Posted in Other 30+ days ago.
The Role:
Reporting to the Senior Manager, Manufacturing Specialists, this individual will be part of a cohesive team responsible for producing high quality mRNA-based medicines for commercial production and evaluation in human clinical trials. The Manufacturing Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support day to day operational support through deviation and CAPA writing with a focus on but not limited to Commercial Lipid Nanoparticle Manufacturing.
Here's What You'll Do:
Practice and promote safe work habits and adheres to safety procedures and guidelines
Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events
Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)
Conduct document revisions and/or document management including batch production records and manufacturing procedures
Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues
Follow-up on requests, issues, and projects and report statuses to manager/ working teams
May perform metric trending
May generate technical protocols and reports
May support internal and external audits
Work independently with minimal supervision and direction
Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
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; Degree in Engineering or Life Sciences is preferred
Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment
A comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe
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
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:
About Moderna:
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
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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ModernaTX, Inc. |
ModernaTX, Inc. |