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Scientist/Engineer III, Formulation & Drug Product Development

Company: Rubius Therapeutics, Inc.
Location: Cambridge
Posted on: June 1, 2021

Job Description:

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

We are seeking an innovative and highly motivated Scientist/Engineer III to join our Formulation and Drug Product Development team to design and develop our next-generation cryopreserved Red Cell Therapies (RCTs). The focus of this position involves the development of formulations and cell therapy manufacturing process development. The incumbent will be also be expected to partner with scientists in cell process development and analytical development to enable CMC activities supporting regulatory filings. They must have a deep scientific background in cell therapy and/or aseptic fill finish process development, who are comfortable working in a fast-paced entrepreneurial environment. The candidate must be independent, goal oriented, technically competent and able to efficiently work across multiple projects.

Responsibilities

* Work cross functionally within Technical Operations to develop solutions for scale-up of cell therapy fill finish process development. * Design and execute formulation, stability, and material compatibility studies to support regulatory filings. * Understand project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional, and external stakeholders * Serve as a technical mentor for junior staff. * Independently perform data analysis on complex data sets and/or assignments. Prepares summary reports and proper electronic notebook record keeping. * Collaborate with stakeholders in Manufacturing and Quality to implement new fill finish unit operations. * Evaluate new technologies to support cell therapy drug product manufacturing. * Serve as a lead on CMC and tech transfer teams. * This is a hands-on position requiring the execution of laboratory experiments.

Qualifications & Education

* PhD and 0-2 years relevant industry experience in biochemistry, biomedical engineering, or related pharmaceutical science; Or BS/MS and 7+ years relevant industry experience. * Prior experience with formulation development, container closure selection, and drug product material compatability * Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer for clinical manufacturing * Understanding and experience with analytical methods such as flow cytometry, ELISA, and fluorescence microscopy * Experience working in Biohazard Level 2 laboratories * Adept at managing multiple programs through cross functional collaboration * The ideal candidate is a fast learner with strong scientific curiosity, good interpersonal skills, and attention to detail

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.

Keywords: Rubius Therapeutics, Inc., Cambridge , Scientist/Engineer III, Formulation & Drug Product Development, Other , Cambridge, Massachusetts

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