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The company:
With deep expertise in chemistry, nuvalent is creating selective medicines to address the needs of patients with cancerNuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The role:
The scientist / senior scientist, analytical sciences will be a contributing member of the cmc team, acting as a technical subject matter expert (sme) for analytical development and quality control from development candidate nomination through development and commercialization of various development programsThe successful candidate needs to demonstrate a proven track record of working in a virtual environment with cros/cmos to deliver analytical methods, characterization data, and stability studies in support of developing and delivering drug substance (ds) and drug product (dp) for fast-paced clinical development programsUsing strategic thinking, strong technical analytical experience, and an effective knowledge of industry regulatory guidance, the candidate will support ds and dp development efforts, drive specification strategy, define stability program, and contribute to the authoring and review of regulatory submission documentsIn addition, the candidate will take responsibility for the management of nuvalent`s reference standard management program.
Reporting to the head of analytical sciences within pharmaceutical development, the srScientist has responsibility for the analytical aspects of drug substance and drug product development and manufacturing activities across the relevant nuvalent cro and cdmoThe sr scientist, analytical sciences, will interface with the drug substance, drug product, quality assurance, and regulatory cmc functional representatives on those programs to which they contributeResponsibilities include ensuring that drug substance and drug product analytical support are timely, high quality, and consistent with the phase-appropriate strategy outlined by the project team and cmc team.
The successful candidate will drive value through the following areas/interactions:
Responsibilities:
Manage the cross-program reference standard management program (characterization, storage, distribution, and inventory management).
Help define and execute on analytical development and qc strategy for nuvalent development candidates
Responsibility for ds and dp method development, demonstration of scientific soundness, and phase-appropriate validation
Technical review of documents for analytical development, characterization, release, and stabilityQc review for completeness, accuracy, and consistency with specifications as applicable.
Design and execution of phase appropriate stability studies
Leadership of shelf-life extension strategy for various nuvalent products
Contribute to the analytical/qc technical aspects for all or portions of a program on a cmc team
Participate in the strategic definition and justification of phase-appropriate sm, intermediate, ds, and dp specifications.
Track and trend release and stability results as part of product and method life-cycle management
Participate as needed on investigation teams as the analytical/qc sme.
Author and review analytical-relevant regulatory submission documents
Author and review relevant change controls and sops.
Competencies include:
A strong understanding and knowledge of cgmp/ich regulations and usp guidelines and an ability to apply them to analytical ds and dp development and manufacturing is required.
Previous exposure to method development, registration stability design, and process/method validation
Excellent organization and multi-tasking skills
Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
Qualifications:
Bs or equivalent in chemistry or related discipline with 8-10 years of relevant industry experience
Phd in chemistry or related discipline with a minimum of 2-3 years of industry experience
Proven track record solving analytical and qc challenges
Mastery of current ich guidelines and related industry guidelines and practices
Technical leadership experience with cros and cdmos
Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections
Nuvalent provides equal employment opportunities (eeo) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
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