Quality Control​/Analytical Development Specialist

Position: Quality Control / Analytical Development Specialist
Job Title:

Quality Control / Analytical Development Specialist

Job Description

In this role, you will be instrumental in developing analytical methods, characterizing proteins, and assisting in the formulation development and stability programs for drug substances and drug products. You will collaborate with a team to enhance analytical and formulation development as well as stability processes. This laboratory position requires a hands-on approach and the ability to work independently while reporting to an Analytical Scientist.

Familiarity with GxP lab practices, including good documentation practices, is essential. Routine analytical testing in a quality-regulated environment is also part of this position.

Responsibilities

+ Perform analytical sample analysis to support process development using techniques such as ELISA, HPLC, and UV-Vis.

+ Utilize tools like Empower and Waters/Thermo Fisher HPLCs, and plate readers.

+ Aid in analytical testing for release and stability testing of drug substances, intermediates, and drug products.

+ Assist in drafting test methods for routine sample analysis.

+ Identify analytical science capabilities and technology tools necessary for research, manufacturing, process development, QC testing, and new drug candidate formulation development.

+ Maintain and organize the laboratory environment, including samples, reagents, and instruments.

+ Support analytical method transfer, qualification, and validation for commercial QC and contract laboratories as needed.

+ Develop scientifically sound, data-driven specifications.

+ Prepare and deliver technical reports, documents, batch analyses, analytical methods, and reference standards for regulatory submissions.

Essential Skills

+ Knowledge of cGMP, GxP, and analytical instrumentation.

+ Experience in analytical method development, transfer, qualification, and validation.

+ Experience applying GxP/GLP/GMP standards based on project and sample type with a risk-based compliance mindset.

+ Proficiency with multi-instrument analytical techniques (HPLC, ELISA, plate-based assays) in fast-paced, multi-project environments.

Additional

Skills & Qualifications

+ A passionate, go-getter attitude that thrives in a fast-paced, team-oriented environment.

+ Experience in handling multiple projects with varying levels of GLP simultaneously is preferred.

+ Applicable professional experience is preferred over educational background, with consideration for candidates with an Associate degree.

Work Environment

The work environment is fast-paced and team-oriented, where collaboration and adaptability are key.

Job Type & Location

This is a Contract position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and Hospital - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability
- Health Spending Account (HSA) - Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Durham,NC.

Final date to receive…