What are the responsibilities and job description for the Analytical Development Scientist position at American Injectables?
About Us
American Injectables is a fast-growing pharmaceutical CDMO, dedicated to developing and manufacturing high-quality drug products. Our R&D Laboratory is seeking a detail-oriented and experienced Analytical Development Scientist to support analytical method development, validation, and transfer for multiple projects.
Job Summary
The Analytical Development Scientist will play a key role in developing, validating, and transferring analytical methods to support drug product development, manufacturing, and regulatory submissions. This role requires hands-on expertise with HPLC/UPLC, mass spectrometry (MS), and dissolution testing, along with experience in GMP compliance and regulatory guidelines. The ideal candidate will be comfortable working in cross-functional teams and with external CROs/CMOs to ensure successful execution of analytical activities.
Key Responsibilities
Analytical Method Development & Validation
- Develop, validate, and transfer analytical methods for raw materials, in-process materials, finished products, and stability studies.
- Perform hands-on bench work, including HPLC/UPLC method development, impurity identification with mass spectrometry (MS), and method transfer/validation.
- Troubleshoot and optimize analytical methods, applying strong problem-solving skills.
- Design and execute analytical studies, analyze data, interpret results, and prepare study protocols and reports.
Regulatory & Compliance Support
- Prepare and review regulatory submission documents, including responses to regulatory deficiencies.
- Ensure compliance with cGMP, FDA, ICH guidelines, and compendial requirements (USP/NF, EP).
- Maintain accurate laboratory records in accordance with Good Documentation Practices (GDP).
Cross-Functional Collaboration & Project Support
- Represent analytical development in cross-functional teams, ensuring alignment with project objectives.
- Collaborate with manufacturing, quality, and automation teams to support method development and transfer.
- Work with CROs/CMOs to coordinate external analytical testing as needed.
Laboratory Operations & Safety
- Assist in laboratory instrument maintenance and troubleshooting.
- Adhere to health, safety, and environmental requirements.
- Occasionally work extended hours based on project needs.
Qualifications & Skills
Required Skills & Abilities
- Strong experience with HPLC/UPLC, GC, mass spectrometry (MS), and dissolution testing.
- Familiarity with physicochemical characterization techniques such as particle size analysis, TGA, and DSC.
- Knowledge of FDA, ICH guidelines, and compendial methods (USP/NF, EP).
- Ability to work independently and collaboratively in cross-functional teams.
- Strong problem-solving, data analysis, and organizational skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) for documentation and reporting.
- Excellent written and verbal communication skills for report writing and presentations.
Education & Experience
- M.S. in Chemistry, Analytical Chemistry, or a related field with at least 2 years of relevant pharmaceutical R&D experience.
- B.S. in Chemistry or a related field with at least 5 years of relevant experience.
- Strong candidates with equivalent education and experience combinations will be considered.
Other Requirements
- Must be eligible to work in the USA.
Why Join Us?
- Be part of an innovative pharmaceutical CDMO with cutting-edge R&D projects.
- Work in a collaborative and dynamic environment, supporting high-impact drug development.
- Competitive salary, benefits, and opportunities for career growth.
