Scientist - Analytical Development - Pharmaceutics

Scientist 1

UPM Pharmaceuticals is an independent, highly experienced and award winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability. Currently, UPM is accepting open applications for a Scientist 1 within the company.

Summary: Under the direction of analytical development management, performs analytical method transfer, optimization, development and validation. With support, develops protocols and conducts experiments using wet chemistry and appropriate laboratory equipment; conducts testing on drug substance, drug products and stability samples in support of drug development and manufacturing. Collects and interprets analytical data and writes reports in accordance with laboratory SOPs. Performs the role of lead chemist on multiple projects. Assists in training and mentoring of other analysts.

Essential Duties and Responsibilities:

1. Assists with analytical method transfer, optimization, and development/validation design and analytical methods development/validation of drug substances, drug product and residual testing, using guidelines from USP and ICH.

2. Supported development of protocols under which the methods transfer, optimization, and development are conducted and executes such protocols.

3. Evaluates statistically the validation data and writes the method validation report for submission.

4. Writes test methods into company SOPs; reviews, writes, or assists in writing SOPs for analytical development.

5. Performs USP Compendial testing and other Compendial testing as required.

6. Consults with scientific professionals and scientific literature for problem solving assistance.

7. Provides analytical testing support for manufacturing process validation.

8. Documents laboratory activity and files all data using appropriate log books, records, files, and equipment calibration logs.

9. Observes safety rules and assists in keeping the laboratory a safe environment.

10. Operates laboratory equipment such as balances, pH-meters, hardness testers, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs.

11. Performs routine sample processing and dosage form analysis using HPLC and UV-Vis analysis equipment.

12. Collates test results and prepares certificates of analysis and stability reports.

13. Conducts peer reviews, as required, of other scientists work prior to submission to quality assurance.

14. Performs other duties as required.

Education/Experience:

Bachelor’s degree in Chemistry or related scientific filed with at least 4 years of analytical chemistry experience. Advanced degree preferred. Pharmaceutical laboratory experience preferred. Equivalent combination of education and experience o

Job Type: Full-time

Pay: From $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Relocation assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• No nights

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Development / Validation: 2 years (Required)

Work Location: One location