Scientist/Engineer, Personalized Vaccines Unit, Drug Product
At Moderna, we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. The Personalized Vaccines Unit (PVU) is focused on advancing Moderna's fundamental understanding of the science RNA and LNP production and translating it to the application of patient-specific manufacturing.
Moderna is seeking a highly skilled and motivated Scientist or Engineer to join our PVU group. The incumbent will lead a team of research associates to drive application of fundamental scientific and engineering principles to characterize our drug product formulations and processes, with a focus on the Personalized Cancer Vaccine. Working closely with the Formulation Development and Drug Product Process Science team, the applicant will lead the design and execution of experiments to identify and optimize critical formulation and process parameters and elucidate the impact of composition, formulation, process parameters, raw material attributes, materials of construction on drug product critical quality attributes and performance in key preclinical animal models, with a focus on fundamental understanding of the underlying intermolecular interactions and how they affect product quality. The applicant will also serve as a resource for technical evaluation of innovative process development solutions and a resource for investigation and resolution of issues identified during scale up and routine manufacturing
Here's What You'll Do:
- Using risk-based approaches and a deep understanding of chemistry and engineering principles, design and conduct experiments to identify and optimize critical process parameters and characterize early and late stage drug product manufacturing processes
- Develop and implement scale models of clinical and commercial processes and execute designed experiments to identify and control CPPs.
- Identify engineering solutions, including process analytical technologies, which lead to robust process control strategies
- Design and conduct experimentation to investigate the impact of raw materials and formulation parameters on drug product processes
- Provide technical support to resolve scale-up and manufacturing issues, develop solutions to improve product quality and process efficiency
- Prepare technical reports which support GMP production and form the basis of BLA submissions
- Provide input and review of responses to regulatory agency questions with regard to patient safety.
Here's What You'll Bring to the Table:
- PhD in Chemical Engineering, Chemistry or closely related field with 0-3 years of pharmaceutical or biopharmaceutical industry experience in development of manufacturing processes for biologics or other complex pharmaceutical drug products
- Experience leading and managing high-performing technical teams including objective setting, project management, goal tracking and progress communication to management
- Innovative scientist with ability to think critically and solve problems in laboratory and manufacturing settings
- Experience with nanoparticle formulation systems for large and small molecule delivery applications.
- Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges, as well as familiarity with optimizing product and process based on in vivo models.
- Experience with analytical tools for the characterization of drug product processes and products, particularly nanoparticle products.
- Familiarity with current industry standards for Quality by Design, including linking raw material attributes, formulation and process parameters to product Critical Quality Attributes (CQAs) through designed experiments, development of risk assessments and control strategies for drug product processes
- Familiarity with cGMP, ICH and regulatory guidelines as they relate to risk management and pharmaceutical development
- Excellent written and verbal communication skills
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.