Director/Senior Director, Quality Control And Analytical Technologies

Rubius Therapeutics, Inc. Smithfield , RI 02917

Posted 5 months ago

Rubius Therapeutics is a clinical-stage biopharmaceutical company that is generating red blood cells and engineering them into an entirely new class of allogeneic, off-the-shelf cellular medicines. Our Red Cell Therapeutics can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases. We expect to begin enrolling patients in our first clinical trial during the second quarter of 2019, which is evaluating RTX-134 for the treatment of phenylketonuria, an inherited metabolic disorder. Additionally, we plan to file our first oncology IND for RTX-240 for the treatment of solid tumors by early 2020. In total, we plan to file four to five INDs during 2019 and 2020.

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 based in Cambridge, MA and currently expanding across all functions within the organization. Having completed our initial public offering in July 2018, (Nasdaq: RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn.

Summary

As a key member of the Quality team, the Sr. Director/Director, Quality Control and Analytical Technologies will lead a team of scientists to oversee the lifecycle of analytical and bioanalytical methods in support of early and late-phase clinical development with future commercial approval in mind. This includes method transfers and validations, authoring and reviewing CMC sections of IND, IMPD, BLA and MAA; driving data driven and risk-based specification and stability strategies; managing reference material and critical reagents; and, overseeing training on methods. The position requires a strong knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia.

This position will operate in a highly matrixed environment from Rubius's Smithfield, RI manufacturing facility. Strong partnerships with Cambridge Analytical Development and both Cambridge and Smithfield Quality Units is 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 building 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

  • A leadership role expected to embrace Rubius's values; we are inventive, we have integrity, we are inclusive, we have courage and we work with urgency

  • Lead activities for analytical/bioanalytical test methods qualifications, validations and method transfer for starting materials and drug products in support of clinical development

  • Oversee analytical/bioanalytical method training program

  • Manage execution of the method qualification/validation and method transfer protocols

  • 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 all regulatory filings

  • Establish stability program for ancillary materials, starting materials and drug products in support of clinical development

  • Provide strong leadership in troubleshooting, and complex problem solving and participate on cross site product quality investigations teams

  • Manage Reference Material (qualification and inventory) and critical reagents

  • Establish Specification Review Board and drive scientifically sound and phase appropriate specification setting activities

  • Partner with Quality Control GMP testing lab effectively and efficiently

  • Manage project related timelines (in-house and at contract laboratories) to meet corporate goals

Qualifications & Education

  • A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing small company

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

  • Expert knowledge in analytical/bioanalytical methodologies and technologies; flow cytometry, ELISA, qPCR, rapid sterility, rapid endotoxin, rapid mycoplasma

  • Expert knowledge in cell-based potency assays

  • 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 path

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

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

  • A minimum of 15 years of experience in the industry, ideally all clinical phases through commercial drug product

  • Ability to Travel (approximately 15%)

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 careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.


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VIEW JOBS 7/18/2019 12:00:00 AM 2019-10-16T00:00 Rubius Therapeutics is a clinical-stage biopharmaceutical company that is generating red blood cells and engineering them into an entirely new class of allogeneic, off-the-shelf cellular medicines. Our Red Cell Therapeutics™ can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases. We expect to begin enrolling patients in our first clinical trial during the second quarter of 2019, which is evaluating RTX-134 for the treatment of phenylketonuria, an inherited metabolic disorder. Additionally, we plan to file our first oncology IND for RTX-240 for the treatment of solid tumors by early 2020. In total, we plan to file four to five INDs during 2019 and 2020. 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 based in Cambridge, MA and currently expanding across all functions within the organization. Having completed our initial public offering in July 2018, (Nasdaq: RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn. Summary As a key member of the Quality team, the Sr. Director/Director, Quality Control and Analytical Technologies will lead a team of scientists to oversee the lifecycle of analytical and bioanalytical methods in support of early and late-phase clinical development with future commercial approval in mind. This includes method transfers and validations, authoring and reviewing CMC sections of IND, IMPD, BLA and MAA; driving data driven and risk-based specification and stability strategies; managing reference material and critical reagents; and, overseeing training on methods. The position requires a strong knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia. This position will operate in a highly matrixed environment from Rubius's Smithfield, RI manufacturing facility. Strong partnerships with Cambridge Analytical Development and both Cambridge and Smithfield Quality Units is 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 building 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 * A leadership role expected to embrace Rubius's values; we are inventive, we have integrity, we are inclusive, we have courage and we work with urgency * Lead activities for analytical/bioanalytical test methods qualifications, validations and method transfer for starting materials and drug products in support of clinical development * Oversee analytical/bioanalytical method training program * Manage execution of the method qualification/validation and method transfer protocols * 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 all regulatory filings * Establish stability program for ancillary materials, starting materials and drug products in support of clinical development * Provide strong leadership in troubleshooting, and complex problem solving and participate on cross site product quality investigations teams * Manage Reference Material (qualification and inventory) and critical reagents * Establish Specification Review Board and drive scientifically sound and phase appropriate specification setting activities * Partner with Quality Control GMP testing lab effectively and efficiently * Manage project related timelines (in-house and at contract laboratories) to meet corporate goals Qualifications & Education * A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing small company * Experience with cell and/or gene therapy products, vectors, plasmids and cell banks * Expert knowledge in analytical/bioanalytical methodologies and technologies; flow cytometry, ELISA, qPCR, rapid sterility, rapid endotoxin, rapid mycoplasma * Expert knowledge in cell-based potency assays * 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 path * Strong knowledge of global regulations and guidelines (EU, U.S., Japan) * Bachelor of Science degree in a scientific discipline is required, Ph.D. is preferred * A minimum of 15 years of experience in the industry, ideally all clinical phases through commercial drug product * Ability to Travel (approximately 15%) 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 careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes. Rubius Therapeutics, Inc. Smithfield RI

Director/Senior Director, Quality Control And Analytical Technologies

Rubius Therapeutics, Inc.