Process Development Document Specialist (Contractor)

Our Opportunity......

We’re looking for a motivated, detail-oriented, and efficient Process Development Document Specialist, with a background in process characterization or quality documentation to join our team for a 6 month contract engagement. You’ll work closely with the Process Development team to support completion of multiple development and characterization reports and other documents, helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors.

In this role, you’ll perform data verification, assist with formatting documents, maintain an always current status tracker, and work closely with Document Control to drive documents through the review and approval process to meet project timelines.

As a member of our Technical Operations team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field-leading advisors, best-in-class partners, and an experienced team.

This is a hybrid role; including time on site in our Bedford, MA office as needed.

You Will....

Core responsibilities

• Support completion of process characterization reports and other process development documents working closely with authors.
• Perform Data Verification to ensure accuracy in reports.
• Assist with formatting of documents.
• Work with the manager and Process Development team to establish a document tracker. Keep tracker up-to-date with status of each document and communicate with all authors and PD management.
• Work closely with Document Control, including submission of Document Change Request forms as needed

You Bring...

Core Qualifications

• BS or BA in a life sciences field
• 4+ years of relevant experience in biotech/pharma, preferably Process Development (PD), Analytical Development (AD), Quality Control (QC), Quality Assurance (QA).
• Working knowledge of cell biology and/or engineering.
• Proven ability to work with high attention to detail
• Excellent planning, coordination, and time management skills 
• Working proficiency with Microsoft Word and Excel, and willingness to learn and use other system.
• Excellent oral and written communication skills. You listen to understand and communicate effectively and persuasively with partners and colleagues. 
• Ability to build and maintain productive relationships with colleagues within functional team and across the organization.
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.  
• Flexible - adapts to change in a fast paced, rapidly developing environment
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency

Bonus Qualifications:

• Prior experience with Benchling or other ELN
• Prior experience or working knowledge of quality/GMP/ALCOA documentation principles
• Prior experience with process characterization
• Prior experience in cell therapy setting