Sr. Scientist I Product Development

Description

Senior Scientist I (Product Development) for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Carry out responsibilities in compliance w/ org's policies + procedures + CGMP, FDA, DEA, + OSHA regs. Design, plan + conduct prod dev activities incl pre-formulation, formulation, process development, + scale up studies of complex projects to ensure sci standards met. Document study details in lab notebooks + batch records compliant w/ GDP + CGMP. Summarize data, discuss results, + make conclusions in tech reports. Create invention disclosures, collab w/ int + ext counsel to perform patent landscape analysis, draft patent apps + respond to office actions. Utilize risk-based approaches + QBD principles in guiding pharm development + identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) + control strategies. Use problem solving tools to troubleshoot. Design + conduct physical + chem characterization in liaison w/ analytical teams. Perform critical data analysis using statistical tools, incl stability analysis. Plan, coordinate, + manufacture GMP pilot + pivotal batches, incl protocols, master batch records + reports. Liaise, coordinate + manage product development activities w/ external labs, CROs, + CDMOs incl CGMP manufacturing activities. Collab closely w/ other functions w/in + outside R+D to meet project timelines. Present + update project status + issues/challenges to mgmt. Ensure cleanliness + function of product development lab areas, equip, + instruments properly maintained. Support review of qualification docs for process equip. Support tech services + ops to troubleshoot scale up + commercial processes. Author regulatory submission docs for New Drug Applications + Abbreviated New Drug Applications (NDAs/ANDAs), supplements, annual reports + IR/CRL responses, covering pharm development + manufacture, incl pharmaceutical development reports. Collab w/ + assist Regulatory Affairs w/ coordination + submission of Pivotal batches to CROs. Create + revise product development SOPs. Collab w/ QA on investigations, CAPAs + change controls to ensure timely closure. Train new employees + mentor lower level scientists. May undergo background checks incl drug screen.

Requirements

Must have Bach in Pharm, Pharm Sci, or rel sci field, 10 yrs rel exp in pharmaceutical formulation and product development, and required skills (10 yrs exp). In the alternate, must have Master's in Pharm, Pharm Sci, or rel sci field, 8 yrs rel exp in pharmaceutical formulation and product development, and required skills (8 yrs exp). Alternatively, must have PhD in Pharm, Pharm Sci, or rel sci field, 3 yrs rel exp in pharmaceutical formulation and product development, and required skills (3 yrs exp). Required skills: designing and conducting pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms, including oral controlled release solids; using Quality-by-Design and risk-based approaches; working with FDA and CGMP regulations and guidance, and OSHA requirements; technical writing, including SOPs, investigations, protocols, reports and submission documents; training and mentoring lower level scientists; and Microsoft Office. All candidates also must have 6 months exp handling controlled substances. Any suitable combination of education, training, or experience is acceptable.