Senior Analytical Scientist

Job Title

Senior Analytical Scientist

Location: East Windsor, NJ (On-site)

Reports To: Head of Analytical Development / Quality Control / R&D

Position Summary

The Senior Analytical Scientist is responsible for the development, validation, and transfer of analytical methods to support the development, manufacture, release, and stability of injectable drug products. This role supports complex and sterile injectable dosage forms, including solutions, suspensions, liposomes, microspheres, and long-acting injectables, across all stages of development—from early R&D through clinical and commercial manufacturing.

The position requires strong hands-on laboratory experience, deep understanding of analytical techniques, and the ability to work cross-functionally with Formulation, Manufacturing, Quality, and Regulatory teams in a cGMP environment.

Key Responsibilities

Analytical Method Development & Validation

• Develop, optimize, and validate analytical methods for raw materials, in-process samples, drug substance, and drug product.
• Perform method validation and verification in accordance with ICH, USP, and FDA guidelines.
• Support method transfer to QC laboratories and external testing laboratories.

Injectable Product Testing & Characterization

• Conduct analytical testing for injectable products, including:
• Assay and related substances (HPLC/UPLC)
• Particle size distribution (DLS, laser diffraction, microscopy)
• Encapsulation efficiency and drug loading
• Release testing and dissolution
• pH, osmolality, viscosity, and appearance
• Support sterility, endotoxin, and particulate matter testing in collaboration with Microbiology/QC teams.

Stability & Release Support

• Design and execute stability studies for clinical and commercial products.
• Evaluate stability data and trend results to support shelf-life assignments.
• Perform release testing for GMP batches and support OOS/OOT investigations.

GMP, Compliance & Documentation

• Author and review analytical SOPs, protocols, reports, and test methods.
• Ensure analytical activities comply with cGMP, data integrity, and laboratory safety requirements.
• Support internal audits, FDA inspections, and regulatory inquiries.

Regulatory & CMC Support

• Contribute to analytical sections of CMC documentation for IND, ANDA, NDA, and 505(b)(2) submissions.
• Provide scientific justification for analytical strategies and specifications.

Troubleshooting & Continuous Improvement

• Investigate analytical deviations, OOS/OOT results, and method-related issues.
• Recommend improvements to methods, controls, and laboratory practices.
• Support continuous improvement initiatives to enhance efficiency and compliance.

Leadership & Collaboration

• Mentor junior analysts and scientists.
• Serve as analytical lead on assigned development or CDMO projects.
• Collaborate with Formulation, Manufacturing, Quality, and external partners to ensure analytical readiness.

Qualifications

Education

• M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline

(B.S. with extensive relevant experience may be considered)

Experience

• Senior Scientist: 6–10 years of relevant pharmaceutical analytical experience
• Strong experience with injectable drug products required
• Experience with complex formulations (liposomes, microspheres, suspensions, emulsions, long-acting injectables) highly preferred
• Experience supporting IND, ANDA, or 505(b)(2) submissions is a strong plus
• Prior experience in a cGMP and/or CDMO environment preferred

Technical Skills

• Extensive hands-on experience with HPLC/UPLC; knowledge of LC-MS is a plus
• Experience with particle size analysis, release testing, and physical characterization
• Strong understanding of ICH Q2, USP <621>, <711>, <788>, <85>, and related guidance
• Familiarity with stability testing protocols and data trending
• Knowledge of data integrity and electronic laboratory systems (e.g., Empower, LIMS)

Soft Skills

• Strong analytical thinking and problem-solving skills
• Excellent documentation and scientific writing ability
• Effective communication across functions and with external clients
• Ability to manage multiple projects and timelines independently
• High attention to detail and commitment to quality

Why Join Us

• Work on advanced injectable and drug delivery technologies
• Hands-on involvement across development, manufacturing, and commercialization
• Exposure to regulatory filings and FDA interactions
• Collaborative environment with opportunities for growth and leadership

ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics

Job Type: Full-time

Pay: $80, $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $150,000