(Contract) Manufacturing Associate II
We are looking to fill a contract second shift position for a Manufacturing Associate II, Aseptic Processing in our new state-of-the-art cGMP Clinical Manufacturing facility in Norwood. This role will primarily be tasked with the aseptic processing of drug product in Grade A and B environments. The Drug Product Manufacturing group is responsible for aseptically filling drug product following detailed standard operating procedures and master batch records while following aseptic technique and first air principles. The group plays a critical role in the manufacturing of human medicinal drug product. The successful candidate will work directly in the manufacturing of drug product batches, collaborate with management in the investigation and resolution of deviations, and assist in the continuous improvement of aseptic processing.
Here's What You'll Do:
- Aseptic processing of Drug Product and filling of drug product vials daily following detailed standard operating procedures and master batch records working in Grade A and B environments.
- Writing and updating standard operating procedures and master batch records.
- Adherence to cGMPs and good documentation practices.
- Support/conduct GMP quality investigations into any deviations that occurred during the routine Aseptic processing of Drug Product and filling of drug product vials. Such investigations will require that the senior associate work with various subject matter experts across the organization to identify root cause and appropriate Corrective/Preventive Actions (i.e. CAPA).
- Ensure timely and effective CAPA implementation for any root cause investigations that identify contributing factors related to drug product operations.
- Carefully document all findings according to standard operating procedures.
- Ensure the controlled Grade A and B manufacturing area is clean and remains in a state of control.
- Ensures that drug product equipment is maintained in good working order including compliance to the calibration, preventive maintenance, and requalification requirements.
- Assist in the training of employees in the aseptic processing of Drug Product.
Here's What You'll Bring to the Table:
- BS/BA with 0-2 years of experience working in a cGMP environment .
- The successful candidate must have worked in Grade A and B controlled spaces performing aseptic processing under adherence to FDA and EU regulations.
- Experienced in aseptic technique and following first air principles.
- Experienced writing SOP's and/or Quality approved documentation.
- Willingness to work as a team to support other departments when needed.
- Solid communication skills.
- Ability to repeatedly follow detailed instructions and maintain focus on the task at hand.
- Package and label materials for storage and/or shipment.
- Good hand/finger dexterity.
- Good hand and eye coordination.
- Ability to sit for extended periods of time.
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.
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.