- Manages, coaches, and develops the growing team of QC Analysts
- Performs multiple bioanalytical testing assays such as flow cytometry, ELISA, qPCR, cell count, and rapid USP safety assays (sterility, endotoxin, mycoplasma).
- Establish data systems and tools including LIMS, tracking, trending, and report out dashboards.
- Manages QC quality records including, but not limited to, Deviations, Investigations, CAPAs, Change Controls, and ensures that all related activities are completed in a timely manner.
- Authors, reviews and approves QC-related documentation (CoA, Methods, SOPs, reports, etc.) and provides documentation support to QA, as needed.
- Leads Out-Of-Specification investigations.
- Collaborates with Product Analytical Development team in the transfer of analytical assays to QC.
- Coordinates with Manufacturing for in-process and product release test sample submission and testing
- Attends functional meetings to discuss ongoing work
- BS/MS degree in a relevant scientific discipline required, at a minimum
- 10-12+ years of relevant biotech/pharma industry experience, including Quality Control experience supporting cGMP areas
- 3+ years' experience supervising/managing direct reports
- Demonstrated industry knowledge of cGMP
- Experience leading people and/or projects with history of achieving results and outstanding outcomes
- Strong data tracking, trending, and analysis skills.
- Strong communications skills; a team player who can lead, mentor, and inspire others
- Experience participating and/or supporting regulatory inspections preferred
- Gene or cell therapy product experience preferred
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Systems & Controls Engineer
4 days ago
TEC Group Inc. Chelsea, United States Full time / Contract: · This position requires developing knowledge of all Testing processes, programs, and applications at Stellantis. The person hired for this position must be able to trouble shoot, root cause and resolve any problems detected by our customers in their Test Labs. They must also h ...
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Control Systems Engineer
4 days ago
GE Renewable Energy Power and Aviation Lynn, United StatesJob Description Summary · The controls engineer is responsible for the design, test, project management and maintenance of engine control logic, application software, modeling and hardware interfaces in support of engineering and test activities to assure GE Aviation's TFTJ engin ...
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Control System Engineer
3 weeks ago
Premier Group Recruitment Boston, United StatesJob Description · Job DescriptionJOB – Control System Engineer · LOCATION – Boston, MA · TERM - Direct Hire / Permanent · RATE – $110,000 - $125,000 · My client – an innovative manufacturer of special purpose machinery is on the lookout for an experienced Control System Engineer ...
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Control Systems Engineer
3 weeks ago
SharkNinja Needham Heights, United StatesOur purpose is to positively impact people's lives every day in every home around the world We work very hard to provide our consumers with high-quality, exciting 5-star products that make life easier. We thrive on passion and innovation and are looking for great people, with gre ...
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Stellar Enterprises The Meadows, United StatesWe love Freiburg because... · it's wonderfully diverse. And so are we as an employer. That's why we're looking for applicants who are passionate about their field and want to help us and our city move forward. People of different backgrounds, genders, gender identities, ages, ski ...
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Control Systems Engineer
3 weeks ago
Johnson Controls International Lynnfield, MA, United StatesBuild your best future with the Johnson Controls team · As a global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. Our teams are uniquely positioned to support a multitude of in ...
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Control Systems Engineer
3 weeks ago
Econocorp Randolph, United StatesAs a control systems engineer, you will specialize in designing, implementing, and maintaining control systems in a market supplying 40.9 billion dollars of automated packaging machinery worldwide to consumer-packaged goods needing to package their products as they come off their ...
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Control System Engineer
2 days ago
NEXHR Bridgewater, United StatesPrincipal Responsibilities · Supports Project Execution in achieving positive outcomes in safety, reliability, efficiency, cost, and customer service. · Ensures compliance with all safety, health, environmental and quality standards and fosters a culture of safety during the ex ...
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Control Systems Technician
3 weeks ago
Electric Hydrogen Devens, United StatesElectric Hydrogen's mission is to make molecules to decarbonize our world Our outstanding people are our most important asset and will allow us to deliver hydrogen from renewable electrolysis for heavy industry, at prices below fossil fuels. · As a Control Systems Technician, you ...
