What are the responsibilities and job description for the Method Development Engineer position at Consumer Product Partners?
Job Title: Analytical Chemist/Methods Engineer
About Us:
We are a leading OTC Drug and Cosmetics manufacturer with an Employee Stock Ownership Plan. We seek a dedicated and experienced Analytical Chemist/Methods Engineer to join our team.
Key Responsibilities:
- Method Development: Design, develop, validate, and verify analytical methods for testing raw materials, finished products, stability, and process validation.
- Compliance Testing: Conduct analysis of Active Pharmaceutical Ingredients (APIs), excipients, and finished drug products according to company SOPs, cGMPs, GLPs, GDPs, and FDA/DEA/OSHA regulations.
- Protocol Execution: Develop and execute protocols, reports, and test methods related to raw material and finished product testing.
- Laboratory Support: Provide technical expertise to support laboratory investigations and method transfers between facilities.
- Equipment Operation: Operate and troubleshoot routine laboratory equipment, including Gas Chromatography (GC), Liquid Chromatography (LC/HPLC/UPLC), and Inductively Coupled Plasma (ICP).
- Data Analysis: Utilize Empower software for data analysis and method development.
- Regulatory Compliance: Ensure compliance with FDA Regulations, USP/NF monographs, and ICH guidelines.
Requirements:
- Education: Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, or food science with coursework in analytical chemistry.
- Experience: Minimum of 3 years of laboratory experience in method development, validation, verification, and transfer activities for pharmaceutical raw materials and finished products.
- Skill Set: Proficiency in operating laboratory instrumentation and conducting statistical analysis.
- Knowledge: Strong knowledge of USP, FDA, and ICH guidelines.
- Communication: Effective communication skills and ability to work independently with minimal supervision.
- Project Management: Proven ability to organize projects and complete tasks in a timely manner.
PREFERRED SKILLS:
- Software Proficiency: Proficiency in Empower software.
- Self-Motivation: Self-motivated with the ability to work independently and within a team.
- Organizational Skills: Strong organizational skills and attention to detail.
