Scientist II, MS&T
5 days ago
Lakewood
Work Location: Ocean County, New Jersey Summary: Seeking a Scientist II to support manufacturing science and technology (MS&T) activities for pharmaceutical products, including parenteral and nasal formulations, from scale-up through commercialization and process improvement. The role involves technical support, process development, and cross-functional collaboration. Responsibilities: • Execute MS&T activities for pharmaceutical products, supporting scale-up, commercialization, and ongoing process improvements with limited supervision., • Develop expertise in drug development processes, regulatory requirements, and CMC strategies to support project objectives., • Ensure compliance with safety, environmental, and quality standards, maintaining and following all relevant SOPs and regulations., • Collaborate with cross-functional teams, external partners, and participate in technical discussions to support project deliverables and client communications., • Prepare and review project protocols, technical documents, and proposals, ensuring accurate and timely completion of assigned tasks., • Provide technical guidance for both commercial and development-stage products through written communications and reports., • Analyze and trend process data to ensure specifications are met, including conducting Process Capability Analysis and supporting batch record accuracy., • Support regulatory audits, maintain flexibility in work schedule, and perform additional duties as assigned to meet business needs. Qualifications: • Bachelor's degree in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering, or related field with 3-5 years of hands-on MS&T or Product Development experience., • Master's degree in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering, or related field with 1-3 years of hands-on MS&T or Product Development experience., • PhD in Pharmaceutical Sciences or Formulation Chemistry is a plus., • Background in small molecule drug development, including tech transfer, formulation development, and process development., • Experience in executing and supporting pilot batch manufacturing., • Ability to work effectively in a team environment and communicate technical information clearly., • Strong organizational skills and ability to meet project timelines., • Candidates with only pure R&D or Analytical R&D backgrounds will not be considered.