Principal Research Associate, Drug Product Analytical Development
Moderna is looking to recruit a highly motivated Principal Research Associate with a strong analytical chemistry background to develop and characterize novel and existing methods in support of our Personalized Cancer Vaccine program. The position will be focused upon conducting analytical characterization of product intermediates and final formulated lipid nanoparticles (LNPs), as well as implementing novel process characterization methodologies as required to support the Process Development teams to optimize drug product manufacturing process. Additional responsibilities will include troubleshooting and improving analytical method performance, as well as assisting method transfer and performance monitoring at both Contract Testing Organizations as well as internal QC groups. This is a predominantly laboratory based role, and the incumbent will be expected to work on time-bound projects with defined deliverables, and to perform experimental work in accordance with industry best practices and external regulatory requirements for method development and validation.
Here's What You'll Do:
- Provide analytical chemistry based method development support to drug substance, formulation development and drug product release, using standard platforms such as HPLC / UPLC, Capillary Electrophoresis and spectrophotometric/ colorimetric endpoints.
- Collaborate with the Process Development function to characterize the drug product manufacturing process.
- Assess emerging analytical technologies and determine their applicability and utility in the assessment of novel mRNA drug products.
- Troubleshoot current analytical methods and determine any required revisions as processes and scales evolve.
- Transfer robust analytical methodologies to internal QC groups or external CRO's.
- Qualify / validate appropriate methodologies per ICH Q2 (R1) requirements for routine use.
- Provide any routine testing support as needed to enable project progression.
- Generate high quality documentation to support regulatory filings.
Here's What You'll Bring to the Table:
- Bachelor's degree with minimum 5 years of industry experience in analytical chemistry allied to the characterization of complex formulated biological or small molecule products.
- Experience in analytical techniques including spectroscopy (UV, Fluorescence, CAD), separation techniques (UPLC, HPLC, CE) and biophysical characterization (e.g. DLS, DSC, CD, NTA, and Coulter Counter)
- Demonstrated experience with technology transfer of established methods to internal or external partners.
- Demonstrate strong experience with trouble shooting analytical datasets and methodologies
- Prior responsibility for the management of outsourced activities and management of CMO's/CRO's.
- Ability to effectively document and communicate results.
- Experience in early phase (PhI / PhII) drug development.
- Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.
- Knowledge of the regulatory environment, particularly ICH, guidelines on analytical method development and validation and application of USP and Ph. Eur. methods.
- Must be independent and able to proactively apply knowledge in the design, execution and qualification of analytical methodologies.
- Master's degree with 5 + years' of industry experience
- 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.