Manufacturing Supervisor, Drug Substance, Night

5 months ago

Oxford, United Kingdom Moderna Full time

We are excited to announce that we are expanding our team and have multiple positions available for this role - join us in shaping the future*

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna’s strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility, part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK. We’re looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all.

Moderna is seeking a Night Shift Manufacturing Supervisor, Drug Substance for our state-of-the-art mRNA vaccines production unit at our Manufacturing Site in the UK. This role is pivotal in managing production timelines, ensuring cGMP compliance, and overseeing health and safety regulations. You will be instrumental in the technical ramp-up of manufacturing processes and be required to demonstrate digital proficiency and operational leadership.

Within 3 Months, You Will

Enforce safety procedures and Moderna’s guidelines, ensuring compliance with local HSE requirements.

Start fostering a collaborative relationship with the Day Shift team.

Develop batch records, SOPs, and training materials for various phases of commercial programs.

Coordinate with the Quality Assurance team for the timely disposition of commercial batches.

Manage documentation processes and oversee training and development of staff.

Within 6 Months, You Will

Establish robust processes for Batch Disposition.

Manage team performance and development, including regular one-on-one sessions.

Collaborate with Supply Chain to maintain inventory and review process orders.

Respond to routine equipment, process, and digital issues, ensuring continuous operation.

**Within 12 Months, You Will**:
Lead projects aimed at continuous improvement, aligning operations with corporate goals and commercial demand.

Drive initiatives to maintain manufacturing excellence.

Ensure team performance monitoring and make necessary adjustments for improvement.

Lead in troubleshooting and optimizing manufacturing processes.

**Here’s What You’ll Bring to the Table**:
Typically, 5-7+ years of experience in a GMP manufacturing environment

A Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field preferred

Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP

Demonstrated commitment to Moderna's values of Bold, Collaborative, Curious, and Relentless, embodying these values in the workplace

Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required

Exceptional written, oral communication, and organizational skills required

Skills in project management, including planning, execution, monitoring, and closing projects.

Experience with chromatography and tangential flow filtration would be an asset

Experience in audit / inspection preparation, understanding Health authority and regulatory guidelines

Knowledge of environmental monitoring practices in a cleanroom or controlled manufacturing environment

Specific expertise in mRNA technology, vaccine production and equipment - beyond a general scientific understanding

Understanding/Detailed knowledge of regulatory requirements specific to mRNA drug products and vaccine production

Expertise in quality control measures and assurance processes specific to pharmaceutical manufacturing

Knowledge of validation processes for manufacturing equipment and processes

Ability to analyze production data and generate reports for management

Specific methodologies for continuous improvement, such as Lean, Six Sigma, or others.

Experience in leading Kaizen events or other process optimization initiatives

Experience in coordinating with supply chain for raw materials and inventory management.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs a

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