Chemist III, Drug Product Laboratory in Bristol, Tennessee at Gregory Pharmaceutical Holdings Inc

JOB DESCRIPTION

Job Title: Chemist III, Drug Product Laboratory

Reports To: QC Laboratory Manager

Department: Quality Control

Summary:

Under the direction of QC Laboratory management, the Chemist III serves as a high-level technical analyst with demonstrated mastery of all routine analytical testing procedures. Performs independent validation and qualification testing with a high degree of accuracy and minimal supervision. This position requires a continuation of structured training to achieve proficiency in Standard Operating Procedures (SOPs), and analytical test methods. Provides training and technical guidance to junior analysts as assigned, with limited oversight from management. This professional-level position is characterized by advanced technical expertise, strong technical writing capability, and effective time management. Advancement to this level is based on demonstrated proficiency in method validation and qualification studies, effective technical troubleshooting, and consistent adherence to cGMP and data integrity requirements.

Essential Duties and Responsibilities:

The essential functions of this position may include, but are not limited to:

1. Independently performs routine analytical testing of in-process, finished product, and stability samples following approved specifications and Standard Operating Procedures (SOPs) with a level of mastery, serving as a point of contact for technical troubleshooting. This may include but is not limited to moisture testing, Content Uniformity testing, Assay testing, Related Substances testing, Dissolution testing, and the use of HPLCs, UPLCs, and GCs.
2. Perform USP Compendial testing and other Compendial testing as required.
3. Demonstrates proficiency in wet chemistry testing, Empower chromatography software, LIMS software, and general laboratory skills with a high level of mastery.
4. Completes testing with a high degree of efficiency, reliability, and accuracy.
5. Responsible for training Chemist I and Chemist II staff on routine laboratory methods and procedures in the lab with minimal management oversight, ensuring technical consistency across the team.
6. Performs independent execution of validation testing and qualification studies with high precision.
7. Maintains the quality control laboratory and standard laboratory equipment. This may include, but is not limited to, maintenance, calibration, and use of standard laboratory equipment.
8. Records and reports test data correctly and accurately within company guidelines.
9. Performs assigned work in a timely manner, conforming to regulatory, company, and compendial requirements.
10. Actively assumes responsibility in adhering to site standard SOPs and federal regulations.
11. Knowledge of company and departmental policies pertaining to cGMP, cGLP, safety, health, security, and departmental operation. Complies with company and departmental regulations, policies and guidelines while performing duties of the job.
12. Recognizes trends and deviations, promptly reporting them to laboratory management.
13. Assists appropriate staff in Laboratory Investigation Reports (LIRs) and Notice of Events (NOEs).
14. Performs other duties as required.

Knowledge Necessary to Perform the Job:

1. Thorough knowledge and understanding of quality control principles, chemistry, and techniques.
2. Ability to effectively communicate status of testing to management.
3. Advanced knowledge in the operation of modern analytical instrumentation.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Analytical:

Collects and evaluates data; analyzes information skillfully by applying good scientific judgement; maintains accurate / concise records with attention to detail.

Problem Solving:

Supports the team in the troubleshooting and resolution of technical issues.

Technical Skills:

Ability to operate analytical balance, computer, HPLC, pH meter, Karl Fischer, Specific Gravity, and other modern analytical equipment.

Oral/Written Communication:

Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel. Completes documents / logs clearly and accurately.

Ethics/Professionalism:

Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor. Treats others with respect and consideration regardless of their status or position.

Organizational Support:

Supports organization’s goals and values. Follows policies and procedures.

Adaptability:

Ability to deal with frequent changes to schedules, delays, or unexpected events.

Attendance/Punctuality:

Maintains regular and punctual attendance.

Initiative:

Meets challenges with resourcefulness. Proactively identifies and resoles issues which have the potential to affect analytical operations or schedules.

Quality:

Produces analytical work of high quality. Observes company quality policies and procedures.

Safety and Security:

Observes safety and security procedures. Responsible for meeting department safety objectives and follow on-going safe operating procedures consistent with the job requirements.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor’s degree in Chemistry or a related scientific field. 4-10 years of prior laboratory or relevant professional experience is preferred but not required. An equivalent combination of education, training, performance, and experience may be considered.

Language Ability:

Ability to read and understand applicable compendial methods, SOPs, general business periodicals, professional journals, technical procedures, and/or government regulations.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure using whole numbers, common fractions, and decimals.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have basic computer skills with knowledge of Word, Excel, Access, Outlook and ability to use internet tools.

Work Environment and Physical Demands:

The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts and working with general laboratory chemicals with proper safety equipment. The employee is occasionally required to stand, walk, sit; use fingers to handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus and ability to distinguish colors.