Vacancy caducado!
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.Editas is seeking an experienced Microbiologist to lead the Sterility Assurance Program at Editas’ cGMP manufacturing facilities. This is an important position that will refine and lead all aspects of the microbiological control strategy in support of early and late-phase clinical development with future commercial approval in mind. This includes collaborating with internal and external strategic partners to author, review and approve EMPQ, APV, raw material and Drug Product safety testing, and oversight of all aspects of the Environmental Monitoring Program. You will be an active member of the Manufacturing Quality Operations Team, working to define sterility assurance strategy and objectives. We’re looking for someone that understands “phase appropriate”, isn’t afraid to take risk, and will roll-up their sleeves and get a little dirty. If you’re interested in building and leading a team capable of great achievements, this may be for you. Diversity of thoughts, experiences and backgrounds make us stronger, so ability to listen, debate and collaborate is a must. And last, but not least, we insist on having fun on this journey.Key Responsibilities & Accountabilities:
Expected to embrace Editas’ s core values of Engagement, Teamwork, Drive, Resilience, and Accountability.
Work closely with internal and external partners to initiate and investigate EM excursions following notification.
Perform data analysis, root cause analysis, and closure of EM investigations.
Coordinate with QC sample management team to submit samples (e.g., EM, APV, DP) to testing labs.
Collaborate with contract manufacturing organizations to obtain and review quarterly and annual reports for EM trending.
Perform microbiological testing (Sterility, Endotoxin, Mycoplasma, etc.) independently following established methodology, procedures, and SOPs.
Analyze organisms from environmental monitoring and utility samples.
Maintain accurate sampling and testing records and adhere to cGMP expectations.
Report, initiate and close OOT/OOS and deviations.
Perform independent troubleshooting of analytical microbiological methods.
Author or review all data, SOP, test methods, validations, and other applicable documents, such as protocols and reports, related with microbiological and chemical analytical methods and other quality records.
Method validations related to microbiological testing.
Participate in compliance related teams working towards the goal of continuous improvement of microbiological test methods.
Assists QC Management with budget and resourcing.
Partners with Quality Compliance for inspection and audit readiness activities in coordination with Corporate Quality.
Supports Quality Risk Management through identification, communication and mitigation of program risks.
Partners with peers in manufacturing, engineering, validation, logistics, Corporate QA, and Corporate QC to ensure adherence the QMS and effective issue resolution.
Perform other laboratory duties as assigned.
Perform maintenance of applicable instrument/ equipment calibration, temperature monitoring, reagent preparation, material and supply ordering and other general lab related responsibilities, as needed.
RequirementsKnowledge, Skills & Capabilities:
Working experience of environmental monitoring is preferred.
Experience with biologics is required, experience with cell and/or gene therapy products is preferred.
Expert knowledge in microbiological methodologies and technologies.
Collaborative with partners to advance the Editas mission.
Strong knowledge of global regulations and guidelines (EU, U.S., Japan).
Previous experience with clinical and commercial manufacturing, specifically BLA/MAA filings and subsequent inspections and commercial launch requirements.
Experience working in a fast-paced and matrixed environment.
Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
Education & Relevant Work Experience:
A minimum of a bachelor’s degree in microbiology or related discipline is required.
A minimum of 8 years of working experience in Biotech or pharmaceutical QC microbiological laboratory.
Physical & Travel Requirements:
On-site at the Waltham and the Devens Manufacturing facilities
Ability to effectively work with remote and hybrid teams.
Ability to routinely travel ( 25%) to CMO facilities in North Carolina and Colorado
BenefitsBenefits Summary: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.
Vacancy caducado!