-
Manager, Quality Assurance Operations
1 week ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Manager, Quality Assurance Operations
3 weeks ago
Elevatebio Waltham, United States Full time· ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medic ...
-
Manager, Quality Assurance Operations
1 week ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Manager, Quality Assurance Operations
1 week ago
ElevateBio Watertown, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Editas Medicine Waltham, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
Editas Medicine Waltham, United StatesJob Description · Job DescriptionAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harne ...
-
Editas Medicine Watertown, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
Manager, QA Operations
1 week ago
TScan Therapeutics Waltham, United States**Position Summary**: · TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Mana ...
-
Assistant Director, Online Learning
1 week ago
Brandeis University Waltham, United StatesBrandeis University is delighted to announce a career opportunity as the Associate Director of Online Learning & Quality Assurance, Rabb School and Brandeis Online. At Brandeis, we offer a competitive benefits and compensation package which includes medical, dental and life insur ...
-
Biomanufacturing Associate Iii
15 hours ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Manager, Field Safety Ma Gas
1 week ago
National Grid Waltham, United States**About us**: · Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. Join us in our goal to delive ...
-
Operations Leadership Development Program
3 days ago
Thermo Fisher Scientific Waltham, United StatesWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your car ...
-
Supply Chain Manager
6 days ago
Nova Biomedical Waltham, United StatesNova Biomedical is hiring a **Supply Chain Manager** on-site in our **Waltham, MA **facility to oversee the day-to-day activities of the Purchasing department and coordinate the work of Supply Chain Specialists to ensure compliance with company policies, achieve best delivery tim ...
-
Data Platform Business Analyst
3 days ago
Commonwealth Financial Network Waltham, United StatesOverview: · Data Platform Business Analyst, Commonwealth Equity Services, LLC (dba Commonwealth Financial Network), Waltham, MA · Overview · Will aid in designing, developing, and delivering modern and efficient tools and business solutions. Will work with a team of Business Anal ...
-
Product Quality Lead
3 days ago
Alkermes, Inc. Waltham, United States***: · Provide QA Support for the Oral Dosage Manufacturing and Analytical activities at the Waltham site and any related CDMO activities performed externally. Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in ...
-
Business Auditor
3 days ago
National Grid Waltham, United States**About us**: · **National Grid is hiring a Business Auditor. This position will be located in Brooklyn, NY or Waltham, MA.** · Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the e ...
-
Technical Product Owner
4 days ago
Groe Advisors Waltham, United StatesYou'll tackle the challenge of juggling multiple priorities and mastering the technical complexities of the company's products. Your work will have a profound impact, driving customer-focused solutions, leading market innovations, and enhancing product quality. Your contributions ...
-
Editas Medicine Cambridge, United StatesJob Description · Job DescriptionAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harne ...
-
Front Desk Receptionist
1 week ago
Watertown Health Care Center Watertown, United States**Come Join Our Healthcare Family**: · **Watertown Health Care Center** is a skilled nursing home facility and takes pride in providing our residents with an amazing experience. We have an incredible tight-knit family of caregivers that serves our residents everyday with compassi ...
-
Assistant Manager
1 week ago
Midstate Arc Watertown, United States**Looking for an Assistant Manager to support program needs, clients and staff working in individuals homes.** · Are you looking for a meaningful career? Do you enjoy making a difference in the lives of others? · Midstate Arc is a non-profit organization supporting individuals wi ...
Quality Systems Supervisor, Site Quality Assurance Operations - Waltham, United States - Editas Medicine
Description
At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs.
This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we're committed to cultivating a culture where every individual feels valued and included.
To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.Together, we are leading the way towards a healthier and more equitable future.
Description
Editas is seeking a cooperative, highly motivated and experienced quality professional to support internal GMP manufacturing operations.
This position will be responsible for Quality Operations support of internal clinical manufacturing at the Editas Waltham and Devens GMP manufacturing facilities as a member of the Quality Operations team.
Specific responsibilities include but are not limited to Quality support/oversight and leading initiatives related to:
tech transfer and facility start-up, floor operations, QMS record review, MBR and SOP generation/revision, training, materials management, equipment management, and maintenance at the Editas Waltham and Editas Devens GMP manufacturing facilities.
Key Responsibilities:
Support Editas' clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team with primary focus on QMS records and technical reviews related to both Manufacturing and Quality Control.
Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
Author, review and/or approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing and QC testing).
Support QA on the floor activities including line clearance and QA process touchpoints as required.Establish, implement, maintain, improve, monitor and report on quality and compliance systems including management, review, or performance of associated trending.
Build and manage a small team of Quality Engineers/SpecialistsTrain and mentor other Quality staff
Support clinical lot disposition activities as needed.
Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
Independently review, manage, and/or perform complex investigations in cross-functional areas.
Exercise good judgment in issue identification, resolving moderate to complex quality issues, and escalations.
Act as QA liaison to site personnel to provide quality system expertise to help identify solutions and ensure compliance to cGMP
Plan and execute work independently with management consultation as needed.
Supports the organization in maintaining inspection readiness.
Provide QA oversight for product Shipments
Assist in internal and external audits as required.
Required Qualifications
B.S., M.S., with 6-8 years of experience or PhD in a scientific discipline with 1+ years of experience as a Quality professional in the biopharmaceutical industry
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Experience supporting cGMP biologics manufacturing required.A working knowledge of cGMP requirements in clinical or commercial biologics required.
Expertise performing/assessing root cause analysis investigations required.
Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products required.
Preferred Qualifications
Experience leading and managing a team.
Experience with both early and late phase clinical manufacturing preferred.
Experience with new product introductions or facility start-ups preferred.
Experience providing quality oversight for QC strongly preferred.
Excellent verbal and written communication skills including technical writing.
Experience in both clinical and commercial or late stage clinical preferred.
Experience with mammalian cells and/or gene therapies preferred.
Expertise performing/reviewing laboratory investigations strongly preferred.
Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making
Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized.
Ability to manage multiple projects with minimal oversight in and evolving environmentPhysical & Travel Requirements:
Ability to gown into a cleanroom
Ability to support a morning or evening shift schedule.
Some travel may be necessary
Benefits 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.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply.
Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.#J-18808-Ljbffr
