Quality Control Method Development Chemist

**Similar Industry Experience in a Food or Dietary Supplement Manufacturing Lab Setting is Required for this Position**

Position Summary:

The primary function of the Method Development Chemist is to provide analytical chemistry support.. This motivated individual works as part of a team analyzing raw materials, in-process materials, and development products for chemical/physical stability. The Chemist will aid in the development of analytical techniques to assist the formulation development of new drug products/dietary supplements.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Completes projects by assisting the project team; attending and participating in group and project meetings.

· Aids in the development and validation of analytical methods.

· Compiles and analyzes test information to determine chemical stability of development products and processes.

· Keeps equipment functional by following operating instructions; troubleshooting breakdowns; maintaining equipment and supplies; performing preventive maintenance; calling for repairs.

· Ensures data is properly and accurately recorded in laboratory notebooks in accordance with industry guidelines and regulations.

· Develops and maintains effective organization and time management through use of effective record keeping.

· Systematically records, interprets and analyzes data; Prepares reports to document findings and recommendations in a timely manner.

· With minimal supervision the Chemist must resolve problems by examining and evaluating data; selecting corrective steps.

· Enhances laboratory and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

· Maintains awareness of technical developments in the field and of product/process improvements and patent opportunities.

· Analyzes raw materials, intermediate preparations and finished goods to determine quality, safety, stability, compatibility, efficacy and nutritional value utilizing chromatography, spectroscopy and other analytical techniques.

· Meets safety requirements in accomplishing responsibilities of this position in compliance with all policies or regulations.

· Review and update test methods and procedures according to SOPs.

Providing support training and performing other similar or related duties as necessary.

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

Continuous Learning – Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.

Innovation – Displays original thinking and creativity. Meets challenges with resourcefulness. Generates suggestions for improving work. Develops innovative approaches and ideas.

Planning and Organization – Integrates changes smoothly. Plans for additional resources. Prioritizes and plans work activities. Sets goals and objectives. Uses time efficiently. Works in an organized manner.

Problem Solving – Develops alternative solutions. Gathers and analyzes information skillfully. Identifies problems in a timely manner. Resolves problems in early stages. Works well in group problem solving situations.

Use of Technology – Demonstrates required skills. Adapts to new technologies. Troubleshoots technological problems. Uses technology to increase productivity. Keeps technical skills up to date.

Qualifications:

Education/Experience –

· Bachelor of Science in Chemistry, Biology, or related discipline is required. 2 years previous practical laboratory work experience in pharmaceutical and/or dietary supplements required. (Preference for Master of Science)

· Strong knowledge of the testing and properties of amino acids, fatty acids, fat-soluble and water-soluble vitamins, ubiquinol coenzyme Q10, enzymatic activity, elemental analysis, material chemical and accelerate digestion techniques, drug product formulations and analytical instrumentation and the ability to use knowledge gained from scientific research to develop methods, SOPs, and procedures.

· Excellent interpersonal skills and ability to work effectively in a team environment.

· Good organizational skills and ability to manage others in job duties.

· Ability to work independently and problem-solve.

· Must have knowledge of Regulatory Compliance – FDA, cGMP, cGLP.

· Extensive laboratory equipment experience preferred, e.g. ICP-MS, ICP-OES, GC-MS, UV-VIS, HPLC, UHPLC, HPTLC.

· Measurement and wet chemistry sample preparation techniques.

Language Ability – Read, analyze and interpret business, professional, technical or governmental documents. Write reports, business correspondence and procedure manuals. Effectively present information and respond to questions from managers, customers and the public.

Mathematical Ability – Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Compute rate, ratio and percent, and draw and interpret bar graphs. Ability to perform complex mathematical operations, such as decay rates, molarity calculations, and interpret raw data and present it in a meaningful way to aid in the product development process.

Reasoning Ability – Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills – Working knowledge of chromatography software such as Empower, Chemstation, and Turbochrom. Intermediate Knowledge of Microsoft Office Suite, Internet Explorer and email. LIMS experience is a plus.

Certificates and Licenses – None required.

Supervisory Responsibilities: This job has no supervisory responsibilities.

Work Environment: The work environment characteristics 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 the work environment is usually moderate.

Work environment involves moderate risks or discomforts which require special safety precautions, e.g., working around moving machines in production facilities, handling of hazardous testing and sanitation chemicals. Protective clothing or gear such as goggles, gloves and shoes may be required. Aerosolized product powder levels may occur during sample preparation.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus.

Work also requires some physical strain such as long periods of standing and walking in production facility and lifting of moderately heavy items such as test equipment kits and product cases. Other physical demands include climbing, crouching, and reaching.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Job Type: Full-time

Pay: From $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Education:

• Bachelor's (Required)

Experience:

• Method Development Chemistry: 2 years (Required)
• Practical Lab work (Food, Pharma, Nutraceutical MFG industry: 2 years (Required)
• ICP-MS: 2 years (Required)
• HPLC: 2 years (Required)

Language:

• English (Preferred)

Ability to Relocate:

• Fort Worth, TX 76155: Relocate before starting work (Required)

Work Location: In person

Salary : $70,000