SUPPLIER QUALITY ENGINEER - DRUG

Position Title: Supplier Quality Engineer - Drug

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Operations Quality Manager

 

 

Summary

 

This position is a hybrid role based at our Newton, MA site, will report directly to the Manager, Operations Quality, and will be responsible for the quality management of the Contract Manufacturing Organization (CMO) and other critical suppliers supporting the development and manufacturing of Lumicell’s drug product. This position is responsible for the management & control of these suppliers in compliance with applicable standards of GMP and Lumicell procedures.

 

Additionally, this position will support internal quality operations and device supplier quality activities, as needed.

 

This role will partner closely with the VP of Pharmaceutical Development and CMC. Strong collaboration and communication skills will be required to effectively work in a startup environment.

 

Responsibilities:

  • Manage supplier qualification and process validation activities at Lumicell’s CMOs and critical suppliers related to drug product.
  • Ensure critical drug suppliers are prepared for FDA’s Pre-Approval Inspection (PAI).
  • QA Reviewer and approver of Master Batch Records.
  • Lead supplier audits on behalf of Lumicell (standards in scope include PIC/S and ICH Q7A).
  • Provides quality oversight for assessments of Supplier Change Notifications from suppliers related to drug product, including change impact assessments, and owning/driving change actions through implementation.
  • Collaborate with suppliers to drive resolutions to non-conformances identified with suppliers related to drug product.
  • Monitor performance of suppliers related to drug product and initiate corrective action as required.
  • Reviews and approves investigations/corrections performed by a supplier.
  • May assist in preparing for and hosting of regulatory inspections/audits.

 

Critical Competencies for Success:

  • Experience in the biotechnology and/or pharmaceutical industry.
  • Experience in CMO operations.
  • Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment.
  • Strong verbal and written skills.
  • Capable of working effectively under minimal supervision.
  • Flexible and able to respond quickly to shifting priorities.
  • Thorough understanding of quality systems, cGMPs/cGDPs
  • Fluent with electronic Quality Management Systems (eQMS); Arena preferred
  • Experience leading, training and/or implementing root cause analysis and effective investigation practices.
  • Certified Quality Auditor

 

Qualifications:

  • A minimum of 6 years with 2-4 years of directly relevant experience in a regulated environment
  • S./B.A. Degree (related field preferred)

 

COVID Policy:

  • Lumicell has an implemented and strictly enforced a COVID Policy that’s intended to keep all employees safe when working on-site.
  • Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.

 

 

Position Type/Expected Hours of Work

  • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
  • This is a Hybrid position, and the ability to be on-site as needed is required.

 

Travel

  • Travel should be expected for this position for approximately 25% of the time.

 

EEO Statement

  • Lumicell is an equal opportunity employer

 

Other Duties

  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

To apply for this position, please send your resume to careers@lumicell.com.