Senior Quality Control Chemist

General Description

The Senior Quality Control Chemist is responsible for assisting with the daily oversight and management of the Biovire laboratory. The Senior Quality Control Chemist excels at understanding, implementing, and improving current and future Quality Control workflows to ensure timely completion of Quality Control deliverables. The Senior Quality Control Chemist drives collaboration within the Quality Control department as well as interdepartmentally.

The Senior Quality Control Chemist has experience with a wide array of laboratory instrumentation techniques including, but not limited to, High Performance Liquid Chromatography, Gas Chromatography, Mass Spectroscopy, Karl Fisher Analysis, Total Organic Carbon Analysis, Viscosity Analysis, and Titrimetric Analysis.

DUTIES AND RESPONSIBILITIES

Essential Duties and Responsibilities:

1. Perform laboratory testing in compliance with regulatory requirements and internal procedures.

2. Support root cause analysis determinations for deviations and laboratory investigations.

3. Assist with training and mentorship of Quality Control personnel.

4. Learn, create, and implement new systems and programs as business, industry, and regulatory expectations grow and evolve.

5. Assist with raw material and stability programs.

6. Practice appropriate safety and analytical standards of excellence within the shared Biovire laboratory.

7. Practice applicable laboratory inventory and housekeeping programs within the shared Biovire laboratory.

8. Assist with equipment onboarding, calibration, and preventative maintenance programs.

9. Perform peer review of laboratory data.

10. Support Business Development, as necessary.

11. Adhere to all Biovire policies including, but not limited to, Quality, Human Resources, and Environmental Health and Safety.

12. Other duties as required or assigned by management.

Behavioral Expectations:

1. Strong work ethic and ability to accomplish tasks without supervision.

2. Demonstrate leadership both by words and leading by example to foster Biovire One Team culture.

3. Adhere to and follow all Company Policies and Procedures.

4. Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.

5. Basic computer skills (proficient in Microsoft Office applications).

6. Strong mathematical and organizational skills.

7. Excellent English communication skills, both written and verbal.

8. Must possess honesty, integrity, and a commitment to the highest legal and ethical standards.

9. Ability to treat every person with courtesy and respect.

10. Demonstrate ownership and accountability to production schedule without compromising product quality.

11. Knowledge of fundamental cGMP and regulatory principles such as deviations and CAPA.

Physical Expectations:

1. Frequent lifting, bending, stooping, squatting, pushing, and pulling.

2. Long periods of sitting and walking.

3. Long periods of sitting, typing, computer entry, or looking at a computer.

WORK EXPERIENCE AND education requirements

Minimum of 8 years of experience in the pharmaceutical industry.

Minimum of 6 years of experience using HPLC in a laboratory environment.

Four-year degree in Chemistry, Biology, or a related Life Science.

2-4 years of method development experience is preferred.

Working knowledge of standard software applications such as Chromatography Data Systems, Microsoft Office, and ERP. Working knowledge of Agilent OpenLab CDS or Agilent ChemStation is a plus.

Employment at Bryllan (Biovire) is contingent upon a successful Background check.