Manager, Analytical Development

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.

We are currently searching for a Manager, Analytical Development who will be responsible for managing Analytical Development activities at clinical manufacturing organizations (CMOs).

Job Responsibilities:

• Participate in developing, implementing, and executing the control strategy and plan for assigned projects, including:
  • Oversight of analytical method development, validation, and transfer for pharmaceutical dosage forms and APIs (active pharmaceutical ingredients) at CMOs.
  • Technical review and approval of analytical methods, method validation protocols/reports, method transfer protocols/reports, and stability protocols/reports for pharmaceutical dosage forms and APIs.
  • Technical review and approval of specifications, specification changes, and certificates of analysis for pharmaceutical dosage forms and APIs.
  • Technical review of release and stability data.
  • Regulatory assessment of stability protocols/studies (compliance with ICH Q1A-C) analytical method validation protocols/reports (compliance with ICH Q2) and specifications (compliance with ICH Q3A-D, Q6).
  • Technical evaluation of deviations and oversight of investigations related to analytical results (out of specification, out of trend, unexpected results).
  • Oversight of analytical method development, validation, and transfer for pharmaceutical dosage forms and APIs (active pharmaceutical ingredients) at CMOs.
  • Technical review and approval of analytical methods, method validation protocols/reports, method transfer protocols/reports, and stability protocols/reports for pharmaceutical dosage forms and APIs.
  • Technical review and approval of specifications, specification changes, and certificates of analysis for pharmaceutical dosage forms and APIs.
  • Technical review of release and stability data.
  • Regulatory assessment of stability protocols/studies (compliance with ICH Q1A-C) analytical method validation protocols/reports (compliance with ICH Q2) and specifications (compliance with ICH Q3A-D, Q6).
  • Technical evaluation of deviations and oversight of investigations related to analytical results (out of specification, out of trend, unexpected results).
• 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. 

Job Requirements:

• Graduate Degree in Chemistry or related discipline preferred
• 5+ years’ experience in Biotech/Pharmaceutical industry and Analytical Development
• Knowledge of FDA/EU CMC and ICH Quality guidelines
• Capability of collaboratively engaging with external 3rd parties (CMOs, CROs).
• Expert knowledge of Analytical Development pertaining to pharmaceutical dosage forms and APIs (active pharmaceutical ingredients), in particular chromatographic procedures and methods used to evaluate drug product performance and manufacturing process development
• Knowledge of other areas of pharmaceutical development such as API process development / manufacturing, formulation development / manufacturing and compliance requirements (current GMP and ICH Guidelines) desired
• Experienced in different phases of drug development
• Flexible in the face of shifting needs and/or priorities
• Able to interface well with peers and other department heads
• Familiar with computerized systems and compliance requirements
• Ability to produce high quality results across multiple projects and prioritize demands
• 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.

Manager, Analytical Development: Base Salary range $90K - $140K 

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