Sr. /Research Associate, Drug Product Analytical Development
The primary responsibilities of this role will be to support development and conduct of analytical methods for messenger RNA therapeutic drug substance and lipid nanoparticle drug products. The incumbent will be expected to undertake laboratory work to support testing and data collation. Additional responsibilities include developing high throughput methods using liquid handling and end-to-end sample tracking for drug substance/product components and impurities. This position will support cross-functional teams in Research and Development, Production and Quality. Additionally it is expected that the role will require the individual to generate technology transfer documents and enable the physical transfer of methods to receiving groups as part of a broader functional responsibility.
Here's What You'll Do:
- Undertake analytical testing using established methods to generate high quality data to support process development.
- Develop high throughput methods in collaboration with supervisor and perform verification and validation experiments.
- Work with digital teams to enable end-to-end sample tracking from submission to final report of submissions.
- Write analytical method SOP's and train personnel on methods as needed.
- Provide summary presentations and detailed reports to internal and external stake holders.
- Maintain and troubleshoot equipment performance as needed.
- Technology transfer of high throughput analytical methods to receiving partners, e.g. preclinical QC, non-GMP and GMP stability).
- Provide subject matter expertise to support functions for methods that have been transferred.
Here's What You'll Bring to the Table:
- A BS with ~ 2-5 years of experience or MS with 0-2 years of relevant industry or undergraduate experience in analytical chemistry.
- BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
- Knowledge of HPLC and modes of separation (e.g. ion exchange, reverse phase ion pair, size exclusion), biophysical characterization, and spectrophotometric techniques (UV, fluorescence).
- Knowledge of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Chemstation, Empower).
- Knowledge of nucleic acid chemistry and biology and standard methods of analysis of these molecules.
- Hands on industry experience with analytical development for RNA and DNA therapeutics
- Knowledge of GMP and GLP regulations and guidance on analytical method validation (ICH Q2 (R1)
- Demonstrable evidence of enabling high throughput analytical methods, including the use of liquid handlers/automation (e.g. with Hamilton or Tecan Robots)
- Experience in the characterization nucleic acid products (plasmid DNA, RNA, oligonucleotides), particularly those formulated as liposomes or nanoparticles.
- Some experience of one or more of the following areas is a plus: Mass spectrometry, CD, CGE, IEF, GC.
- Experience with compendial microbial testing methods or rapid sterility / bioburden testing.
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.