Principal Research Associate, Drug Product Analytical Development
The primary responsibilities of this role will be to lead the testing of in-process controls (IPCs) using established analytical methods including both chemical separation and biophysical techniques to support large scale manufacturing process of messenger RNA therapeutic drug substances and drug products. The incumbent will be expected to undertake laboratory work and manage 1-2 direct reports to support the IPCs testing during the manufacture of critical non-GMP (GMP if needed) large scale batches including IND-enabling and Toxicology drug substance and drug product batches.
Additional responsibilities include troubleshooting analytical methods when required, trending analytical method performance, serving as a SME to support cross-functional groups including GMP quality control and preclinical production/QC groups, and supporting drug substance and drug product non-GMP/GMP investigations.
This role will be located in Norwood, MA. The individual will be a key contributor to large scale non-GMP drug substance and drug product manufacture at Moderna's new manufacturing facility in Norwood, MA.
Here's What You'll Do:
- Lead the analytical development team at Norwood to support program specific drug product and drug substance manufacture.
- Manage the testing of in-process controls to meet tight timelines by closely working with internal stake holders
- Undertake analytical testing using established methods to generate high quality data to support development and tox batch manufacturing process.
- Troubleshoot analytical instrumentation and methods as required, and trending analytical method performance.
- Provide data summary presentations and detailed tech reports to internal and external stake holders.
- Maintain good GLP lab and documentation practices.
- Potentially support implementation of new assays from analytical development, test method generation, and SME responsibilities supporting method transfers to QC.
Here's What You'll Bring to the Table:
- BS with relevant industry 6-10 years or MS with 3-6 years of experience.
- BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
- Knowledge and extensive hands-on experience of HPLC, modes of separation (e.g. ion exchange, reverse phase ion pairing, size exclusion) and DLS. Knowledge of biophysical techniques, GC/MS and LC/MS is a plus.
- Knowledge and extensive hands-on experience of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Empower and Openlab).
- Familiarity with electronic notebooks, LES and LIMS
- Knowledge of nucleic acid chemistry and biology and standard methods of analysis of these molecules
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
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 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
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.