Principal Scientist/Associate Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Principal Scientist/Associate Director, Quality Control and Analytical Technologies Company: Colorado School of Mines Alumni

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Colorado School of Mines Alumni Job Center PrincipalScientist/Associate Director, Quality Control and AnalyticalTechnologies

RT Principal Scientist/Associate Director, Quality Control andAnalytical Technologies Rubius Therapeutics is a clinical-stagebiopharmaceutical company developing a new class of medicinescalled Red Cell Therapeutics™. Our proprietary RED PLATFORM® wasdesigned to genetically engineer and culture Red Cell Therapeutics™that are selective, potent and off-the-shelf allogeneic cellulartherapies for the potential treatment of several diseases acrossmultiple therapeutic areas. Our therapies can potentially be usedto kill tumors in cancer and to regulate the immune system for thetreatment of autoimmune diseases. Our IND for RTX-240, our firstoncology candidate for the treatment of solid tumors, has beencleared by the FDA. Additionally, we plan to file an IND forRTX-321 for the treatment of HPV-positive tumors by year-end.

We are proud of our passionate, high-performance culture – onebased on a set of values that are the cornerstone of who we are andhow we hold ourselves accountable. Founded in 2013, we are based inCambridge, MA and currently expanding across all functions withinthe organization. Red blood cells are no longer just for carryingoxygen. Check us out atwww.rubiustx.com , or follow us on Twitterand LinkedIn or like us on Facebook.

Summary As a key member of the newly formed Quality Control andAnalytical Technologies team, the Principal Scientist/AssociateDirector will oversee the lifecycle of analytical and bioanalyticalmethods in support of early and late-phase clinical developmentwith future commercial approval in mind. The responsibilitiesinclude but are not limited to method optimization, transfer,qualification, and validation; authoring and reviewing CMC sectionsof IND, IMPD, BLA, and MAA. The position requires a strongknowledge of cGMP/ICH/FDA/EMA regulations and regionalpharmacopeia.

This position will operate in a highly matrixed environment fromRubius’s Smithfield, RI manufacturing facility or Cambridge, MA.Strong partnerships with Cambridge Analytical Development and bothCambridge and Smithfield Quality Units is critical. This strategicinterface between Technical Operations and Quality will beresponsible for managing QCAT laboratories in conjunction with theSmithfield 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 alittle dirty. If you’re interested in developing productunderstanding starting early in clinical development and buildingand leading a team capable of great achievements, this may be foryou. Diversity of thoughts, experiences, and backgrounds make usstronger, so the ability to listen, debate, and collaborate is amust. And last, but not least, we insist on having fun on thisjourney.

Responsibilities A leadership role expected to embrace Rubius’svalues; we are inventive, we have integrity, we are inclusive, wehave courage and we work with urgency

Lead activities for analytical/bioanalytical test methodsqualifications, validations and method transfer for startingmaterials and drug products in support of clinical development

Oversee analytical/bioanalytical method training program

Establish and manage QCAT laboratories

Manage data review, statistical analysis, troubleshooting, andcomplex problem solving

Collaborate with QA to generate, review and approvedocumentation, including SOPs, change controls, deviations, CAPAs,and OOS/OOT investigation reports

Partner with QA, QC, Process Development, AnalyticalDevelopment, MS&T and Program Management to influence productand regulatory strategy, due diligence

Author, review and approve Quality specific CMC sections forregulatory filings

Provide strong leadership in troubleshooting, and complexproblem solving and participate on cross-site product qualityinvestigations teams

Partner with Quality Control GMP testing lab effectively andefficiently

Manage project-related timelines (in-house and at contractlaboratories) to meet corporate goals

Requirements

A strategic thinker that can break down barriers, drive greatdecisions, and make an impact in a rapidly growing smallcompany

Experience with cell and/or gene therapy products, vectors,plasmids, and cell banks

Extensive hands-on method development experience in flowcytometry, ELISA, qPCR/ddPCR, and cell-based potency assay.

Experience in next-generation sequence is a plus

Use of scientific methodology to solve problems or to pursuescientific inquiry

Experience and ability to use DOE for assay optimization androbustness

Strong understanding of statistical analyses to drive setting ofspecifications and understanding of stability data

Experienced building teams, for both today and tomorrow, throughan 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 apath

Strong knowledge of global regulations and guidelines (EU, U.S.,Japan)

Bachelor of Science degree in a scientific discipline isrequired, Ph.D. is preferred

A minimum of 12 years of experience in bioanalytical methoddevelopment, qualification, and validation in the industry, ideallyall clinical phases through commercial drug product.

Ability to Travel (approximately 20%)

Job Information

Job ID: 54083671

Location:

Massachusetts, United States

Position Title: Principal Scientist/Associate Director, QualityControl and Analytical Technologies

Colorado School of Mines Golden, CO 80402

Keywords: Colorado School of Mines Alumni, Cambridge , Principal Scientist/Associate Director, Quality Control and Analytical Technologies, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Principal Scientist/Associate Director, Other , Cambridge, Massachusetts