Sr. Engineer I, Drug Product Process Development
Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory/pilot scale process development and leading mRNA formulation process technology transfers to internal and external GMP manufacturing facilities. Our team's goal is to define and implement robust commercial-scale manufacturing processes. This Senior Engineer role requires close working relationships with Analytical, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams. The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.
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, excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development accomplishments using QbD-principles and PAT with feedback control are strong pluses.
In this role, multi-day travel (up to 20%) should be expected to support technology transfer activities, including Person-in-Plant (PiP) support for Engineering and GMP batches.
Success in this role would be demonstrated by the implementation of robust scaled-up GMP processes and the delivery of released early- and late-phase bulk clinical supplies. This position bears the potential for significant growth in a dynamic organization.
Here's What You'll Do:
- Develop robust, scalable and well-characterized processes for the formulation of mRNA in lipid nanoparticles.
- Manage and execute transfer of mRNA formulation processes from process development labs to internal and external (CMO) GMP facilities to ensure timely GMP manufacture of clinical supply materials.
- Serve as SME Person-in-Plant for CMO manufacturing and support process-related troubleshooting. Employ industry-standard root cause analysis methodologies, as needed.
- Perform GMP activities with adherence to Quality Management System requirements.
- Prioritize work across many process development and manufacturing initiatives.
- Mentor junior team members. Supervisory role may be included.
- Communicate clearly with program stakeholders, technical staff and external CMO partners.
- Ensure high quality source documentation is generated to support regulatory filings.
Here's What You'll Bring to the Table:
- BS with a minimum of 8 years, or MS with a minimum of 5 years, of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.
- Demonstrable evidence of transferring established processes to internal or external partners.
- 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.
- Experience in independent project management.
- Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.
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.