Posted in Other 30+ days ago.
The Role:
Moderna is seeking a cGMP Manufacturing Associate for mRNA Manufacturing. This position is located at our new GMP Manufacturing site in Norwood, MA. The shifts in Large Scale Manufacturing at Moderna are: 1st shift from 6:00 am to 4:00 pm, 2nd shift from 2:00 pm to 12:00 pm and 3rd shift from 10:00 pm to 8:00 am. All shifts are on a 4x10 schedule with a weekend day requirement and are either Sunday through Wednesday or Wednesday through Saturday.
The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bioprocessing equipment and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts.
Here's What You'll Do:
Execute manufacturing operations using disposable technologies, automation, and Manufacturing Execution Systems (MES) to produce mRNA
Closely partner with QA peers for rapid disposition of mRNA
Demonstrate general knowledge of standard manufacturing practices and equipment.
Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Monitor process operations to ensure compliance with specifications.
Assist in the investigation of procedural deviations.
Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
Utilize knowledge to improve operational efficiency.
Adhere to gowning procedures and maintain a clean general operating area.
Adhere to documented waste handling procedures to respect environmental regulations.
Here's What You'll Bring to the Table:
Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field with 0-2 years, Associates with 2-4 years related experience or 5+ years of related GMP experience
Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
Exceptional written, oral communication, and organizational skills required
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. |
ModernaTX, Inc. |