Senior QC Specialist, Stability - 2362
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.
Key Responsibilities & Accountabilities:
- Manages stability sample submissions to internal and external testing labs.
- Manages tracking of the stability sample pull schedule per approved protocols.
- Performs data review, interprets results, compares results to approved specifications, generates Certificate of Analyses (COAs) and enters data into database.
- Trends stability data for critical components, drug substance and drug product using statistical software. Experience with JMP is preferred.
- Routinely communicates stability trends and changes to expiration dating to CMC Teams.
- Prepares protocols and reports and initiates document workflows in eDMS. Experience with Veeva preferred.
- Prepares stability sections for IND, IMPD, BLA and MAA as requested.
- Collaborates with peers to execute well defined assignments.
- Identifies and communicates technical problems anddata discrepancies.
- Supports OOS, OOT, and Investigations and works with QA on associated deviations, CAPAs, and change controls. Assists with method transfer and method validations at vendors as appropriate.
Knowledge, Skills & Capabilities:
- Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
- A strong understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations.
- Previous experience in Quality Control and specifically Stability is required.
- Experience in a broad variety of analytial testing techniques, including HPLC, UV, CE, Bioassay, PCR, Gel Electropherisis, GC-MS, cell-based potency, and biological assays.
- Experience in statistical analysis of analytical data, including biological assays
- Proficiency in the use of Excel, PowerPoint, Veeva eDMS, and JMP statistcal software.
- Good verbal and written communication skills.
- Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives.
- Demonstrated organizational skills to managing multiple projects and priorities.
Education & Relevant Work Experience:
- BS Degree in Biology, Chemistry or other Life Sciences
- Minimum of 5 years of related experience
- Experience in Quality setting with particular interest in stability studies and data trending
Physical & Travel Requirements (if applicable):
- Minimal travel will be required.
- Onsite work at multiple facilities in Massachusetts (Cambridge and Waltham) will be necessary
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.
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