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Control Systems Engineer
1 day ago
GE Aerospace Lynn, United StatesJob Description SummaryThe controls engineer is responsible for the design, test, project management and maintenance of engine control logic, application software, modeling and hardware interfaces in support of engineering and test activities to assure GE Aviation's TFTJ engines ...
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Control Systems Engineer
3 days ago
GE Aerospace Lynn, United StatesExecute, with guidance from senior engineering team members, the analysis, design, test, and integration activities required to deliver engine controls solutions for GE Aviation products. Activities include: Evaluate the functional requirements to ac Systems Engineer, Systems, En ...
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Control Systems Lead
2 days ago
Synerfac Stoughton, United StatesControl Systems Lead · Dayshift, Thursday-Sunday · The Control Systems Lead (CSL) is responsible for providing Subject Matter Expert support within the 24x7 fulfillment center operations. The primary focus is on maintaining, advanced troubleshooting and modifying material handl ...
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Control Systems Engineer
6 days ago
Axcelis Technologies Beverly, United StatesResponsibilities: Control system design, including requirements, schematics, firmware, and cable designs. · Design and program motion controllers (i.e. PMAC) and tune the robot into performance. · PLC and IO system design and programming (Beckhoff preferred) · Build test stand ...
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Control Systems Engineer
3 weeks ago
Jabil Clinton, United StatesAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast networ ...
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Control Systems Engineer II
6 days ago
Nuvera Fuel Cells Billerica, United StatesJob Title · Control Systems Engineer II · Job Family · Job Description · Join Nuvera Fuel Cells, LLC, a trailblazer in sustainable innovation manufacturing fuel cell engines for on- and off-road vehicles and equipment, port and maritime applications, and stationary and portab ...
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Senior Electrical/Control Systems Engineer
3 weeks ago
Ingman Company Boston, United StatesJob Description · Job DescriptionOur client is an engineering consulting firm focused on transit and rail projects across the US. This company has seen annual growth of almost 25% per year. · Requirements: · - 10+ years of experience in the electrical distribution design of 13.2 ...
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Senior Controls Systems Engineer
2 weeks ago
Incendia Partners Peabody, United StatesSenior Controls System Engineer · Greater Boston area · (US Citizen or Green card holders only/ relocation assistance may be available for highly skilled candidates) · Salary to 170K · The Senior Controls System Engineer is a leader in the fields of mechanical vibration isola ...
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Power System Controls Specialist
3 weeks ago
TDX Swedesboro, United StatesJob Description · Job DescriptionSalary: · TDX Global Solutions (TDXGS) is located in Swedesboro, NJ, just outside of Philadelphia, PA. Leveraging over 100 years of on staff combined experience, we design power generation, power distribution (switchgear), and balance of plant co ...
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Combat Control Systems Technician
1 week ago
Dobbs Defense Solutions, LLC Groton, United StatesJob Description · Job DescriptionOur Mission · At Dobbs Defense, we deliver mission-centric IT, Cyber, and data analytics solutions for our government and commercial clients through the convergence of automation, innovation, training, and education. Delivering high-quality IT, cy ...
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Combat Control Systems Technician
3 weeks ago
Dobbs Defense Solutions, LLC Groton, United StatesJob Description · Job DescriptionOur Mission · At Dobbs Defense, we deliver mission-centric IT, Cyber, and data analytics solutions for our government and commercial clients through the convergence of automation, innovation, training, and education. Delivering high-quality IT, cy ...
Manager, Quality Control Systems - Waltham, United States - TScan Therapeutics
Description
Position Summary:TScan Therapeutics is a clinical stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Control (QC) professional to join our team as Manager QC Systems, supporting our internal GMP cell therapy manufacturing.
The Manager is a hands-on manager that can organize and lead a team of QC personnel, support and execute QC testing, and contribute significantly to overall Quality Control strategy The ideal candidate will have experience working in a GMP QC laboratory setting, experience with cell and gene therapy test methodologies, compendial safety testing and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan's discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.
Manager, Quality Control Systems professionals in Waltham
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Doug Huston
Talented Project Mangager/Engineer