Director, Formulation and Drug Product Development

Viridian Therapeutics, Inc.; Waltham (MA); On-site; USD 200,000 - 245,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision insurance

100% Paid Parental Leave

401(k) Company Match

Vacation and holidays

Job summary

Viridian Therapeutics, Inc. is seeking a Director of Formulation and Drug Product Development to lead formulation and drug product strategies across our biologics pipeline, with emphasis on monoclonal antibodies.

You will integrate formulation science, stability data, and regulatory expectations into phase-appropriate development paths. The role reports to the Executive Director, Drug Development and is based at our Waltham, MA headquarters.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, or related field with 8+ years of industry experience preferred
• MS with 10+ years of industry experience; or BS with 12+ years of industry experience
• Experience supporting products from early clinical development through late-stage development, process validation, and commercial readiness
• Experience with external CDMOs and managing outsourced development and manufacturing activities
• Strong foundation in protein formulation science, including degradation pathways, stabilization mechanisms, and formulation optimization
• Proficiency with analytical characterization techniques to guide development decisions
• Travel up to 15% as part of the role
• Salary range commensurate with experience

Responsibilities

• Lead formulation development activities for biologic products, including design, excipient selection, and stability strategy development
• Develop overall formulation and drug product development strategies balancing quality, manufacturability, patient needs, and timelines
• Design and oversee formulation development, process development, characterization, and validation studies
• Apply understanding of protein structure and degradation pathways to guide development decisions
• Lead drug product process development activities including fill-finish, scale-up, tech transfer, and validation
• Provide technical leadership for external CDMOs and partners
• Review technical protocols, reports, and development plans
• Contribute to CMC strategy and regulatory submissions
• Assess risks and drive mitigation strategies for formulation and manufacturing challenges
• Maintain awareness of regulatory expectations and industry trends in biologics

Skills

Executive communication

Autonomy

Accountability

Analytical skills

Education

Ph.D. in Pharmaceutical Sciences/related

M.S. in relevant field

B.S. with extensive experience

Tools

Microsoft Office

Job description

At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases, and we are getting closer to achieving this goal every day.

Reporting 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

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.

Salary Range

$200,000—$245,000 USD

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