Scientist, Analytical Development
$42K-$82K (Glassdoor est.)
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 first half of 2020, which is evaluating RTX-134 for the treatment of phenylketonuria, an inherited metabolic disorder. Additionally, we have filed our first oncology IND for RTX-240 for the treatment of solid tumors. 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. 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
We are seeking an experienced and motivated Scientist for bioanalytical characterization to support RCT drug product development. This position will focus on developing analytical methods for characterizing cellular drug product and viral vector drug substance and identifying Quality Product Attributes, process-related and product-related impurities. The candidate will be responsible for experimental design, data analysis, technical reports and authoring CMC sections of the regulatory filings. The candidate will also represent Analytical development in the cross-functional CMC teams and drive analytical strategy and be accountable for project timelines. Expertise in developing and qualifying molecular and cellular biology assays is required. The ideal candidate will be a highly motivated individual who leads from the bench and enjoys having broad responsibilities and opportunities to work independently on various aspects of the cell therapy production platform.
Responsibilities
Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
Designs and executes experiments to characterize RCT drug product for protein expression, cell metabolism and lipid structure and function
Identifies critical product quality attributes in RCT drug product through forced degradation and structure-function related studies.
Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams
Contributes significantly and independently to project work which may include multiple projects within functional area.
Reviews, interprets and communicates data cross-functionally within CMC and/or project teams.
Serves as a technical mentor for junior staff and leverages technical expertise as a functional resource/trainer.
Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
Participate in the support of analytical activities at CMOs and CTOs related to analytics including method qualification, data trending, troubleshooting, optimization, review and reporting
Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team.
Responsible for integrating scientific/technical efforts around cross-functional issues
Qualifications & Education
PhD in biochemistry, cell and molecular biology or related pharmaceutical science; 0-2 years relevant industry experience
Extensive knowledge of hematopoietic stem cell biology and/or red blood cell physiology is strongly preferred
Experiences in developing and executing cellular characterization assays and demonstrated expertise in one of the following areas - flow cytometry, qPCR, multiplexing soluble protein platforms, RNA sequence and/or single cell characterization platforms or mass cytometry.
Understanding of viral transduction process and viral analytics is strongly preferred
Understanding and experience of analytical assay validation is a plus.
Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer of clinical processes to a CMO, or tech transfer of product release & characterization or clinical assays to a CRO, or other third party is a plus
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
4.4
Rubius Therapeutics
