ARx Pharmaceutical Scientist

Job Title: R&D Formulation Scientist

Job Summary:

Responsible for the design and development of new products, new formulations, creation of new technologies, and improvements to existing products.

Essential Functions:

• Project Design & Strategy: Defines project design & strategy consistent with application requirements; reviews and shares with project team members and others in the organization as appropriate.
• Formulation Development: 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.
• Experimentation & Testing: Designs & conducts experiments on lab and production scale; draws valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references.
• Test Methodologies & Requirements: 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.
• Efficient Work Practices: 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.
• Troubleshooting & Problem-Solving: Efficiently troubleshoots and solves technical problems.
• Production-Scale Processes: Participates in the design and specification of production-scale processes and validation thereof.
• Cross-Functional Teams: 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.
• Literature & Patent Research: Researches literature and patents as needed to effectively assure freedom-to-operate and otherwise support projects.
• Lab Notebook & Record Keeping: Maintains up-to-date, well-organized, clear and accurate information in lab notebooks and design records consistent with established company & divisional practices.
• Office & Laboratory Environment: Supports and contributes to maintaining office and laboratory environment consistent with LEAN 6S and all regulatory requirements.
• Customer Interactions: 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.
• Patenting Technology: Recognizes opportunities for and participates in patenting technology yielding sustainable competitive advantage.
• Pharmaceutical & Drug Delivery Technologies: Maintains a current awareness of pharmaceutical and drug delivery technologies to build expertise and applies same to benefit business.
• Compliance & Training: Ensures up-to-date compliance with all training requirements; understands overall business strategy and plans while also working to execute responsibilities in accordance thereof.
• Continuous Improvement: 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.
• Waste Handling Procedures: Responsible for following all applicable waste handling procedures.

Additional Responsibilities:

• Benchmarking Equipment & Systems: Benchmarks equipment and systems.
• Other Duties: Performs other related duties as assigned.

Job Specifications:

• Education & Experience: BS in Pharmaceutical Sciences, Chemistry, or Polymer/Materials Science with a minimum of 3 years of experience in pharmaceutical and/or drug delivery systems formulation; MS with 1-3 years of experience, or a PhD with 0-2 years of experience is preferred. Polymer formulation and mixing process experience in drug delivery required with coatings experience preferred; oral solid dosage form experience required;
• Clinical Trials Regulations: Knowledge of and experience with cGMP, 21CFR Part 211 required; QbD, PAT, & ICH experience preferred.
• Communication Skills: Must communicate fluently in English and have excellent communication and interpersonal skills.
• Independence & Prioritization: Capable of performing duties independently with limited supervisory direction.
• Multitasking: Ability to effectively manage multiple priorities.
• Chemical Analytical Techniques: Familiarity and aptitude with chemical analytical techniques, i.e. liquid/gas chromatography, FT-IR etc. and associated data analysis.
• Statistical Software & Experimental Techniques: Working knowledge of statistical-based software and experimental techniques (DOEs).
• Confidentiality: Ability to maintain confidentiality.
• Professional Conduct: Ability to conduct self in a professional manner & maintain appearance accordingly.
• Computer Literacy: Functioning capability with standard computer software.