QA Operations Consultant (Contract - Remote - Part-Time)

ProPharma Group; Overland Park (KS); Remote; USD 60,000 - 80,000; Part time

Job summary

A leading company in life sciences is contracting for a Consultant position focused on Technical QA oversight related to gene therapy and biologics. This remote role involves conducting reviews and ensuring compliance throughout the drug production process. Ideal candidates should possess direct experience in gene therapy, particularly with mammalian cell culture and drug product manufacturing. The opportunity supports diverse and innovative team members aiming for impactful contributions.

Qualifications

• Strong preference for direct gene therapy or biologics experience.
• Experience from starting materials to clinical distribution.
• Expertise in mammalian cell culture, purification, and drug product manufacturing.

Responsibilities

• Provide Technical QA oversight including batch record review.
• Review deviations, change controls, and testing.
• Oversee CDMO engagements.

Skills

Gene therapy

Biologics

Mammalian cell culture

Purification

Drug product manufacturing

Clinical stage experience

CDMO oversight

Quality Product (QP) experience

Job description

Our client is a life sciences company focused on advancing a portfolio of gene therapy candidates and neuromuscular and cardiac programs. This remote contract will be 6 months, 15-20 hours per week (possibility to extend).

Scope

Client is a preclinical, IND submission, life science company focused on advancing genetic medicines for neuromuscular and cardiac diseases. Consultant will provide Technical QA oversight with duties including batch record review, deviation review, change control, testing reviews, and CDMO oversight.

Qualifications

Strong preference for direct gene therapy or biologics experience which client defines as mammalian cell culture, purification, and drug product manufacturing with technology platforms to include antibodies, therapeutic proteins, cell / gene therapy. Helpful to have gene therapy process experience with a beginning to end understanding : from starting materials to vial thaw to drug substance to drug product to finished drug product to clinical distribution.

Additionally, clinical stage experience, direct CDMO oversight, and QP experience.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

• ProPharma Group does not accept unsolicited resumes from recruiters / third parties. Please, no phone calls or emails to anyone regarding this posting.