Associate Director, MS&T

Job not on LinkedIn

🕒 June 11

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $180k - $220k / year

⏰ Full Time

🟠 Senior

👔 Director

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Solid Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Solid Biosciences is a Charlestown, MA–based precision genetic medicine company focused on developing gene therapies for rare neuromuscular and cardiac diseases. The company advances a portfolio of gene therapy candidates — including SGT-003 for Duchenne muscular dystrophy, SGT-212 for Friedreich’s ataxia, SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), and SGT-601 for TNNT2-mediated dilated cardiomyopathy — and is developing libraries of genetic regulators and delivery-platform technologies to improve gene therapy delivery. Founded with a patient-focused mission and collaborations across science, technology, and care, Solid emphasizes clinical development, manufacturing infrastructure, and partnerships to bring transformative precision genetic medicines to patients with rare genetic diseases.

📋 Description

• 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

• 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

• 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