Process Sciences (DP) Associate Director

Solid Biosciences•Boston, MA

4d•Hybrid

About The Position

Process Sciences Drug Product Associate Director – Solid Biosciences 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 candidate to lead Drug Product activities within the newly formed Process Sciences Department within Solid Bio’s Technical Operations team. Through your deep product and process understanding you will shape CMC and program strategy and ensure robust control strategies to the benefit of patients worldwide. In this role, you will be a key subject matter expert across one or more areas of drug product sciences including formulation development, primary container development, fill-finish process development, optimization, and scale-up, and Product Validation studies. This is a highly cross-functional role that will work closely with Drug Substance process sciences, MSAT, analytical sciences & QC, device development, supply chain management, Regulatory, and Quality in CMC teams to drive technical and strategic decision-making This role will report to Director – Process Sciences and will be a remote or hybrid position. Up to 15% travel will be required at times.

Requirements

Bachelor’s degree in science, engineering or equivalent with 12+ years of experience working in a related pharmaceutical environment. Advanced degree (MS/PhD) preferred.
Deep knowledge of drug product process development and pharmaceutical manufacturing for biologics and/or Advanced Therapies including Fill‑finish and aseptic processing knowledge, including formulation preparation, sterile filtration, aseptic filling, frozen storage, and handling considerations.
First-hand experience in successfully scaling up and executing drug product manufacturing processes on pilot plant and/or commercial manufacturing scales across all phases of drug development from initial regulatory filings through registration, validation and launch.
Demonstrated experience with multiple aspects of Drug Product manufacturing including drug product formulation, fill/finish processes, clinical in-use studies and product image (container, volume, etc.) design.
Strong understanding of critical quality attributes (CQAs), critical process parameters (CPPs), and critical material attributes (CMAs) for drug product processes.
Experience supporting regulatory submissions (IND, BLA/MAA) with respect to drug product, formulation, CCS, and validation sections.
Knowledge and experience working in accordance with cGMP, GDP, GCP, and ICH guidelines including Quality by Design (QbD) and risk‑based development principles (ICH Q8(QR), Q9, Q10).

Nice To Haves

Proven ability to work effectively across Technical Operations, Drug Substance, MSAT, Analytical Sciences, Quality, Regulatory, Device Development, and Supply Chain.
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.
Experience engaging with external suppliers and partners including contract manufacturing organizations.
Expertise in comparability assessments, post‑change risk evaluations, and lifecycle management.
High attention to detail with the ability to operate effectively at both strategic and execution levels.
Scientific curiosity paired with pragmatic decision‑making.

Responsibilities

Serve as a liaison to CMC teams to shepherd new pipeline products from development into manufacturing providing technical expertise across formulation, container/closure systems, fill‑finish, scale‑up, and product validation for gene therapy programs.
Partner with Technical Operations and CMC leadership as a Drug Product SME to define integrated strategies that support regulatory alignment, patient needs, and long‑term commercial readiness.
Lead the implementation of phase appropriate drug product process control strategies by following the FDA guidance and QbD to enable effective validation strategies at external CDMOs.
Ensure readiness for clinical and commercial manufacturing through risk‑based process understanding, comparability, and lifecycle management.
Partner with Analytical Development to analyze, and interpret drug product characterization, stability, and release data while defining CQAs for Drug product processes.
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 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.
Design and execute product validation studies, (Ex: Time out of Refrigeration, container closure integrity (CCI), and leachable and extractable studies).
Lead selection and development of container closure systems that support drug product and delivery requirements while ensuring quality, stability, manufacturability, and scalability across clinical and commercial supply.
Lead or support container closure integrity (CCI) testing across development, validation, and commercial manufacturing in alignment with regulatory expectations.
Drive selection and integration of drug delivery devices in collaboration with clinical and regulatory functions.
Design and execute container closure and delivery system qualification and in‑use compatibility studies, including evaluation of material interactions, adsorption, and extractables/leachables across manufacturing, storage, handling, and administration conditions.
Lead phase‑appropriate drug product formulation development, characterization, and design space definition through risk‑based screening, optimization, and robustness studies.
Characterize and evaluate formulations by assessing critical quality attributes (e.g., potency, purity, stability, particulates, aggregation) under relevant manufacturing, storage, and in‑use conditions.
Assess formulation performance and stability across manufacturing operations and lifecycle stages, including preparation, sterile filtration, filling, freezing/thawing, storage, and stress conditions.
Support lifecycle management activities, including formulation changes, comparability assessments, and continuous improvement initiatives.
Lead or significantly contribute to Drug Product sections of regulatory submissions (INDs, BLAs/MAAs), health authority responses, and inspection readiness activities related to drug product.
Author and review regulatory submissions: IND/IMPD, briefing books and BLA.
Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.

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
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)