Job Description
Job Description
Job Title:
Associate Director, Upstream
Reports to (title):
Director – Process Sciences
Solid Summary:
Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, SGT-212, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.
Position Summary:
SolidBio is seeking an experienced and highly motivated Associate Director, Upstream to be responsible for leading the newly formed Upstream Process Sciences group within Solid Bio’s Technical Operations team. The ideal candidate will be able to apply strong depth of applied manufacturing sciences and technical project management to deliver robust process control strategies for the company’s pipeline of assets while coordinating across internal and external stakeholders including Process and Analytical Development, Quality, Regulatory, and CDMO functions.
Key Duties & Accountabilities:
- Serve as a liaison to CMC teams to shepherd new pipeline products from development into manufacturing. This includes collaborating with upstream process engineers and development scientists to adapt pipeline assets to Solid’s next generation upstream manufacturing platform and transfer robust processes to commercial and third-party manufacturing operations.
- Lead the implementation of phase appropriate upstream process control strategies by following the FDA guidance and QbD to enable effective validation strategies at external CDMOs.
- Provide technical expertise to pre-validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
- Provide technical expertise for establishing qualified scale down models of the upstream process to enable process characterization.
- Provide technical expertise for establishing critical process parameters and a process validation strategy that supports product licensure including design and oversight of process characterization activities ensuring robust operational range finding studies and establishment of appropriate NORs and PARs for in process controls.
- Support Tech Ops team in optimizing 2nd generation upstream processes targeting reduced COGs and improved manufacturability, timelines, and development plans in collaboration with broader global team including project management, MS&T, Process Development, Analytical Development/QC, QA, and regulatory members.
- Integrate cross-functional and/or external information and apply technical knowledge to data-driven decision-making
- Collaborate with a cross-functional team to support new product commercialization, process improvements, and technology transfers between internal and external manufacturing sites.
- Assist in the technical aspects of the company’s regulatory filings, including process validation for BLA filings.
Core Competencies Required:
- Demonstrated experience managing projects in the pharmaceutical industry.
- Deep knowledge of upstream process development and pharmaceutical manufacturing for biologics
- Experience developing robust control strategies enabling reliable validated biomanufacturing process
- Experience engaging with external suppliers and partners.
- Knowledge and experience working in accordance with cGMP, GDP, GCP, and ICH guidelines
- 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.
Knowledge: Education, Experience, & Skills:
Bachelor’s degree in science, engineering or equivalent with 12+ years of experience working in a related pharmaceutical environment. Advanced degree (MS/PhD) preferred.
Preferred Skills:
- Strong analytical skills
- Strong oral and written communications skills
- Ability to work in new/unstructured environments
- Experience working with contract manufacturing organizations
Travel Commitment:
Up to 15% travel will be required at times.
Role Location
(HQ, Hybrid, Remote, NC, etc.)
Remote or Hybrid