Analytical Scientist III

Job Description

ForDoz Pharma Corp., based in East Windsor, New Jersey, is a fully integrated pharmaceutical company specializing in the development and manufacturing of advanced sterile injectable drug products. Rooted in a commitment to quality excellence, ForDoz continues to expand the expertise and production capacity for both conventional and complex sterile drug formulations in the U.S.

Role Description

The Analytical Scientist II is responsible for developing, validating, transferring, and troubleshooting analytical methods that support the development, manufacture, release, and stability of small molecule sterile injectable drug products. This position supports products throughout the development lifecycle, from early-stage R&D through clinical and commercial manufacturing. The ideal candidate has hands-on experience in a cGMP pharmaceutical laboratory, analytical method development and validation, and analytical testing of sterile injectable products.

Key Responsibilities

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• Develop, optimize, validate, and transfer analytical methods in accordance with ICH, USP, and FDA guidelines.
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• Perform analytical testing using HPLC/UPLC and other laboratory instrumentation for raw materials, in-process samples, and finished products.
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• Support stability studies, release testing, and product characterization.
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• Investigate analytical deviations, OOS/OOT results, and method-related issues.
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• Author and review analytical methods, validation protocols, reports, SOPs, and laboratory investigations.
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• Collaborate with Formulation, Manufacturing, Quality, and Regulatory teams to support product development and commercial manufacturing.
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• Ensure compliance with cGMP, data integrity, and laboratory safety requirements.
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Qualifications

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• EducationM.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline.
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• B.S. with significant relevant pharmaceutical experience may be considered.
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• Experience 3-5 years of pharmaceutical analytical laboratory experience.
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• Minimum 2 years supporting sterile injectable drug products.
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• Experience with small-molecule pharmaceuticals is required.
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• Experience with complex injectables (liposomes, suspensions, microspheres, emulsions, or long-acting injectables) is preferred.
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• Experience supporting IND, ANDA, or 505(b)(2) programs is a plus.
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• Experience in a cGMP pharmaceutical environment is required.
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Skills Required:

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• HPLC/UPLC (Empower preferred)
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• Analytical method development and validation
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• Stability testing
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• Method transfer
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• OOS/OOT investigations
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• ICH Q2 and USP analytical guidance
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• Strong analytical thinking and problem-solving skills
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• Excellent documentation and scientific writing ability
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• Effective communication across functions and with external clients
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• Ability to manage multiple projects and timelines independently
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• High attention to detail and commitment to quality
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Preferred:

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• LC-MS
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• Particle size analysis (DLS or laser diffraction)
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• Dissolution and release testing
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• LIMS or other electronic laboratory systems
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Pay$80,000 - $120,000 per year

Benefits

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

Why Join Us

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