lab notebooks and design records consistent with established company & divisional practices.
- Supports and contributes to maintaining office and laboratory environment consistent with LEAN 6S and all regulatory requirements.
- Interacts with customers as needed to support projects; behaves in a respectful and professional manner and able to earn & maintain the confidence of associates and customers.
- Recognizes opportunities for and participates in patenting technology yielding sustainable competitive advantage.
- Maintains a current awareness of pharmaceutical and drug delivery technologies to build expertise and applies same to benefit business.
- Ensures up-to-date compliance with all training requirements; understands overall business strategy and plans while also working to execute responsibilities in accordance thereof.
- Makes identifiable and beneficial contributions to continuous improvement; performs all duties safely and consistent with established company and divisional procedures and guidelines; actively complies with and endorses department, divisional and company objectives.
- Responsible for following all applicable waste handling procedures.
- Benchmarks equipment and systems.
- Performs other related duties as assigned.
- B.S. in Pharmaceutical Sciences, Chemistry, or Polymer/Materials Science
- Minimum of 4 years experience in pharmaceutical and/or drug delivery systems formulation; advanced degree and/or more extensive experience preferred.
- Polymer formulation and mixing process experience in drug delivery required with coatings experience preferred; oral solid dosage form experience required;
- Knowledge of and experience with cGMP, 21CFR Part 211 required; QbD, PAT, & ICH experience preferred.
- Must communicate fluently in English and have excellent communication and interpersonal skills.
- Capable of performing duties independently with limited supervisory direction.
- Ability to effectively manage multiple priorities.
- Familiarity and aptitude with chemical analytical techniques, i.e. liquid/gas chromatography, TGA, DSC, FT-IR etc. and associated data analysis.
- Working knowledge of statistical-based software (Minitab) and experimental techniques (DOEs).
- Ability to maintain confidentiality.
- Ability to conduct self in a professional manner & maintain appearance accordingly.
- Functioning capability with standard computer software (word-processing, spreadsheets, internet & database searching, email, etc.) and Oracle ERP systems.