Analytical Development Chemist

Benuvia Operations, LLC is a leading developer and manufacturer of high-purity, pharmaceutical cannabinoid ingredients and products. With state-of-the-art research, development, and manufacturing facilities in Round Rock, Texas, we offer comprehensive solutions for pharmaceutical, biotechnology, and consumer product companies.

PURPOSE

This is a full-time, on-site role for an Analytical Development Chemist located in Round Rock, TX. The Analytical Development Chemist primary roles include providing support in analytical testing of API and Drug Product Stability samples in support of the IND, NDA and ANDA submissions. Incumbents have responsibility for testing and data integrity, as assigned by management. Incumbents must be able to design and implement experiments based on an overall description of the intended outcome. Reports to the Analytical Development Manager.

DUTIES & RESPONSIBILITIES

• Primary role in method development and method validation.
• Conduct literature search and make recommendations for robust analytical methods for new product development.
• Screen various methods to implement validation of analytical methods for new products.
• Conduct analytical method validation in accordance with ICH guidelines.
• Write protocols and reports for method development and validations that are ready for submission to regulatory authorities.  
• Provide support in project management with contract manufacturing and testing facilities.
• Provide analytical testing support for new (solids, liquids, and spray) dosage forms.
• Help develop test specifications for new products.
• Routine testing for release of clinical study material.
• Ensure data integrity, conduct data collection and interpretation, and ensure proper documentation of experimental data. Maintain laboratory notebooks.
• Expertise in GMP laboratory requirements and compliance in accordance with relevant regulations.
• Manage site inventory. Order laboratory supplies and equipment. Maintain the laboratories and perform other job-related duties as assigned.
• Accumulate knowledge and skills to support development and management of research protocols in support of multiple drug discovery efforts.
• Achieve business goals, share learning’s, knowledge, and skills, and promote cross-functional teamwork.
• Use knowledge and experiences to interpret and properly document experimental data.
• Other work as assigned based on the project and company needs.

QUALIFICATIONS

• A PhD in Chemistry or related field with 1-3 years of relevant experience from basic research or the pharmaceutical industry preferred, or master’s degree in chemistry or related field with equivalent industry experience.
• Prior experience in handling analytical instrumentation such as HPLC, GC, UV/VIS.
• Prior Chromatographic Data Acquisition and LIMS Systems experience.
• Prior experience using spray testing and methodologies (spray pattern, plume geometry, etc.) is a plus.
• A high degree of computer proficiency and the ability/interest to learn new software programs required.
• Excellent skills in collecting data and accurately maintaining laboratory notebooks required.
• Expert level technical skills.
• Exposure to GLP/GMP laboratory and regulated industry is desirable but not required.
• Flexibility and the ability to work in a fast-paced, team-oriented environment.

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Must be able to conduct visual inspections of incoming materials to verify appearance and printed content (e.g. product labels) meet product specifications.
• Must accurately distinguish different colors for reporting of appearance and colorimetric tests.
• Occasional lifting of up to 50 lbs.