Analytical Development Chemist

Long-Term Opportunity | R&D Experience | Pharmaceutical Company | Offers Benefits

Job Description

This role is ideal for a seasoned professional with deep expertise in oral solid dosage (OSD) forms and a passion for driving innovation in analytical development. As an Analytical Development Chemist, you will be responsible for leading the execution of analytical strategies, developing, validating, and transferring analytical methods, as well as evaluating and interpreting analytical results.

Responsibilities

• Lead the development and method validation or transfer strategy in alignment with customer requirements, ICH guidelines, and regulatory expectations, including method development, discriminatory dissolution methods, test method authoring, and method validation/transfer.
• Perform routine and non-routine analysis of development and stability samples.
• Represent the analytical development department at project team meetings and interface with both internal and external stakeholders.
• Ensure characterization of non-compendial reference standards is consistent with ICH guidelines and meets current FDA expectations.
• Partner with contract labs to perform testing as needed.
• Request and compare quotations and oversee testing of samples.
• Author test methods, validation protocols and reports, specifications, method development reports, risk assessments, company policies, departmental SOPs, and other related documents.

Essential Skills

• In-depth knowledge of ICH guidelines and pharmaceutical practices.
• Expertise in oral solid dosage forms.
• Proficiency in UPLC, HPLC, and GC.
• 10+ years of analytical chemistry experience.
• 4+ years of experience in the pharmaceutical industry with solid oral dosage forms or liquid suspension.
• Strong method validation skills.

Additional Skills & Qualifications

• Bachelor's degree in chemistry or related field with 10+ years of experience.
• Master’s degree with 8+ years of experience.
• Ph.D. with 6+ years of experience in analytical method development in the pharmaceutical industry.