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Principal Scientist, Process Development
Knewin Boston, MA
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$120k-152k (estimate)
Full Time 6 Days Ago
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Knewin is Hiring a Principal Scientist, Process Development Near Boston, MA

Company OverviewCerevel 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, Parkinsons 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 peoples 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 SummaryCerevel Therapeutics is seeking a talented synthetic organic chemist for a role in Process Development as a Principal Scientist. The Principal Scientist will apply and grow their expertise in small molecule drug substance synthetic process development as they contribute to Cerevels pursuit of its rich small molecule pipeline spanning pre-clinical through commercial candidates. This is a tremendous opportunity to apply and grow your skills in process development activities from the discovery chemistry interface (form selection and toxicology batch production) to preparation for commercial launch activities. Aided by and leveraging Cerevels internal laboratory capabilities while managing external partners, the Principal Scientist will develop scalable, cost-efficient, environmentally-sound synthetic processes for Cerevels novel candidates. This is an opportunity to be a part of a well-funded, growing, and collaborative company with a shared goal of realizing Cerevels mission of delivering innovative therapies for CNS disorders like Parkinsons, Alzheimers, and epilepsy.Key Responsibilities Drive design and execution, both internally and through external partners, of multi-step organic syntheses of small molecule drug candidates as a member of cross-functional development teamsProvide input and guidance to the planning, execution, and oversight of the technology transfer and validation of processes with CMO partners, ensuring the quality, safety, and efficacy of the product throughout the processIndependently apply sound scientific principles and creative thinking to ensure the selection of innovative and robust synthetic routes, pharmaceutical forms, and compound properties for development and scale-up of drug substance manufactureLeverage literature review and ongoing awareness of state of the art in designing and executing new routesCollaborate with Cerevels Global Quality Assurance function on investigations or events and resolve them in a timely mannerContribute to the completion of reports necessary to support regulatory strategies and filings such as INDs, NDAs, IMPDs, and NDAsPresent technical data to cross functional teams and senior managementCollaborate with internal groups such as Analytical Development, Formulation Development, Supply Chain, Global Quality Assurance, and Regulatory CMC to advance Cerevels pre-clinical and clinical candidatesRequired Qualifications Significant experience in small molecule process development from early phase route scouting through process optimization and scale-up toward late-phase clinical developmentHands on crystallization experience and working knowledge on solid polymorphic screeningExposure to technology transfer and process developmentand working with external partners to achieve process development goals and manufacturingFamiliarity with the preparation of process, analytical, and characterization reports suitable to support regulatory filingsManagement of on-time API deliveries for toxicology studies, formulation development,andpreclinical and clinical studiesFamiliarity with potential genotoxic impurity assessmentsWorking knowledge of the core analytical techniquessuch as HPLC, GC, LCMS, and NMRSound understanding cGMPs, ICH guidelines, applicable regulatory guidanceMay require up to 10% travelDesired Qualifications Hands-on experience with 50 kg deliveries and registration batchesExperience in process chemistry development at a sponsor company for compounds in phase 1 and 2Desire to work in a fast-paced, dynamic environmentDesire and willingness to contribute to lab-based activitiesStrong, independent problem solving and trouble shooting skillsDemonstrated capability to collaborate with analytical chemists, formulators, toxicologist, and quality professionalsEducation PhD in Organic Chemistry with a minimum of 5 years relevant work experienceCerevel 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.#J-18808-Ljbffr

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Job Summary

JOB TYPE

Full Time

SALARY

$120k-152k (estimate)

POST DATE

04/28/2024

EXPIRATION DATE

05/15/2024

WEBSITE

knewin.com

HEADQUARTERS

FLORIANOPOLIS, SANTA CATARINA

SIZE

100 - 200

FOUNDED

2011

CEO

LUCAS NAZARIO DOS SANTOS

REVENUE

<$5M

INDUSTRY

IT Outsourcing & Consulting

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