Senior/Manager, Quality Control and Analytical Technologies
Company: Rubius Therapeutics, Inc.
Location: Cambridge
Posted on: February 24, 2021
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Job Description:
Senior/Manager, Quality Control and Analytical Technologies
Rubius Therapeutics is a clinical-stage biopharmaceutical company
developing a new class of medicines called Red Cell
Therapeutics---. Our proprietary RED PLATFORM-- was designed to
genetically engineer and culture Red Cell Therapeutics--- that are
selective, potent and off-the-shelf allogeneic cellular therapies
for the potential treatment of several diseases across multiple
therapeutic areas. Our therapies can potentially be used to kill
tumors in cancer and to regulate the immune system for the
treatment of autoimmune diseases. We are currently enrolling
patients in a Phase 1/2 clinical trial of RTX-240 in patients with
relapsed/refractory or locally advanced solid tumors. In addition,
RTX-240 is being evaluated in a second Phase 1 arm of the clinical
trial for the treatment of patients with relapsed/refractory acute
myeloid leukemia, and our IND has been cleared by the U.S. FDA for
RTX-321 for the treatment of human papillomavirus 16-positive
cancers. We are proud of our passionate, high-performance culture -
one based on a set of values that are the cornerstone of who we are
and how we hold ourselves accountable. Founded in 2013, we are
headquartered in Cambridge, MA, and our manufacturing facility in
Smithfield, RI was named 2020 Top 5 Best Places to Work in Rhode
Island among medium-sized companies by Providence Business News. We
are currently expanding across all functions within the
organization. Red blood cells are no longer just for carrying
oxygen. Check us out at--www.rubiustx.com , or follow us on Twitter
and LinkedIn or like us on Facebook. Summary As a key member of the
growing Quality Control and Analytical Technologies team, position
will oversee the lifecycle of analytical methods and drive CMC
analytical strategies in support of early and late-phase clinical
development with future commercial approval in mind. The
responsibilities include but are not limited to method
optimization, troubleshooting, transfer, qualification, and
validation, driving phase appropriate specification and stability
programs, authoring, and reviewing CMC sections of IND, IMPD, BLA
and MAA. The position requires a strong knowledge of
cGMP/ICH/FDA/EMA regulations and regional pharmacopeia and
experience with vector analytics is required. This position will
operate in a highly matrixed environment from the Rubius
manufacturing facility in Smithfield, RI or the headquarters in
Cambridge, MA. Strong partnerships with the Cambridge Analytical
Development, contract manufacturing organizations, and other
Quality functions are critical. This strategic interface between
Technical Operations and Quality will be responsible for managing
QCAT laboratories in conjunction with the Smithfield GMP testing
lab management. 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 developing
product understanding starting early in clinical development and
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. Responsibilities
Keywords: Rubius Therapeutics, Inc., Cambridge , Senior/Manager, Quality Control and Analytical Technologies, Executive , Cambridge, Massachusetts
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