Formulation Scientist – Analytical & Drug Product Development
Company
CuriRx, Inc. was founded in 2012 with the goal of creating new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars. CuriRx focuses on formulation and lyophilization development of biologics, small molecule, analytical development, and preclinical manufacturing of biologics.
Job Description
CuriRx, Inc. is seeking an innovative and highly motivated Formulation Scientist with a strong analytical background to support the development of novel biologics, pharmaceuticals, biosimilars, and advanced drug delivery systems. The successful candidate will be responsible for executing experiments by designing and implementing formulation development strategies for injectable, oral, liquid, sustained-release, and lyophilized dosage forms while utilizing advanced analytical techniques to characterize products and optimize formulation performance.
This position requires expertise in analytical method development, formulation science, pharmaceutical process development, and regulatory compliance. The scientist will work closely with clients, contract manufacturing organizations (CMOs), regulatory agencies, and cross-functional teams to accelerate product development from concept through commercialization.
Duties and Responsibilities
Essential Duties and Responsibilities
Formulation Development
- Design, develop, and optimize formulations for biologics, peptides, proteins, biosimilars, and pharmaceutical products.
- Develop injectable, oral, sustained-release, liquid, and lyophilized dosage forms.
- Conduct preformulation studies, excipient compatibility assessments, and formulation screening.
- Design and execute studies using Quality by Design (QbD) and Design of Experiments (DOE) methodologies.
- Lead formulation optimization, scale-up, technology transfer, and manufacturing support activities.
- Develop innovative drug delivery technologies to improve product bioavailability, stability, and patient compliance.
- Support formulation development for generic products, 505(b)(2) products, and novel therapeutics.
Analytical Development and Characterization
- Design, develop, qualify, and validate analytical methods.
- Troubleshoot analytical methods and independently interpret complex analytical data.
- Utilize analytical instrumentation including:
- HPLC/UPLC
- SEC-HPLC
- LC-MS/MS
- UV-Visible Spectroscopy
- Fluorescence Spectroscopy
- ELISA
- Plate Readers
- Dynamic Light Scattering (DLS)
- Moisture Analysis/Karl Fischer
- Particle Size Analysis
- Establish stability-indicating methods and evaluate degradation pathways.
- Generate analytical reports and effectively communicate scientific findings.
Process Development and Manufacturing Support
- Support process development, process optimization, and process validation activities.
- Develop and optimize lyophilization cycles for biologic and pharmaceutical products.
- Participate in scale-up and technology transfer to manufacturing facilities.
- Evaluate and implement new equipment and emerging technologies.
- Collaborate with CMOs and CROs to ensure successful execution of development programs.
Regulatory and Compliance
- Prepare and review SOPs, protocols, technical reports, development reports, and batch records.
Pay: $80,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
