31 applicants

Company

Original Job Post

Intra-Cellular Therapies · 3 days ago

Senior Manager, Formulation Development

New Jersey, United States

Full-time

Hybrid

Senior Level

$90K/yr - $140K/yr

5+ years exp

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Responsibilities

Lead and support activities for commercial manufacturing at CMOs. This includes but not limited to review and approval of drug product batch records, tech transfer, process optimization, and supervision of other manufacturing activities at CMOs.

Work within the CMC group and with internal and external project teams for timely execution of project plans.

Work collaboratively with CMOs on product-related quality or technical issues.

Lead, coordinate, and review activities related to OOS, deviations, change control, and CAPAs.

Manage documentation for process validation and commercial manufacturing under cGMP guidelines and review regulatory filings.

Collect, analyze, and summarize data for continuous process verification (CPV) and develop remediation plans for identified gaps.

Review and approve regulatory documents (INDs, IMPDs, and NDA/MAAs).

Create and review technical documents, reports, updates and presentations for cross-functional teams and management.

Maintain open lines of communication among CMC team members to ensure a high level of efficiency and knowledge transfer.

Perform other tasks as requested by ITCI senior management, complete all company and job-related training as assigned within the required timelines.

Qualification

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Pharmaceutical Industry ExperienceDrug Product DevelopmentTechnology TransferManufacturing ProcessesProcess TroubleshootingQuality SystemsRegulatory Compliance cGMPsRegulatory Compliance FDA/EURegulatory Compliance ICHChange ControlCAPAContract Manufacturing ManagementBatch Record ReviewLong-Acting Injectable Program FormulationFill-Finish FormulationSmall Molecule ExperienceExternal Third Parties EngagementTravel as NeededProblem-SolvingAttention to Detail Project ManagementCross-Functional Team LeadershipStatistical AnalysisControl ChartsTrending Data

Required

Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or closely related field. Masters or PhD preferred.

Minimum 5 years of experience in pharmaceutical industry either in a research and development, process development, manufacturing, or contract manufacturing role

Solid background in drug product and process development, technology transfer of manufacturing processes, troubleshooting and process improvements.

Significant experience working with and managing drug product contract manufacturers.

Attention to detail and familiarity with batch record review process and FDA quality standards.

Hands on experience with quality systems in a regulated environment, including change control, CAPA and investigations.

Working knowledge and experience with cGMPs, FDA/EU, and ICH guidelines.

Strong project management experience with cross-functional team leadership.

Experience engaging with external third parties (CMOs)

Some travel as needed, 5-10%

Must be able to perform all essential functions of the position, with or without reasonable accommodation