Associate Director, Quality Control

Job Description

Job Title:

Associate Director, Quality Control

Reports to (title):

Head of Analytical Sciences

Solid Summary:

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.

Position Summary:

We are seeking an Associate Director, Quality Control to strengthen a fast-growing, and well-funded company working to advance novel genetic therapies for neuromuscular and cardiac diseases. The successful candidate will be responsible for leading and managing Quality Control activities for 2 of Solid’s (pre)clinical programs at CDMOs and external testing labs in support of product manufacturing, release, characterization, and stability of AAV Gene Therapy products. The position will interface closely with the greater Tech Ops and Quality Assurance teams providing strategic and tactical support for our growing clinical products portfolio and the eventual launch of a commercial product. The ideal candidate has experience in preparation and execution of Quality Control activities for registrational stage programs (PPQ/BLA readiness), a solid technical background (AD) and hands-on experience leading and supporting assay qualification/validation of analytical methods, tech transfer, comparability studies, quality systems, regulatory filings and CMC activities.

Key Duties & Accountabilities:

Lead and oversight of Quality Control activities at CDMOs and external testing labs in support of product release on accelerated timelines.

Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories and the review and approval of Quality Control data and CoA/CoTs.

Ensures the timely execution of release tests by external laboratories to facilitate batch disposition under accelerated timelines

Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments.

Manage specifications for excipients, drug substances and drug products.

Coordinate the shipment of cGMP and other quality-controlled samples from/to CDMOs and contract laboratories.

Track and statistically evaluate internal and external analytical data trends.

Support the continues improvement of Quality Control systems such as product specifications, product shelf-life/expiry, reference standard program, stability program, etc.

Co-lead method transfer, qualification and/or validation, working closely with Analytical Development

Review SOPs, protocols, reports, impact assessments and root cause analyses.

Interact effectively with cross functional teams and solve testing related issue.

Provide Quality Control lead and support with regulatory submissions (IND/BLA)

Core Competencies Required:

Inclusive

Empowered

Collaborative

Resilient

Focused

Knowledge: Education, Experience, & Skills:

BS/MS with 10+ years or Ph.D. with 5 years relevant industry experience in managing Quality Control Labs with a degree in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific discipline.

Experience working in a Quality Control lab environment with expert knowledge of international (e.g. ICH) and national quality regulations and guidelines (USP/EP) related to product testing, analytical and stability requirements, validation of analytical methods.

Experience managing CDMOs and Contract Test Labs activities

Experience authoring and reviewing CMC sections of Regulatory Filings

Excellent communication skills and ability to build key networks and business relationships across all levels of the business

Travel Commitment:

Anticipate <15%

Occasional travel for on-site visits to external suppliers and company meetings

Role Location

(HQ, Hybrid, Remote, NC, etc.)

HQ, Hybrid, Remote (based on candidate location)

Full-time

Hybrid remote