Sr. Specialist, Quality Assurance
Moderna is seeking a senior Quality Assurance Specialist for mRNA Manufacturing of Personalized Cancer Vaccines. This position will be based in our new GMP Manufacturing site in Norwood, MA.This position will be Sunday-Wednesday or Wednesday-Saturday, first shift.
The individual in this role will be part of a cohesive team responsible for rapidly releasing GMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight of early stage clinical products and/or depth of knowledge in drug product filling. He/she will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
Here's What You'll Do:
- Participate in quality focused teams across Moderna's broad ecosystem of functions.
- Authors and reviews SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
- Oversee and review executed electronic batch record documentation.
- Develop batch records, SOPs and training materials for startup of the Norwood Facility
- Oversees execution of corrective and preventative actions (CAPA), deviations and change controls in support of the personalized vaccine unit.
- Closely partner with peers for rapid disposition of personalized cancer vaccines
- Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
- Enforce 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.
- Participate in quality oversite of manufacturing through real-time observations of activities
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 5- 8 years of experience in a GMP manufacturing environment or MS with 2-5 years of experience.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company.
- Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
- Exceptional written, oral communication, and organizational skills required
- Experience with tech transfer desired.
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
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.