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Manager/Senior Manager, Quality Control and Analytical Technologies

Company: HCPro, Inc.
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Manager/Senior Manager, Quality Control and Analytical Technologies

RT Manager/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. Our IND for RTX-240, our first oncology candidate for the treatment of solid tumors, has been cleared by the FDA. Additionally, we plan to file an IND for RTX-321 for the treatment of HPV-positive tumors by year-end.

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. Red blood cells are no longer just for carrying oxygen. Check us out atwww.rubiustx.com , or follow us on Twitter and LinkedIn or like us on Facebook.

Summary As a key member of the Quality team, the Manager/Senior Manager, Quality Control and Analytical Technologies will lead analytical efforts in support of early and late-phase clinical development with future commercial approval in mind. The responsibilities include but are not limited to method transfers and validations, driving data-driven and risk-based specification and stability strategies, managing reference material and critical reagents, and authoring and reviewing CMC sections of regulatory filings. The position requires a strong knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia.

This position will operate in a highly matrixed environment and will require strong partnerships with Cambridge Analytical Development, Quality Control and external testing labs. This strategic interface between Technical Operations and Quality will be responsible for Quality guidance and oversight of analytical methods.

We’re looking for someone that understands “phase appropriate”, isn’t afraid to take risks, and will roll-up their sleeves and get a little dirty. Diversity of thoughts, experiences, and backgrounds make us stronger, so the ability to listen, debate, and collaborate is a must. And last, but not least, we insist on having fun on this journey.

Responsibilities Embrace Rubius’ values; we are inventive, we have integrity, we are inclusive, we have courage and we work with urgency

Lead activities for analytical method transfer, qualification, and validation for drug substance/drug products in support of clinical development

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

Manage data review, statistical analysis, troubleshooting, and complex problem solving

Establish and manage QC method trending system

Manage reference standard and critical reagents

Manage the Specification Review Board for drug substance/drug product and drive scientifically sound and phase appropriate specification setting activities

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 regulatory filings

Complex problem solving and participate on cross-site product quality investigations teams

Partner with Quality Control GMP testing lab effectively and efficiently

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

Requirements

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

Experience with flow cytometry, cell-based potency assays, ELISA, qPCR, rapid sterility, rapid endotoxin, and rapid mycoplasma

Collaborative with partners to advance the Rubius mission

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

Bachelor of Science degree in a scientific discipline is required

A minimum of 8 years of experience in the industry, ideally all clinical phases through commercial drug product

Ability to Travel (approximately 20%)

Job Information

Job ID: 54215452

Location:

Massachusetts, United States

Position Title: Manager/Senior Manager, Quality Control and Analytical Technologies

Company Name: Rubius Therapeutics

Job Function: Biotherapeutics

Job Type: Full-Time

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Keywords: HCPro, Inc., Cambridge , Manager/Senior Manager, Quality Control and Analytical Technologies, Other , Cambridge, Massachusetts

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