Formulation Scientist - Analytical & Drug Product Development

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, 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 scaling up formulation processes. 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.

Regulatory and Compliance

• Prepare and review SOPs, protocols, technical reports, development reports, and batch records.
• Knowledge of preparation of CMC sections for:
• • INDs
  • NDAs
  • ANDAs
  • 505(b)(2) applications
  • BLAs
• Knowledge of compliance with GMP, GLP, FDA, EMA, and ICH guidelines.
• Support regulatory audits and client inspections.

Project Leadership and Innovation

• Serve as scientific subject matter expert for formulation and analytical development projects.
• Interface directly with clients, consultants, and regulatory authorities.
• Define project scope, timelines, budgets, and technical deliverables.
• Identify emerging formulation technologies and industry trends.
• Contribute to invention disclosures, patent applications, scientific publications, and presentations.
• Mentor junior scientists and support a collaborative scientific environment.

Required Qualifications

Education

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Chemistry, Chemical Engineering, Pharmaceutics, or related discipline.

OR

• M.S. with 5 years of relevant pharmaceutical industry experience.

Experience

• 3-8 years of experience in formulation development and analytical development within the pharmaceutical or biotechnology industry.
• Experience with biologics, peptides, proteins, biosimilars, or complex pharmaceutical products.
• Experience developing injectable, oral, liquid, sustained-release, and/or lyophilized dosage forms.
• Experience in analytical method development, validation, and troubleshooting.
• Experience in process development, technology transfer, and manufacturing support.

Preferred Qualifications

• Experience in developing injectables for antibody, protein, bispecific, small molecules biosimilar, oligonucleotide etc.
• Knowledge in injectable requirements
• Knowledge of nanoparticle, polymeric, lipid-based, or advanced drug delivery systems.
• Experience supporting patent filings and intellectual property generation.
• Prior experience interacting with regulatory agencies.
• Startup biotech or CDMO experience preferred.

Core Competencies

• Scientific innovation and creativity.
• Strong analytical and problem-solving skills.
• Excellent experimental design and data interpretation abilities.
• Project management and organizational skills.
• Strong written and verbal communication skills.
• Ability to manage multiple projects simultaneously.
• Excellent teamwork and client-facing capabilities.
• Strong attention to detail and commitment to quality.

If you have the required experience and skills to succeed, and you are seeking a challenging opportunity in a growing company with a dynamic culture, send your resume.

CuriRx is an equal opportunity employer and supports workplace diversity, a reduced carbon footprint, and fun.

CuriRx, Inc. was founded in 2012, a contract research, development, and manufacturing organization (CRDMO) specializing in biologics, gene therapy, cell therapy, and advanced drug delivery solutions. Our vision is to create 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. The company provides end-to-end services including process development, analytical testing, formulation development, GMP manufacturing support, and regulatory assistance for biotechnology and pharmaceutical clients.