Senior Scientist I, Analytical Development - 2406
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
This role in Process and Analytical Development is critical to Editas’ efforts to develop safe and effective medicines using CRISPR- based gene editing technologies. This individual will support the development of analytical methods and studies for protein, ribonucleoprotein, and cells. A successful candidate in this role will develop assays independently, perform troubleshooting, provide cross functional support to Quality Control and regulatory filings, and contribute to the understanding of the primary, secondary, and higher order structure of our gene editing components.
Key Responsibilities & Accountabilities:
- Provide subject matter expertise in mass spectrometry for various projects and drive method development, optimization and streamline analyses for protein, ribonucleoprotein, and cells.
- Work with a cross functional team to identify gaps, troubleshoot methods, and perform in-depth phase appropriate characterization to support BLA/MAA and other regulatory filings.
- Provide technical expertise for process characterization, process validation and various root cause analyses and deviations as applicable.
- Provide training and mentorship for other scientists.
- Maintain awareness of new technologies in the field and leverage the knowledge for improving internal capabilities as applicable to cell & gene therapy and genome editing.
- Other responsibilities as applicable.
Knowledge, Skills & Capabilities:
- Advanced mass spectrometry expertise in intact mass, peptide mapping, native MS, glycosylation characterization, impurity identification and quantitation (specifically using the Thermo Orbitrap series mass spectrometer and related software for proteomics, small molecule, and lipid analyses). Experience with additional types of mass spectrometry instrumentation and platforms (TOF, QTOF, QQQ and MALDI-TOF) is also preferable.
- Experience with higher order structure characterization by Analytical Ultra centrifugation (AUC), Circular Dichroism (CD), Fourier-transform infrared Spectroscopy (FTIR), Nuclear Magnetic Resonance (NMR) spectroscopy is preferred.
- Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for cGMP operations
- Deep understanding of product development life cycle and stage gates from research to clinical development to commercial operations
- Ability to work with others to troubleshoot complex technical and scientific problems while showing sufficient independence in execution and thought processes.
- Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines.
- Team focused, demonstrate high level of integrity, and have strong collaboration, communication, interpersonal and organizational skills.
- Ability to diversify technical skillsets in a fast-paced organization
Education & Relevant Work Experience:
- PhD in a scientific discipline and a minimum of 5-8 years or Masters with 12+ years of experience with a focus on mass spectrometry-based analyses of biologics and/or cell and gene therapy; may include post-doctoral experience with PhD experience.
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.