Scientist/Engineer - Manufacturing Investigator

3 days ago

Akron, Ohio, United States MassGenics Full time
Job Title: Scientist/Engineer

At MassGenics, we are seeking a highly skilled Scientist/Engineer to join our team as a Manufacturing Investigator. This role will be responsible for leading manufacturing and quality control investigations in support of CAR T operations.

Key Responsibilities:
  • Conduct thorough investigations of manufacturing and quality control issues using root cause analysis tools.
  • Lead cross-functional investigation teams and close reports in a timely manner.
  • Perform GEMBA walks with stakeholders to understand process steps and evaluate root cause analysis.
  • Work with functional teams to propose effective corrective and preventive actions (CAPAs) and develop CAPA plans.
  • Assess potential impact and risk associated with changes and develop mitigation strategies.
  • Provide technical support for manufacturing investigations, CAPAs, and change controls as needed.
  • Support deviation investigation defense during audits and site inspections.
  • Handle complex issues and solve problems with minimal guidance.
  • Provide training to new investigation team members.
Requirements:
  • 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 Bachelor's 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.

At MassGenics, we offer a competitive salary and benefits package, including medical and pharmacy coverage, dental/vision insurance, 401(k), health savings account (HSA), flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves (as required by law), employee assistance program (EAP).

We are an equal opportunity employer and prohibit any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where we operate.

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