Senior/Manager, Quality Control and Analytical Technologies
Company: Rubius Therapeutics, Inc.
Posted on: February 24, 2021
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
- Lead activities for analytical methods qualification,
validation and transfer for starting materials and drug
- Oversee analytical method training program.
- Drive phase appropriate specification and stability programs,
including development of specification acceptance criteria for
product release and stability.
- Manage data review, statistical analysis, troubleshooting, and
complex problem solving.
- Collaborate with QA to generate, review and approve
documentation, including: SOPs, change controls, deviations, CAPAs
and OOS/OOT investigation reports.
- Partner with QA, QC, Process Development, Analytical
Development, MS&T and Program Management to influence product
and regulatory strategy, due diligence.
- Author, review and approve Quality specific CMC sections for
- Provide strong leadership in troubleshooting, and complex
problem solving and participate on cross site product quality
- Partner with Quality Control GMP testing lab effectively and
- Manage project related timelines (in-house and at contract
laboratories) to meet corporate goals. Qualifications & Education
- Bachelor of Science degree in a scientific discipline is
required, advanced degree is preferred.
- A minimum of 8 years of industry experience in method
development, qualification, and validation, ideally all clinical
phases through commercial drug product.
- A strategic thinker that can break down barriers, drive great
decisions, and make an impact in a rapidly growing small
- Experience with cell and/or gene therapy products, vectors,
plasmids and cell banks.
- Extensive method development experience in titer, flow
cytometry, ELISA, qPCR, and potency.
- Experience and ability to use DOE for assay optimization and
- Strong understanding of statistical analyses to drive setting
of specifications and understanding of stability data.
- Experienced building teams, for both today and tomorrow,
through an investment in coaching and development.
- Inspiring and credible communicator.
- Collaborative with partners to advance the Rubius mission.
- A resilient and visionary Quality Leader willing to pave a
- Strong knowledge of global regulations and guidelines (EU,
- Ability to travel (approximately 20%). EEO Statement: Rubius
Therapeutics is proud to be an equal opportunity workplace and is
an affirmative action employer. We are committed to equal
employment opportunity regardless of race, color, ancestry,
religion, sex, national origin, sexual orientation, age,
citizenship, marital status, disability, gender identity or Veteran
status. If you have a disability or special need that requires
accommodation, please let us know. Recruitment & staffing
agencies:--Rubius Therapeutics does not accept agency resumes
unless contacted directly by internal Rubius Talent Acquisition.
Please do not forward resumes to our email@example.com account,
Rubius employees or any other company location; Rubius Therapeutics
is not responsible for any fees related to unsolicited
Keywords: Rubius Therapeutics, Inc., Cambridge , Senior/Manager, Quality Control and Analytical Technologies, Executive , Cambridge, Massachusetts
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