Associate Director, MS&T

Solid Biosciences

Associate Director overseeing GMP manufacturing operations for gene therapies at Solid Biosciences. Requires significant expertise in pharmaceutical manufacturing and project management with remote work flexibility.

Posted 6/12/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $180,000 - $220,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Partner with the Company Team including Manufacturing, Quality, AD/QC, Regulatory, and PD as a manufacturing SME for our clinical manufacturing processes and provide direct Person-in-Plant on-site support during, minimally, all critical cell culture, purification, and drug product unit operations at CMO production locations.
Drive GMP Compliance and evaluate all aspects of ongoing production and understand when to intervene on company’s behalf and when to escalate more significant issues for resolution.
Work in close collaboration with the CDMO and internal teams to support manufacturing investigations and change controls.
Provide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plans.
Review and/or approve CDMO manufacturing documentation including manufacturing bill of materials, production master batch records, and executed production record review.
Communicate routine production manufacturing status to company stakeholders and assist as necessary with process data retrieval, processing, analysis, through written, verbal, and presentation at various company meeting forums.
Author key technical documentation supporting manufacturing activities including technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing process and controls.
Author supporting documentation for relevant CMC manufacturing content of various regulatory submissions as needed.

Requirements

What you’ll need

BS in science, engineering or equivalent with 10+ years of experience working in a related pharmaceutical environment
OR advanced degree (MS/PhD) with 8+ years of experience
Demonstrated experience managing projects in the pharmaceutical industry
Knowledge and experience working in accordance with cGMP, GDP, GCP, and ICH guidelines
Experience engaging with external suppliers and partners, including CDMOs
General knowledge of process development and pharmaceutical manufacturing for biologics including cell culture, purification, and/or fill/finish operations
Strong interpersonal flexibility with ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals
Excellent communication skills, both oral and written, which may include planning and execution of meetings and presentations
Ability to multitask and handle multiple competing priorities and projects at once in a changing and fast-paced environment
Strong analytical skills, strong oral and written communications skills, and the ability to work in new/unstructured environments.

Benefits

Comp & perks

Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
12 Observed Holidays and a winter shut down
15-day PTO Policy and a 40-hour rollover YoY
40-hour Sick Policy
8 Hour Floating Holiday

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GMP CompliancecGMPGDPGCPICH guidelinescell culturepurificationfill/finish operationsmanufacturing documentationtechnical risk assessments

Soft Skills

interpersonal flexibilityexcellent communication skillsmultitaskinganalytical skillsadaptabilityteam collaborationproject managementproblem-solvingpresentation skillswritten communication