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