PharmiWeb.jobs: Global Life Science Jobs · 4 days ago

Senior Scientist/Principal Scientist, Drug Product Development

New Brunswick, NJ

Full-time

Hybrid

Senior Level

4+ years exp

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Responsibilities

Collaborate across BMS sites with Drug Product, Analytical, API, Quality, and Regulatory functions.

Develop oral formulations for clinical studies and commercialization.

Support drug product formulation and process development including enhancing oral bioavailability, stability, and processability.

Prepare CMC regulatory documents.

Maintain safety, regulatory, and compliance standards in pharmaceutical development.

Collaborate with cross-functional team members for technology transfer and scale-up activities.

Develop, coach, and mentor others.

Prepare technical reports, batch records, SOPs, publications, and oral presentations.

Qualification

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Formulation DevelopmentPharmaceutical ProcessingDrug Product DevelopmentHands-On ExperienceDrug SubstanceExcipientsPharmaceutical Unit OperationsQuality AttributesStatisticsRisk AssessmentCGMP PrinciplesRegulatory RequirementsCMC DossierExperimental DesignProblem-Solving Interpersonal SkillsLeadershipCommunication

Required

Completed BS and minimum of 7 years; MS and minimum of 4 years; or Ph.D. and minimum of 2 years in Pharmaceutical Science, Chemical Engineering, or related discipline with pharmaceutical development experience.

Experienced in formulation development, pharmaceutical processing related to drug product development and hands-on experience.

Depending upon the level, fundamental to strong understanding of drug substance, excipients, pharmaceutical unit operations (blending, milling, sieving, granulation, tableting, encapsulation, coating, spray drying), intermediate and critical quality attributes, statistics, risk assessment approaches, and cGMP principles.

Basic knowledge of regulatory requirements for the CMC dossier for regulatory submissions within the development section as an author/reviewer.

Demonstrated problem-solving and troubleshooting skills.

Strong capabilities in experimental design and execution.

Ability to work independently.

Ability to provide leadership, guidance, and training to others within the department.

Strong verbal and written communication skills.

Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration, and accountability are valued.