Solid Biosciences

Solid Biosciences is a precision genetic medicine company headquartered in Charlestown, Massachusetts, focusing on advancing innovative gene therapy candidates

Associate Director, MS&T

Location

United States

Posted

49 days ago

Salary

$180K - $220K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

Associate Director, MS&T

Solid Biosciences

• 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.

Job 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

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