What are the responsibilities and job description for the Senior Research Associate/Scientist I, LNP Downstream position at NewCo?
ABOUT US
Stealth Co was founded with a vision to unlock the potential of extrahepatic LNP for CGT across a broad range of modalities and therapeutic areas. We have deep expertise in extrahepatic LNP manufacturing processes which enable key partners and clients to advance their related programs from early R&D all the way to clinical trials. As a newly founded Stealth Co with signed deals with different partners/clients, we have ample funding to support our operation.
How will your role make an impact at our company?
Reporting to the Head of Platform, you will lead process development and scale up efforts across our lipid nanoparticle (LNP) platform and collaborate with analytical sciences CRO and our clients to support large-scale in vivo studies. You will require expertise at producing, characterizing and processing small-, mid- and large-scale LNP formulations.
Your Responsibility:
- Process development and scale-up of LNPs from milliliter to liter scale
- Provide formulation support for non-GLP large animal studies (e.g., exploratory toxicology, PK, and/or PD studies)
- Interact with external CDMOs and our clients to support process transfer, scale-up, and GxP manufacture
- Formulate and characterize LNPs
- Provide support for various QC activities for LNPs
- Maintain records of all relevant data in the electronic laboratory notebook system
Must-have Qualifications:
- BS ( 6 years experience), MS ( 5 years experience), or PhD ( 1 years experience) in an engineering or life sciences discipline
- Expertise in formulation and process development of LNPs at various scales
- Familiarity with common nanoparticle characterization methods
- Expert with tangential flow filtration (TFF) system
- Experience of JMP or Minitab (statistical software) used in Design of Experiments (DOE), Regression, Hypothesis & Testing, Quality Control Charts and Process Capability Statistics.
- Experience with different style pumps and LNP formulation methods
Desirable Qualifications:
- Experience with GxP manufacturing.
- Experience with process transfer to CDMO
- Experience with HPLC-MS and other analytical methods
Benefits
- Company-reimbursed Health, dental, and vision plans
- Paid Time Off
- Stock options
- Bonuses
- Parental leave
- We sponsor H1B Visa
