Manufacturing Speciailist

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
September 11 2017
Organization Type
Biotech
Manufacturing Speciailist

Position Summary

Moderna is seeking a cGMP Manufacturing Specialist based at their Cambridge, MA site. This position will eventually transition to our new GMP Manufacturing site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials.  The Manufacturing Specialist uses expert knowledge of cGMP regulations and downstream biopharmaceutical production processes to manage investigations and improvement initiatives within manufacturing operations.

Responsibilities

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
  • Manages cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions
  • Conducts complex document revisions and/or document management including batch production records and manufacturing procedures
  • Performs training with staff on the floor, as needed
  • Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
  • Works independently with minimal supervision and direction
  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
  • Creates and presents trending and metrics reports
  • Monitors production processes
  • Participates in equipment start-up, commissioning, and validation activities
  • Ensures equipment operational readiness
  • Assists with troubleshooting in case of equipment failure
  • Participates in defining robust process parameters during routine manufacturing campaigns
  • Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns

Qualifications

  • High school diploma/GED or Biotech Certification with 7-10 years of experience, or Bachelor's Degree with 5+ years of experience in biopharmaceutical operations
  • Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment
  • A comprehensive understanding of regulatory requirements and their applications in a cGMP environment
  • Minimum of 2 years' experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment
  • Excellent written and oral English language skills
  • Bachelor's degree in Engineering or Life Sciences is preferred
  • Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
  • Ability to manage multiple competing priorities in a fast-paced environment
  • Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements
  • Background in lean manufacturing methodologies and operational excellence
  • Experience interacting with representatives of regulatory agencies
  • Project management experience

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Moderna 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. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.