Job Information
Intra-Cellular Therapies, Inc Senior Manager, Formulation Development in New York, New York
Benefits Offered
401K, Dental, Life, Medical, Vision
Employment Type
Full-Time
“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”
Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.
As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, the Senior Manager, Formulation Development will be responsible for leading drug product development, technology transfer and manufacturing technical support activities at contract manufacturing organizations (CMOs). An additional component of the role is supporting ongoing commercial supply activities at the existing commercial sites as well as additional supply-chain expansion efforts. This role also leads investigations into manufacturing related deviations, implementation of CAPAs, change management, and process monitoring, as well as lifecycle management of commercial and development products. This position will require working both independently and in a team environment within the Manufacturing and Supply Chain group of the ITCI CMC team.
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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Requirements:
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)
Long-acting injectable program formulation and/or fill-finish formulation work desired.
Experience in statistical analysis, interpretation, and summarizing (control charts) of trending data preferred.
Small molecule experience is ideal.
Some travel as needed, 5-10%
Must be able to perform all essential functions of the position, with or without reasonable accommodation
Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.
Senior Manager, Formulation Development: Base Salary Range $90,000 - $140,000
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