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Senior Research Associate II / Scientist I, Analytical Development

Company: Blueprint Medicines Corporation
Location: Cambridge
Posted on: June 11, 2021

Job Description:

Senior Research Associate II / Scientist I, Analytical Development

Cambridge, MA

Requisition Number: PSM21-004

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.

What will you do?

This position will contribute to the analytical development strategies and deliverables for small molecule drug substances (DS) and drug products (DP) of one or more projects in development from pre-clinical through post approval lifecycle management. This person will define experimental plans in collaboration with internal and external laboratories to ensure appropriate control strategies are in place. This individual will also be responsible for authoring, reviewing, and/or approving internal and external reports, including but not limited to method development, method validation, investigation, and justification of specification reports as well as the appropriate analytical regulatory sections.

What will be your responsibilities?

  • Address the analytical needs of drug substances (DS) and drug products (DP) in development from pre-clinical to product launch
  • Solve technical issues and provide technical direction to experiments performed both internally and at external laboratories
  • Design and manage the method development, validation, and transfer activities both internally and through the management of external CMO partners
  • Influence the development of phase appropriate control strategies in collaboration with key stakeholders
  • Prepare presentations and reports to communicate results to project teams and senior leadership as required
  • Author, review, and/or approve analytical protocols and technical reports
  • Author, manage, and/or review pertinent Analytical Development related sections of regulatory submissions

What qualifications do we require?

  • Ph.D. in analytical chemistry or related field with 1 year of relevant small molecule pharmaceutical development experience, or a BS/MS in chemistry with 5 years of relevant small molecule development experience
  • Demonstrated knowledge of analytical technologies
  • Demonstrated knowledge of regulatory requirements and guidelines (cGMP, ICH, FDA, and USP) and the ability to apply the guidelines consistent to the stage of pharmaceutical development

What capabilities do you bring?

  • Resourcefulness/Flexibility - The ability to adapt to working efficiently within a variety of situations; adapts to change and to changes in job demands
  • Communication and Partnership - Ability to optimally express ideas in written and oral context; collaboration, team-building skills and interpersonal skills; genuine desire to be on a team and contribute to organizational and team goals
  • Effective Planning - Demonstrated effective time management skills and execution
  • Perseverance - Pursues tasks with energy, drive and initiative; comfortable in an accountable environment where you can make an impact
  • Problem Solving - Ability to understand a situation or problem by breaking it down into smaller pieces using a detailed approach and to identify patterns and connections between situations that are not obviously related
  • Relationship Building - Builds productive working relationships across a diverse spectrum of people

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Who we are:

We don't think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us matters and that our success depends on our ability to work together in a diverse community. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

Keywords: Blueprint Medicines Corporation, Cambridge , Senior Research Associate II / Scientist I, Analytical Development, Other , Cambridge, Massachusetts

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