Scientist II, QC
About The Position
The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. The Scientist II, Quality Control - Nasal Drug Products is an advanced independent contributor responsible for execution, oversight, and technical problem-solving related to cGMP QC testing of nasal drug products, including raw materials, in-process materials, stability samples, and finished drug products.
Requirements
- Bachelor’s Degree in a scientific discipline with minimum of 6 years’ experience OR Master’s Degree in a scientific discipline with minimum 4 years’ experience in a GMP laboratory environment is required
- Strong working knowledge of GMP, GDP, data integrity principles, and regulatory expectations for QC laboratories is required
- Ability to evaluate trends, interpret complex datasets, and support scientifically defensible decisions is required
- Strong technical writing skills for QC documentation, investigations, methods, and validation deliverables is required
Nice To Haves
- Demonstrated experience with nasal drug products, inhalation products, or combination products is strongly preferred
Responsibilities
- Independently execute and lead routine to moderately complex cGMP QC testing for nasal drug products in accordance with approved test methods, SOPs, and regulatory expectations
- Perform and interpret analytical testing relevant to inhalation and nasal dosage forms, which may include physicochemical testing (e.g., pH, osmolality, viscosity), compendial testing, assay/impurity methods, and other product-specific analyses (e.g. spray testing), as applicable
- Serve as a technical resource for inhalation and nasal product testing, including troubleshooting assay performance, investigating atypical results, and proposing scientifically sound corrective actions
- Lead or support OOS, OOT, deviation, and investigation activities, including data evaluation, root cause analysis contributions, and technical documentation
- Author and support-controlled QC documents, including test methods, validation/transfer documentation, protocols, reports and investigation technical sections
- Other duties as assigned
Benefits
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits
- Tuition Reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
