ARx Associate Scientist III

Job Summary:

• Assist in preparation, testing, and analysis of pharmaceutical products in compliance with regulatory and quality standards.
• Support R&D and operations during tech transfer, manufacture of validation batches, clinical batches. Leading scale up activities, and process development.
• Responsible for the design and development of new products, improvements to existing products.

Essential Functions:

• Ensure equipment calibration and maintenance, manage chemical inventory, and assist in lab experiments, batch manufacturing, physical evaluation.
• Understand company processes and equipment and efficiently lead scale up/ tech transfer activities.
• Lead in manufacture of batches (Lab / pilot / scale up/ clinical) in Lab and GMP environment.
• Understand project design and build strategy consistent with application requirements by defining QTPP, outlining CQAs, evaluating CMAs and establishing CPPs for different formulations. Reviews and shares updates with internal project teams and external clients as appropriate.
• Develop unique formulations starting from selection of raw materials, identifying manufacturing processes, optimizing process parameters and experimental evaluation of prepared formulations (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.
• Anticipates and proactively addresses potential lab development, scale-up, validation, clinical, regulatory, and commercial issues during development.
• Efficiently troubleshoots and solves technical problems.
• Represent company at trade shows and conferences and present with technical data and expertise.
• Prepare test samples for and carry out physical testing, dissolution studies, permeation studies as outlined by scientist(s)
• Develop testing methodologies for evaluating dosage forms for its physiochemical properties, release and permeation profiles and evaluate test articles using the same.
• Draws valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references.
• Maintains up-to-date, well-organized, clear, and accurate information in lab notebooks and design records consistent with established company & divisional practices. Ensure timely review of all notebook pages.
• Author / review/ edit SOP(s) for new / existing equipment and processes.
• Write Project reports and presentations for project updates to internal teams, external client, and regulatory bodies
• Ensure up-to-date compliance with all training requirements.
• Maintain a clean safe, and organized lab environment in accordance with health and safety guidelines.
• Follow all waste handling procedures.
• Support and contribute to maintaining office and laboratory environment consistent with LEAN 6S and all regulatory requirements.
• Understand overall business strategy and plans while working to execute responsibilities in accordance thereof.
• Perform other duties and responsibilities as assigned

Job Specifications:

• Master’s degree in Pharmaceutical/ Medical Sciences/ Chemistry or equivalent with 0 to 4 years’ experience in pharmaceutical product development OR Ph.D. in pharmaceutical / biomedical sciences with 0 to 2 years’ experience with focus on transdermal / topical/ oral / buccal delivery systems.
• Technical understanding of processing equipment pertaining to mixing, coating, packaging and lyophilization preferred
• Ability to learn quickly and aptly.
• Seasoned with manufacturing equipment and processes specifically to mixing, coating and other processes.
• Experienced with cGMP, 21CFR Part 211, QbD, PAT, ICH & ISO.
• Capable of performing duties independently with limited supervisory direction.
• Familiarity and aptitude with chemical analytical techniques and associated data analysis
• Communicate fluently in English with excellent interpersonal skills.
• Ability to maintain confidentiality.
• Functioning capability with standard computer software (Microsoft Office, internet & database searching, email, etc.) Oracle ERP systems.