Principal/Sr. Engineer Process Development
Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong process development background in the regulated (bio)pharmaceutical environment. Our team's goal is to envision, pilot, scale, characterize, transfer and validate robust commercial GMP manufacturing processes. This is a lab-based role with possible supervisory responsibility for high-performing junior team members.
We are establishing novel processes that require a solid practical foundation in standard bioprocess unit operations (e.g. batch and/or single-pass TFF, normal flow filtration, mixing systems, chromatography). These skills should be complemented with a track record of effective troubleshooting, time management and written and oral communication skills as well as experience operating within a Quality Management System.
Success in this role would be demonstrated by the establishment of a validated PAI-ready manufacturing process. This Senior Engineer role requires close working relationships with Analytical, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions.
Here's What You'll Do:
- Develop robust, scalable and well-characterized processes for the manufacture of mRNA medicines using QbD principles.
- Manage and execute transfer of production processes from development labs to GMP facilities on rigid timelines.
- Specify and support the procurement of manufacturing equipment (possibly custom)
- Establish scale-down process models and perform process characterization utilizing DOE principles.
- Author BLA content associated with process development and validation
- Ensure high quality source documentation is generated to support regulatory filings.
- Prioritize work across multiple process development and manufacturing programs.
Here's What You'll Bring to the Table:
- BS with a minimum of 10 years, or MS with a minimum of 8 years, of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.
- Strong background in process technology transfer (sender or receiver).
- Strong leadership, prioritization and project management skills.
- Ability to effectively document and communicate results.
- Experience in large molecule process development (late phase-preferred).
- Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.
- Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.
- Process development accomplishments using QbD-principles.
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.