Associate Director, MS&T

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🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $180k - $220k / year

⏰ Full Time

🟠 Senior

👔 Director

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Solid Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, such as Duchenne muscular dystrophy and Friedreich’s ataxia. Founded by individuals directly impacted by these conditions, Solid aims to improve the lives of patients through innovative treatments and technologies. The company collaborates with experts in science and healthcare to develop therapies that address significant unmet medical needs in rare 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