Manufacturing Specialist

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
June 01 2019
Ref
R1670
Discipline
Life Sciences, Biology
Organization Type
Biotech
Manufacturing Specialist

The Role:

Moderna is seeking a cGMP Manufacturing Specialist based at their Norwood, MA site. 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.

Here's What You'll Do:
  • 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


Here's What You'll Bring to the Table:
  • Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master's Degree with 0-2 years industry experience
  • 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
  • Aseptic process experience
  • Drug product fill finish knowledge
  • 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


Here's What We'll Bring to the Table:
  • On-site subsidized cafeteria
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-PL1

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

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