Cerevel Therapeutics is a growing mid-market CNS company with a brand new lab. Come join us & grow!

Employer
Cerevel Therapeutics
Location
Cambridge, Massachusetts
Salary
Ultra Competitive base/bonus, LTI, equity, 401k match, health benefits, unlimited vacation
Closing date
Jan 3, 2022

View more

Field of specialization
Biotechnical, Pharmaceutical
Work Function
Development-Product, Laboratory, Research-Applied
Job Type
Full time
You need to sign in or create an account to save a job.

Title: Senior Principal Scientist – Drug Product Formulation

Reports to: Director – Late-phase & Commercial CMC

Location: Boston, MA

Type: 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 Parkinson’s disease, schizophrenia, epilepsy, anxiety, major depressive disorder and substance use disorder.

Headquartered in the Cambridge, MA, 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 his/her own unique thinking and approach to Cerevel while sharing our core values and convictions

 

Role Summary

Cerevel is seeking a Senior Principal Scientist with significant experience in drug product formulations with an emphasis on late clinical-stage to commercial development to join our Late-phase and Commercial CMC group in Cambridge, MA. The Senior Principal Scientist will report to the Director of Late-phase and Commercial CMC, and they will provide technical leadership and expertise in drug product development and formulation activities of small molecules post-proof of concept through long-term commercial support. They will work with the pillars of pharmaceutical development to best leverage Cerevel’s internal formulation development capabilities including small scale wet-granulation, roller compaction, fluid-bed drying, blending, and pan-coating as well as a growing array of analytical and physical characterization instruments and equipment. Additionally, they will identify and manage external partners for late-phase development through long-term commercial manufacturing while driving pharmaceutical development of Cerevel’s portfolio of late-stage programs. The Sr. Principal Scientist is recognized as a subject matter expert both within and outside the department and will be a leader and a driver of pharmaceutical development as part of this growing, dynamic team.

 

Key Responsibilities

· Guide and drive formulation and process development activities for Cerevel late-stage to 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 (some travel necessary), reviewing of batch records, and process analytical 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 across a portfolio of projects

· 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 staff to assess and support drug product characterization and shelf-life setting

 

Required Qualifications

· Demonstrated expertise in late phase and commercial formulation development, formulation characterization, and optimization

· 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, nanoparticles, 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

 

Desired Traits

· Experience in crystal form characterization and control

· Desire to work in a fast-pace, dynamic environment with capability of leading a team

· Exposure to QBD principles

· Experience in authoring and reviewing drug product sections of late-phase INDs as well as NDAs

· A Team player capable of pushing for individual and team growth

· Knowledge of commercial product life-cycle management and process trend analysis

 

Education

 

· Ph.D. (or equivalent degree) in relevant discipline and 6+ years relevant work experience

· B.S. / M.S. in relevant discipline and 12+ years relevant work experience

Apply for Cerevel Therapeutics is a growing mid-market CNS company with a brand new lab. Come join us & grow!

Fields marked with an asterisk (*) are required

Your file must be a .doc, .pdf, .docx, or .rtf. No larger than 1MB
Selected file:
Your communication preferences

When you apply for a job we will send your application to the named employer, who may contact you. By applying for a job listed on C&ENjobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please contact us. All emails will contain a link in the footer to enable you to unsubscribe at any time.

You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert