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Principal Scientist, Formulation Development

2 months ago

Remote, Oregon, United States Cerevel Therapeutics Full time

Company Overview

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder.

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives.

Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

Cerevel is seeking a Principal Scientist with significant experience in small molecules oral solid drug product development with an emphasis on late-stage clinical to commercial development to join our Late-Phase and Commercial CMC Technical Operations group in Cambridge, MA. The Principal Scientist will report to the Director of Late Phase & Commercial CMC, Technical Operations, and will provide subject matter expertise and technical leadership in small molecule formulation development to lead drug product advancement through late-stage development, validation, and commercialization. The successful candidate will lead and oversee formulation-drug product process development, tech transfer, and manufacturing with external development and manufacturing partners; in addition to leveraging Cerevel's internal formulation development capabilities as well as a growing array of analytical and physical characterization instruments. They will work closely with colleagues across Technical Operations, Global Product Quality, and Regulatory CMC as they drive the drug product development, validation, and commercial manufacture, and launch.

Key Responsibilities

  • Guide and drive formulation and process development activities for Cerevel's late-stage clinical and future commercial programs
  • Provide technical support and day-to day management of outsourced drug product development activities with CMO partners
  • Manage manufacturing activities including monitoring production campaigns, reviewing of batch records, and process batch data
  • Present technical data to cross functional teams and senior management as a technical driver for Cerevel's late-stage development programs
  • Design, support, and analyze tech transfer and validation activities
  • Design, execute, and analyze experiments leveraging Cerevel's internal capabilities (including small scale wet-granulation, roller compaction, fluid-bed drying, blending, and pan-coating, solid-state physical characterization) to guide formulation development and/or troubleshooting
  • Work in close collaboration with the project CMC teams and related functions, including process development, analytical development, supply chain, Quality, Regulatory, DMPK, safety, and clinical and non-clinical development
  • Author and review CMC sections for regulatory submissions
  • Support any quality investigations or events and resolve them in a timely manner
  • Mentor, train, and recruit late-phase and commercial CMC staff
  • Identify and advocate new and emerging technologies in formulation development and physical characterization analysis
  • Partner with Analytical Development to assess and support drug product characterization, specifications, and investigations
  • The position requires a hybrid work model with 3-4 days per week on-site presence and may require travel as needed to support manufacturing-related activities across the GMP manufacturing sites

Required Qualifications

  • Demonstrated expertise in late-stage oral tablet formulation development, scale-up, formulation characterization, and optimization for small molecules
  • Subject matter proficiency in the development of oral formulations with deep experience in one or more of the following formulation techniques: solubilization, spray drying, hot melt extrusion, dry granulation, wet granulation, tablet compression, tablet coating and/or encapsulation
  • Knowledge and the ability to interpret and draw conclusions from data from common analytical techniques such as dissolution testing, hardness testing, HPLC, XRPD, IR/Raman spectroscopy and particle size analysis techniques
  • Ability to troubleshoot formulation issues, determine causes and possible solutions
  • Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment
  • Experience with managing CDMOs during late clinical-stage pharmaceutical development
  • Strong organizational, project management, and communication skills
  • Desire to work in a fast-pace, dynamic environment with capability of pushing for individual and team growth

Desired Qualifications

  • Experience in solid state characterization techniques
  • Exposure to QBD principles, drug product control strategy finalization, validation, and commercialization
  • Experience in authoring and reviewing drug product sections of late-phase INDs as well as NDAs

Education

  • Ph.D. (or equivalent degree) in relevant discipline and 5+ years relevant work experience
  • B.S. / M.S. in relevant discipline and 10+ years relevant work experience

Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.