Senior Business Analyst, Technical Operations

Rubius Therapeutics, Inc. Smithfield , RI 02917

Posted 9 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

We are seeking a Senior Business Analyst to support Technical Operations with 8+ years of Life Science/Biotech industry experience. They will be responsible for working collaboratively cross-functionally serving as the liaison between IT and Technical Operations to help design and optimize business processes, systems as Rubius builds out its manufacturing capabilities in Smithfield, RI. They will support process/system design and improvement projects and product launches through all phases of the project life cycle.

Responsibilities

  • Business Process, Systems, and Analytics - Analysis & Support Work with Technical Operations Department in support of strategic objectives; create/manage a long-term business application roadmap based on those objectives

  • Develop detailed documentation (gap analyses, process flowcharts, decision tables, etc.) to aid in the understanding of business requirements and potential solution options

  • Consult a broad group of stakeholders to understand all requirements; negotiate a process/system solution that will meet the needs of the broader group

  • Provide input into the usability and performance needs to assist technical teams in establishing the technical solution for the project

  • Document business requirements in the form of user stories and in other written documentation as required

  • Lead meetings to ensure business requirements are communicated to and understood by software developers

  • Change Management Summarize and communicate implementation solutions to business. Provide input and support to business during the implementation phase, including carrying out software user testing, composing SOPs, and/or conducting user training and implementation

  • Serve as frontline support in troubleshooting process and systems issues and provide ongoing operational support as required

  • Acts as project lead or project manager as required

  • Propose phasing strategies to efficiently implement projects

  • Works with minimal guidance from manager to deliver on medium and high complexity projects

  • Quickly develops a detailed understanding of the processes, systems, and analytics utilized by the business area

  • Consolidates input from business and technical stakeholders. Negotiates solutions to ensure a broad range of stakeholders' needs are met

  • Efficiently manages multiple projects with competing deadlines

  • Documents complex business processes

  • Delivers well-organized, informative presentations and requirements documents

Qualifications & Education

  • Bachelor's degree from accredited college or university is required.

  • 8+ years of industry subject matter expertise in life sciences manufacturing and supply chain business processes.

  • Strong business acumen of manufacturing and supply chain in a process industry to effectively analyze and identify business needs, understand impacts of business decisions, and quickly dimension business solutions.

  • Proven project management and leadership skills.

  • Knowledge of product costing in terms of new product development.

  • Knowledge of regulatory compliance.

  • Excellent team player, demonstrating strong interpersonal and collaborative skills Courageous, curious, and articulate.

  • Demonstrates outstanding written and verbal communication skills

  • Demonstrates effective analysis and communication skills

  • Ability to overcomes challenges to move projects forward

  • Experience with Computerized System Compliance using GAMP 5

  • Experience supporting LIMS and other lab systems
    #LI-PL1

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Quality Operations Specialist

Rubius Therapeutics, Inc.

Posted Yesterday

VIEW JOBS 12/11/2019 12:00:00 AM 2020-03-10T00:00 Rubius Therapeutics is a rapidly-growing, clinical-stage biopharmaceutical company that is genetically engineering red blood cells into an entirely new class of allogeneic, off-the-shelf cellular medicines. Our Red Cell Therapeutics™ (RCTs) 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. Our first RCT™ product candidate is RTX-134 for the potential treatment of phenylketonuria, a rare metabolic disorder. We expect to report initial clinical data by the end of 2019 from our Phase 1 clinical trial. Additionally, we plan to file our first oncology Investigational New Drug (IND) application 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. At Rubius, we are transforming them into medicines. Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn. Summary We are looking for a Senior Quality Operations Specialist to join our Smithfield, RI Quality Organization to support our Quality Operations Team. The Senior Quality Operations Specialist is an important position that supports ongoing quality assurance responsibilities in support of the manufacture, testing, and release of product at the Rubius Rhode Island Manufacturing Facility. The incumbent is expected to support evaluating deviations, change controls and disposition of clinical drug product. The Senior Quality Operations Specialist is responsible for ensuring reviews of Manufacturing and Quality Control/Assurance records are certified for compliance to in-house specifications/standards and Good Manufacturing Practices for all Rubius products. In addition, he/she will work with the Quality Systems Team to identify key continuous improvement opportunities to ensure quality systems are aligned with Rubius business strategy, industry standards and global regulatory expectations. The Senior Quality Operations Specialist will participate in departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements. Responsibilities * Reviews manufacturing and support records to certify compliance with specifications and procedures. * Makes recommendation to Quality Assurance Management for the release of product based on Quality Assurance record review and approval. * Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues. * Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending * Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness * Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems * Representing Quality Assurance at various project and technical meetings, as needed * Working with all departments to ensure timely completion of Deviations, CAPA, Change Controls, Investigations, and Environmental Excursions * Inputting information from the Quality Systems into electronic databases and generating reports from these systems * Capturing and reporting metrics around Quality System and Batch Record review turnaround times and closure/approval times. * Providing on the floor support to Manufacturing * Reviewing Manufacturing batch records and completing required documentation for batch disposition * Document creation and review, including Standard Operating Procedures, protocols, and reports * Performing Internal Audits and Data Audits, as needed. * Providing training to site personnel and contractors on GMP and the Quality System procedures Qualifications & Education * Bachelor's degree in Life Sciences, or related field or with 5 to 8 years' experience in biopharmaceutical/pharmaceutical or related industry with at least 3 years direct quality experience * Excellent written and verbal communication and negotiating skills * Experience with a cell therapy product is preferred * Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment * Ability to monitor and report on assigned tasks, goals and objectives * Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors 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

Senior Business Analyst, Technical Operations

Rubius Therapeutics, Inc.