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.

Published Category: Manufacturing & Technical Operations