Full-Time

Senior Manager – Commercial Readiness Lead

Quality Operations

Posted on 5/6/2024

ElevateBio

ElevateBio

201-500 employees

Cell and gene therapy manufacturing platform

Industrial & Manufacturing

Senior

Waltham, MA, USA

Requirements
  • Minimum Bachelor’s Degree in Engineering, Science, or related field.
  • At least 8 years of experience in a Manufacturing, Technical Operations, Quality or GMP environment supporting complex products. At least 5 years in a Quality Assurance role. At least 3 years managing individuals or project teams.
  • Experience in autologous/allogeneic cell therapies or gene therapies is a plus.
  • Direct experience working in a commercial manufacturing facility strongly preferred.
  • Experience and/or familiarity with regulatory guidelines (ex. FDA CFR, EU EudraLex/Annex) is a plus
  • Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.
Responsibilities
  • Lead, facilitate, collaborate and track Quality workstream deliverables for Commercial Readiness project
  • Author and review updates to Standard Operating Procedures, Policies, Risk Assessments, and other documentation in accordance with project schedule and plan.
  • Direct ownership of Quality Operations owned documentation and support/review of other functional documentation that is part of the project.
  • Develop implementation plans and remediation plans as part of the implementation of new policies, procedures and programs. Support remediation of any gaps.
  • Partner with CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets to ensure appropriate quality processes and procedures are implemented for commercial cell-therapy GMP manufacturing, at-scale and in-compliance.
  • Ensure timely disposition of starting material, intermediates, drug substance and drug product.
  • Serve as Quality point-of-contact for client programs.
  • Provide on-the-floor QA oversight and support in the cleanroom suites to ensure compliance to cGMP regulations throughout the manufacturing process.
  • Ensure all product-related deviations are initiated, investigated and resolved in a timely, compliant, and scientifically sound manner.
  • Ensure that associated CAPAs are initiated and resolved.
  • Perform review of Quality records including Batch Records, Test Records, GMP protocols/reports, lab investigations, work orders, and change controls.
  • Identify compliance risks and escalate the issues to appropriate levels or management for timely resolution.
  • Develop and coach team members for fostering a Quality Culture and enabling performance.

ElevateBio stands out as a compelling workplace due to its specialized focus on cell and gene therapies, a cutting-edge area of medical science. The company's integrated platforms for gene editing and various forms of cellular engineering, alongside their purpose-built manufacturing platform, BaseCamp, highlight their commitment to process innovation and adherence to cGMP manufacturing standards. This not only positions ElevateBio at the forefront of biotechnological advancements but also offers its employees a dynamic and technically enriching environment to develop their careers.

Company Stage

Series D

Total Funding

$1.2B

Headquarters

Waltham, Massachusetts

Founded

2017

Growth & Insights
Headcount

6 month growth

1%

1 year growth

6%

2 year growth

32%