DescriptionReporting to the Executive Director, Drug Development, the Director, Formulation and Drug Product Development will provide scientific and technical leadership for formulation and drug product development activities across Viridian's biologics pipeline. This individual will be responsible for developing and advancing formulation strategies, drug product processes, and manufacturing approaches from early development through commercialization, with a focus on monoclonal antibodies and other protein therapeutics. The role requires the ability to integrate formulation science, drug product process development, stability data, product quality understanding, and regulatory expectations into phase-appropriate development strategies.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):- Lead formulation development activities for biologic products, including formulation design, excipient selection, stability strategy development, and support of clinical and commercial dosage forms
- Develop scientifically sound formulation and drug product development strategies that balance product quality, manufacturability, patient needs, regulatory expectations, and program timelines
- Design, oversee, and interpret formulation development, process development, characterization, and validation studies using risk-based and data-driven approaches
- Apply a strong understanding of protein structure, degradation pathways, formulation mechanisms, and product quality attributes to guide development decisions and address technical challenges
- Utilize analytical data and product characterization results to investigate stability trends, define formulation risks, support root-cause analyses, and enable informed decision-making
- Lead drug product process development activities, including fill-finish process development, scale-up, technology transfer, process characterization, and process validation
- Provide technical leadership for external CDMOs and manufacturing partners supporting formulation development, drug product development, technology transfer, and commercial readiness activities
- Review and approve technical protocols, reports, manufacturing documentation, investigations, change controls, and development plans
- Serve as the drug product development representative on cross-functional project teams and contribute to overall CMC strategy and program execution
- Author and review drug product and formulation sections of regulatory submissions, health authority responses, and other technical documents
- Assess technical risks, develop mitigation strategies, and drive resolution of formulation, manufacturing, and product quality challenges
- Maintain awareness of emerging technologies, industry trends, and regulatory expectations relevant to biologics formulation and drug product development
Qualifications:- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, or a related scientific discipline with 8+ years of relevant industry experience strongly preferred; or
- M.S. with 10+ years of relevant industry experience; or
- B.S. with 12+ years of relevant industry experience
- Demonstrated experience supporting products from early clinical development through late-stage development, process validation, and commercial readiness
- Experience working with external CDMOs and managing outsourced development and manufacturing activities
- Deep understanding of protein formulation science, including degradation pathways, stabilization mechanisms, excipient selection, and formulation optimization
- Strong foundation in analytical characterization techniques and the ability to use analytical data to guide formulation and process development decisions
- Demonstrated expertise in experimental design, data analysis, interpretation of complex datasets, and application of scientific principles to solve technical challenges
- Experience with high-concentration protein formulations, lyophilized products, or other challenging biologic dosage forms
- Experience supporting combination products, including prefilled syringes and autoinjector presentations
- Strong written, verbal, and executive-level communication skills; able to operate with significant autonomy, sound judgment, and high accountability in a fast-paced matrix environment
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 15%
- The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
- Competitive pay and stock options for all employees
- Medical, dental, and vision insurance
- 100% Paid Parental Leave
- Short- and long-term disability coverage
- Life, Travel and AD&D
- 401(k) Company Match with immediate company vest
- Employee Stock Purchase plan
- Generous vacation plan and paid company holiday shutdowns
- Various fertility, mental, financial, and proactive physical health programs
