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. Their role will include the startup of the Norwood, MA facility by assessing/procuring equipment, developing SOPs, batch records and training material.
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
· Participates in cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions
· Conducts document revisions and/or document management including batch production records and manufacturing procedures
· Performs training with staff on the floor, as needed
· Participates 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:
· High school diploma/GED or Biotech Certification with 6+ years of experience, or Bachelor's Degree with 3+ years of experience in biopharmaceutical operations
· Expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment
· An understanding of regulatory requirements and their applications in a cGMP environment
· 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 understanding of 21 CFR part 11 requirements preferred
· 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:
· Daily on-site catered lunches.
· Company-provided iPhone.
· Free parking, monthly subway pass or a subsidized commuter rail pass.
· 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.
· 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.
· Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Our Mission: Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.