Associate Director/Director, Analytical Development

Colorado School of Mines Alumni Job Center

• Associate Director/Director, Analytical Development

RT

Associate Director/Director, Analytical Development

Rubius Therapeutics Massachusetts, United States

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

The Associate Director/Director of Analytical Development will be responsible for strategic planning and execution of all analytical development activities supporting all clinical programs. You will lead early and late-stage analytical development, method qualification and transfer activities necessary for product release, characterization, and patient correlative assays as well as lead analytical comparability exercises during technical transfers and process improvements ensuring successful regulatory filings across multiple competent authorities. This is a great opportunity to develop and mentor a high-performing team of scientists with a vision of setting industry-leading scientific standards in a growing function that will require hands-on work to instruct and build the necessary skills within the group while leading day-to-day group activities including timeline and budget management and objective setting and execution. You will collaborate closely with Discovery, Process & Product Development, Quality Assurance, Regulatory Affairs, and Quality Control to optimize methods, set specifications, investigate out-of-specifications, and provide necessary assessments for change control in the GMP environment. We are interested in candidates with a proven track-record of technical excellence and product development and are looking for an authentic leader with a dedicated focus on developing organizations and growing future leaders. The successful candidate will integrate activities and perspectives across functions to deliver therapies that transform the lives of patients. 

Responsibilities

• Apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development
• Lead a team of scientist in multiple laboratories to develop a comprehensive analytical understanding of products pre-clinical and clinical development
• Assure appropriate laboratory controls for sample management, data integrity, reagent and equipment
• Author, review and approve IND, IMPD, BLA, and MAA sections; participate in scientific advice preparations and meetings
• Work with internal and external (CMO and CRO) laboratories to assure robust method development, transfer, and execution in GMP and GLP settings
• Lead technical review of analytical data and methods/stability/protocols/reports generated by internal and external laboratories to support early-stage clinical programs
• Extensive experience in analytical method development and qualification of relevant methods
• Author method development and qualification reports and test methods. Evaluate the suitability of new methods and oversee method qualification and validation
• Serve as a primary contact person for cross-departmental needs or projects and is accountable for key deliverables

Requirements

• A Ph.D. in a relevant, scientific field, coupled with 10- 12+ years relevant industry experience
• Understanding of techniques for single-cell analysis, cell phenotyping methods, and experience in cell or gene therapy
• Advanced hands-on experience with various analytical techniques including ELISA, qPCR, FACS and scientific knowledge in the characterization and transfer of pharmaceutical products.
• An in-depth understanding of Regulatory Guidelines in technical oversight of outsourced analytical work would be an added advantage.
• Experience preparing technical documents for internal distribution or inclusion in regulatory filings
• Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional area project teams
• Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Must be self-motivated, able to work in a fast-paced, deadline-driven environment and to deal with changing priorities
• Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals

Job Information

• Job ID: 51337564
• Location:
  Massachusetts, United States
• Position Title: Associate Director/Director, Analytical Development
• Company Name: Rubius Therapeutics
• Job Function: Biotherapeutics
• Job Type: Full-Time

Jobs You May Like

F

Sr Scientist, Cancer Biology

FogPharma

Cambridge, MA, United States

F

Principal Scientist, Protein Biochemistry (De…

FogPharma

Cambridge, MA, United States

SU

Seaspan ULC

Victoria, BC, Canada

D

Manager, Global Logistics and Distribution

Colorado School of MinesGolden, CO 80402

from Berkeley Job Site https://ift.tt/2UYfw1V
via IFTTT