Job Title: Scientist II, Analytical Development (Cambridge, MA)
Job Duties: Define experimental plans, analytical development strategies, and deliverables for our small molecule drug substances (DS) and drug products (DP) to ensure appropriate clinical control strategies are in place.
Duties include:
- Define experimental plans and analytical development strategies for test methods and specifications for small molecule programs.
- Prepare samples and analyze using complex techniques such as high performance liquid chromatography (HPLC), UV/Vis spectroscopy, Gas Chromatography (GC), Ion Chromatography (IC), dissolution, Karl-Fischer (KF), and Infrared (FTIR) Spectroscopy, etc.
- Design and manage the method development, validation, and transfer activities either internally or through the management of external CMO partners.
- Execute method development activities using HPLC (High performance liquid chromatography) and GC (gas chromatography).
- Author, review and approve method validation protocols and reports.
- Compile and summarize the results from complex lab experiments into shorter summaries to share with stakeholders.
- Prepare presentations and reports to communicate research results to project teams and senior leadership.
Position Requirements: Master’s degree (or foreign equivalent) in Pharmaceutical Science, Chemistry, or closely related field with 5 years of relevant small molecule analytical development experience. In the alternative, will accept a Ph.D. degree (or foreign equivalent) in Pharmaceutical Science, Chemistry or closely relate field and 2 years of experience as described.
Experience, which may be gained concurrently, must include:
- 5 years performing small molecule drug substance and drug product characterization analysis using the following techniques: HPLC, GC, ion chromatography (IC), Karl Fischer titration (KF), and infrared spectroscopy (IR).
- 5 years of experience developing analytical methods, i.e. HPLC and GC methods, and authoring method development reports.
- 5 years of experience designing and managing methods validation/transfer activities, including authoring/reviewing method validation protocols and reports for analytical methods.
- 5 years of experience conducting dissolution testing.
- 3 years of developing dissolution methods for drug products.
- 3 years performing cGMP analytical testing via HPLC and UV/VIS.
- Capabilities to resolve and/or troubleshoot complex technical issues and to provide trainings and instructions to junior scientists.
- Demonstrated knowledge of regulatory requirements and guidelines (cGMP, ICH, FDA, and USP) and the ability to apply the relevant guidelines to the stage of pharmaceutical development.
Why Blueprint?
At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.
This is the place where the extraordinary becomes reality, and you could be part of it.
Patients are waiting. Are you ready to make the leap?
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 [email protected].
For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement.
Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.
* This position is part of Blueprint Medicines’ employee referral program and is eligible for an employee referral incentive bonus.
524636507v.1
#LI-DNI
Top Skills
What We Do
Blueprint Medicines is a global precision therapy company that invents life-changing medicines. Applying an approach that is both precise and agile, we create therapies that selectively target the root cause of disease, 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 have brought our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for mast cell disorders, including systemic mastocytosis and chronic urticaria, breast cancer and other solid tumors.
With patients at the center of our mission, we aim to make real the promise of precision medicine to improve and extend life for as many people as possible. We know that in order to make a difference in their lives, we must create an environment where our employees — also known as the Blue Crew — can do their best work. Our culture of transparency, curiosity, and diversity pushes us to lead with integrity, act courageously, and draw upon a wide range of backgrounds and perspectives to make decisions. Ideas come from everywhere, from the C-suite to new hires, and each day we commit to approach one another with respect and trust.
We care deeply about making a profound impact where it matters most. Learn more about who we are and explore our career opportunities at https://www.blueprintmedicines.com/careers/.
Read our community guidelines: https://www.blueprintmedicines.com/community-guidelines
