BioSpace · 2 days ago

Senior Scientist/Principal Scientist, Drug Product Development

New Brunswick, NJ

Full-time

Hybrid

Senior Level

2+ years exp

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Comp. & Benefits

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Responsibilities

Key member of a dynamic scientifically driven team, dedicated to the design, development, and characterization of robust small molecule drug product formulations.

Develop oral formulations for clinical studies and commercialization.

Support (Senior) or Lead (Principal) drug product formulation and process development including evaluating the need and potential for enhancing oral bioavailability, stability, and processability of drug candidates through appropriate formulation strategies.

Support preparation of CMC regulatory documents.

Support departmental initiatives for assigned projects and methodologies.

Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.

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

Collaborate with cross-functional team members to develop and optimize formulations and enable technology transfer to CMOs and other sites for manufacturing and scale up activities.

Principal Scientist will develop, coach and mentor others.

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.