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Scientist/ Engineer

Posted 15 days ago

  • Expiry Date: 13 October 2022
  • Referral: 216155@accuick.com

Job Description:

  • The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations.

  • This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems.

  • The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

  • Working experience of deviation investigations utilizing root cause analysis tools.

  • Working experience in the CAPA process and ability to identify and verify effectiveness.

  • Technical writing skills and ability to collaborate effectively in cross functional teams.

  • Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.

  • Ability to support health authority inspections.

  • Knowledge of data trending and tracking, including use of statistical analysis software a plus.

  • Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.

  • Ability to set priorities, manage timelines and effectively react/manage changing priorities.

  • Ability to work with management (global and site) and support corporate and departmental goals.

  • Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.

  • Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).

  • Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.

  • Ability to train new team members on the investigation process

Education and Experience:

  • Requires a Bachelors Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).

  • Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.

  • Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).

  • An equivalent combination of education and experience may substitute.

DUTIES AND RESPONSIBILITIES:

  • Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.

  • Lead investigations and cross functional investigation teams, and close reports in a timely manner

  • Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.

  • Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.

  • Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.

  • May Initiate change control documentation.

  • Identify functional area SMEs to perform impact assessments as part of the change management process.

  • Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.

  • Provide technical support for manufacturing investigations / CAPAs / change controls as needed.

  • Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.

  • Handle complex issues and solve problems with minimal guidance.

  • Provide training to new investigations team members.

  • Serve as author or technical reviewer of departmental procedures as appropriate.

  • Support manufacturing and Quality Control testing of CAR T products as needed.

  • Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.

  • Continuously support S12, living the ?patients first mission and fostering a ?Right First Time mindset.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613