Lead Specialist, QA Validation

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role

ElevateBio is looking for a Lead Specialist, Quality Assurance Validation (QAV), who will be responsible for managing cGMP compliance from a Quality Assurance perspective on technology transfer process, Engineering manufacturing runs, raw material introduction, method qualification/validation and transfer, and process validation. In addition, this position will support all process and technology transfer risk assessments, technical reports, change controls, discrepancies, deviations and CAPAs related to process validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.

Here’s What You’ll Do

• Act as QA Lead on cross functional Technology Transfer teams, liaison with clients
• Support optimization and development of internal infrastructure for QAV Technology Transfer processes
• Provide QA oversight of Technology Transfer Plans, engineering run protocols, reports, and discrepancies.
• Provide QA oversight in the development, review, and execution of technical protocols, reports, risk assessments, and discrepancy management.
• Provide QA oversight in development and review of new product master batch records, bill of materials, and sampling plans.
• Change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state; emphasis on New Product Introduction change controls.
• Review and assist in investigating deviations and discrepancies related to technology transfer activities and process validation testing.

Requirements

• Bachelor’s degree and at least 5 years of related experience; or Master’s degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.
  • Prior experience in Cell and Gene Therapy Manufacturing
  • Strong knowledge in technology transfer, process validation, process characterization
• Prior experience with CMC a plus
• Prior experience in client facing role a plus
• Strong knowledge of 21 CFR, ICH, EU regulations
• Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint)
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.

Physical and Environment Requirements:

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to lift 15-20 lbs
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $50/hour - $69/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.