Senior Scientist I, Analytical Development

Senior Scientist I, Analytical Development

Cambridge, MA

Requisition Number:

What will you do?

Devise and execute the analytical development strategies and deliverables for small molecule drug substances (DS) and drug products (DP) of projects in development from pre-clinical through post approval lifecycle management.  Duties include:

• Assess and address analytical needs in the development of drug substances (DS) and drug products (DP), from pre-clinical to commercial product launch;
• Solve complex technical issues and provide technical direction to drug development experiments performed both internally and at external laboratories;
• Independently 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 for clinical trial material in collaboration with key stakeholders;
• Development and justification of product release and stability specification
• Author, review, and/or approve SOPs, analytical protocols and technical reports;
• Author, manage, and/or review pertinent analytical sections of regulatory submissions;
• Present to cross functional teams and effectively communicate analytical issues and solutions to project teams and senior leadership;
• Develop chromatographic methods (GC and LC) for small molecules, including drug substance and drug product;
• Understand and utilize ICH Guidelines and compendial requirements;
• Generation of technical documents and technical presentations;
• Troubleshoot technical problems for development and manufacturing;
• Write and review analytical procedures and SOPs as needed;
• Review peer's work;
• Collaborate in the design and execution of formulation and process development experiments;
• Mentor and train junior staff on various analytical techniques.

What minimum qualifications do we require?

Master’s degree in Pharmaceutics, Analytical Chemistry, or a closely related field (or foreign equivalent degree), plus 8 years of experience in small molecule drug substance and drug product analytical pharmaceutical development.  (In the alternative, will accept Ph.D. and 5 years as described).  Experience, which may be gained concurrently, must include:

• 5 years of hands-on experience providing advanced skills in technologies for pharmaceutical analysis (HPLC and UPLC with UV/Vis, QDa, RID, and CAD detectors; MS, FTIR, GC-HS, UV/Vis, KF, Dissolution with fiber optics UV detection, PSD, SEM, TOC) for development and validation of analytical methods for new drug substances and drug products.
• 5 years of experience authoring and executing method validation protocols and reports, for APIs, IPCs, raw materials, non-APIs and cleanout samples, establishing specifications for new drug substances and drug products and authoring analytical regulatory sections, applying knowledge of regulatory requirements and guidelines (cGMP, ICH, FDA, and USP) consistent to the stage of pharmaceutical development.  
• 5 years of hands-on experience in analytical software packages (Empower, openlab chemstation, Malvern, TIAMO, ASAP Prime, Fusion QbD, ELN, and Cirrus GPC.)
• 5 years of experience working cross-functionally with formulation, process development, chemical development, QA, QC, and Regulatory groups and providing analytical expertise to progress drug substance and drug product development.

* This position is part of Blueprint Medicines’ employee referral program and is eligible for an employee referral incentive bonus.

What additional qualifications will make you a stronger candidate?

• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

COVID-19 Vaccination Requirement

As a biotechnology organization, it is our responsibility to do everything we can to safeguard the health and safety of our workforce, our communities, and the patients we serve.  That is why, prior to their start date, new hires must provide confirmation that they are fully vaccinated against COVID-19, or be approved by Blueprint for an exemption for health reasons contraindicating the vaccines or sincerely held religious beliefs.  Accommodation requests for either of these reasons should be made to TotalRewards@blueprintmedicines.com.

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA-Policy-Statement, the EEO Poster and its Supplement, as well as our Pay Transparency Statement. 

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood 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 systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.