Associate Director, MS&T in Remote at Solid Biosciences
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Job Description
Associate Director, MS&T – Solid Biosciences
Charlestown, MA (Remote)
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.
Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.
We are seeking an experienced and highly motivated Associate Director to be responsible for providing direct and detailed GMP manufacturing oversight for the company’s gene therapy products at external manufacturing partners. The ideal candidate will be able to apply strong depth of applied manufacturing sciences and technical project management to deliver all manufacturing preparations to meet quality requirements, while coordinating across internal and external stakeholders including Process and Analytical Development, Quality, Regulatory, and CDMO functions.
This role will report to the Senior Director, MS&T and will be remote, requiring up to 25% travel at times.
Key Position Responsibilities
- 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.
Compensation
The base compensation range for this role is: $180,000.00 - $220,000.00
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.
Benefits and Solid Advantages
At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.
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