Posted in Other 30+ days ago.
The Role:
Moderna is seeking a second shift Supervisor of Manufacturing, to lead a cohesive team responsible for manufacturing cGMP mRNA medications for evaluation in human clinical trials. 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 hands-on front-line leader, accountable for leading a second shift team in support of an automated, fast paced and short turnaround operation to deliver a mRNA medicines to the clinic. 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. They will play a key role in the COVID-19 production ramp up in the Norwood, MA facility by supporting commissioning activities while leading day to day manufacturing operations. They will hire and develop a high-performing, flexible manufacturing team capable of meeting a fast manufacturing operation timeline.
Here's What You'll Do:
Safely produce mRNA medicines
Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time to the clinic
Oversee the hiring, training, development, retention and performance of staff for the leadership and execution of manufacturing operations.
Develop batch records, SOPs and training materials for ramp up for COVID-19 production at the Norwood Facility
Closely partner with QA peers for rapid disposition of Moderna medicines
Develop comprehensive operating plans and monitors achievement of business and financial goals.
Development of effective working relationships with both internal and external partners.
Here's What You'll Bring to the Table:
Requires BS in a relevant science or engineering discipline plus 5 years' experience in a biotechnology manufacturing/quality/development environment; or an MS with 2-5 years' experience; or 10+ years professional experience with 5 years' being in a biotechnology manufacturing/quality/development environment.
Previous management or project experience is required
Subject Matter Expert on the set up/use/process of TFF Systems, Chromatography systems, single use process materials/consumables is preferred.
Thorough knowledge and understanding of cGMPs and FDA guidelines is 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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