MSAT Scientist II - 249708

This role supports Manufacturing Science & Technology (MS&T) activities for pharmaceutical products across development and commercialization, with a focus on parenteral and nasal dosage forms. The position contributes to scale-up, process optimization, technical documentation, and cross-functional collaboration while ensuring compliance with regulatory, quality, and safety requirements. The ideal candidate is technically strong, detail-oriented, and comfortable supporting projects in a fast-paced, regulated manufacturing environment.

Responsibilities:

• Execute Manufacturing Science & Technology (MS&T) activities with minimal supervision for pharmaceutical products, including parenteral and nasal dosage forms, supporting new products from scale-up through commercialization and ongoing post-commercialization process improvements.
• Develop a growing understanding of generic and novel drug development processes, regulatory agency requirements, and CMC strategies.
• Adhere to all company safety, environmental, quality, and compliance practices in accordance with departmental guidelines, SOPs, and applicable federal, state, and local regulations; ensure departmental SOPs are established and consistently followed.
• Support project execution under supervision by tracking action items, meeting timelines, and providing accurate technical information to cross-functional support teams.
• Build and maintain effective working relationships with cross-functional partners, external customers, and stakeholders; may serve as a scientific contributor on client calls related to MS&T activities.
• Prepare project protocols and define deliverables with limited supervision; review and evaluate technical data, documentation, and proposals.
• Provide technical support and guidance for both development-stage and commercial products through technical communications, reports, and memoranda.
• Learn to trend and analyze process data to ensure specifications are met, including performing Process Capability Analysis.
• Ensure batch records are clear, accurate, and operationally executable; support training of Operations personnel to ensure confidence in commercial manufacturing processes.
• Support assigned regulatory inspections and audits.
• Work effectively in a collaborative, team-oriented environment.
• Comply with all company policies and maintain flexibility in work schedule based on business needs.
• Perform additional duties as assigned.

Qualifications:

• Bachelor’s degree in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering, or a related discipline, with 3–5 years of relevant experience in MS&T or Product Development; or
• Master’s degree in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering, or a related discipline, with 1–3 years of relevant experience in MS&T or Product Development.
• PhD in Pharmaceutical Sciences or Formulation Chemistry is a plus.