Senior Director, Analytical Development

Description

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Chief Technical Operations Officer, the Senior Director, Analytical Development will play a critical role in the development and characterization of monoclonal antibody drug products, ensuring the quality, safety, and efficacy of our pipeline. The Senior Director, Analytical Development will be responsible for overseeing all aspects of analytical development, from early-stage research to commercial manufacturing.

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):

Strategic Leadership:

• Develop and execute a comprehensive analytical development strategy aligned with the company's overall research and development goals.
• Provide scientific and technical expertise to guide the development and optimization of analytical methods for monoclonal antibodies.
• Lead the identification and implementation of cutting-edge technologies to enhance analytical capabilities.

CMC Program Leadership:

• Lead and manage CMC projects/programs, ensuring project goals and timelines are met.
• Manage budgets and allocate resources effectively to support program objectives.
• Foster collaboration between CMC teams and other departments to drive project success.
• Identify and mitigate risks to ensure program stability and success.

Team Management:

• Build and lead a high-performing team of scientists and technicians, fostering a culture of collaboration and innovation.
• Mentor and develop team members to achieve their full potential.
• Set clear goals and objectives for the team and ensure timely delivery of results.

  

Analytical Method Development and Validation:

• Oversee the development, optimization, and validation of analytical methods for monoclonal antibodies, including but not limited to:
• Purity and impurity analysis (e.g., HPLC, CE-SDS)
• Potency assays (e.g., cell-based assays)
• Characterization assays (e.g., peptide mapping, glycan analysis)
• Functional test methods for combination products (e.g. glide force, ejection time)
• Experience managing or supporting stability programs.
• Ensure compliance with regulatory requirements (e.g., ICH guidelines, CFR 820 standards) and industry standards.
• Establishes and maintains specifications and writes/reviews analytical development protocols and reports.

Regulatory Support:

• Prepare and review regulatory documents (e.g., INDs, BLAs) related to analytical development.
• Represent the company in interactions with regulatory agencies on analytical matters.

Collaboration:

• Establish and maintain relationships with external partners (e.g., CDMOs, CROs, academic institutions) to leverage expertise and resources.
• Collaborate with Viridian Quality Control to ensure effective oversight of our stability programs.
• Stay abreast of scientific advances and emerging technologies in the field of monoclonal antibody analytics.

Requirements

Required Qualifications:

• PhD in Biochemistry, Analytical Chemistry, or a related field
• 15+ years of experience in the pharmaceutical or biotechnology industry, with a proven track record in analytical development of monoclonal antibodies
• Strong leadership and management skills, with the ability to build and motivate high-performing teams
• Demonstrated expertise in various analytical techniques (e.g., HPLC, CE-SDS, mass spectrometry) and a deep understanding of monoclonal antibody characterization
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Demonstrated experience in regulatory interactions and submissions
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• The salary range for this position is commensurate with experience

Preferred Qualifications:

• Experience with large molecules, biological modalities, and combination products
• Familiarity with Quality by Design (QbD) principles
• Experience in technology transfer and scale-up of analytical methods

Viridian offers a comprehensive benefits package including:

· Competitive pay and stock o