Sr Director/Executive Director, Analytical Development and Quality Control

Jade Biosciences; United States; Remote; USD 255,000 - 300,000; Full time

Job summary

An innovative firm is seeking a strategic and technical leader for the role of Sr/Executive Director of Analytical Development and Quality Control. This pivotal position involves overseeing the development of analytical methods for biologics, ensuring compliance with GMP standards, and leading cross-functional collaborations. The ideal candidate will have extensive hands-on experience in analytical drug development, with a strong focus on biologics, and a proven track record of executive leadership. Join a forward-thinking organization dedicated to addressing critical unmet needs in autoimmune diseases and make a significant impact in the field.

Qualifications

• 12+ years of experience in analytical development for Sr Director role.
• 15+ years of experience in analytical development for Executive Director role.

Responsibilities

• Manage development of analytical methods for biologics testing.
• Lead preparation of documentation for regulatory submissions.
• Collaborate with teams to support formulation development.

Skills

Analytical drug development

GMP requirements

Biological molecular post-translational modifications

Product characterization

Analytical troubleshooting

Statistical methodologies

Executive leadership

Collaboration skills

Education

Ph.D. in Analytical Chemistry

Ph.D. in Pharmaceutical Sciences

Job description

Sr Director/Executive Director, Analytical Development and Quality Control

Jade Biosciences is focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead asset, JADE-001, targets the anti-A PRoliferation-Inducing Ligand (APRIL) pathway for immunoglobulin A (IgA) nephropathy, with Investigational New Drug Application-enabling studies underway and initiation of a first-in-human trial expected in the second half of 2025. Jade’s pipeline also includes two undisclosed optimized antibody discovery programs, JADE-002 and JADE-003, currently in preclinical development.

Role Overview

We are seeking a strategic, technical and highly motivated Sr/Executive Director of Analytical Development and QC to join our dynamic team. The successful candidate will possess extensive, hands-on analytical drug development experience, a technical understanding biological molecular post-translational modifications and product characterization as well as a deep understanding of GMP requirements for early to late-stage quality control for biologics supporting successful regulatory submissions. The ideal candidate will have an understanding of and proven experience in developing physicochemical, product related, potency (including cell-based) and biophysical characterization methods.

Key Responsibilities

Analytical Development:

• Direct and manage the development and troubleshooting of early-stage and late-stage analytical methods for biologics release and stability testing.
• Identify suitable state-of-the-art characterization methods required to support process development and product characterization.
• Contribute to the development of the quality target product profile (QTPP) based on an understanding of the biological molecule critical quality attributes (CQAs) and intended mode of action (MoA).

Quality Control:

• Direct and manage qualification and validation of robust method analytical methods for product release and stability testing.
• Oversee method transfer and design transfer protocols.
• Implement phase-appropriate quality control procedures in accordance with GMP and regulatory requirements.
• Develop phase-appropriate drug substance and drug product specifications in line with regulatory requirements and product understanding.

Product Development:

• Collaborate with cross-functional teams to support formulation development.
• Develop and execute analytical comparability testing to support process, formulation and container closure changes.
• Employ product understanding and statistical methodologies to determine appropriate comparability acceptance criteria.
• Establish reference standards qualification and requalification procedures.
• Establish stability programs for drug substance and drug product.

Regulatory:

• Lead the preparation and maintenance of comprehensive documentation in support of regulatory submissions and audits.

Qualifications

• Sr Director: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 12+ years of extensive experience in analytical development and quality control with a focus on biologics.
• Executive Director: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 15+ years of extensive experience in analytical development and quality control with a focus on biologics.
• Proven executive leadership in analytical development and qualification of physicochemical and potency methods.
• Expertise in analytical troubleshooting.
• Demonstrated success in managing late-stage analytical method validation activities.
• Exceptional strategic vision, problem-solving skills, and leadership capabilities.
• Strong executive communication and collaboration skills.

Position Location

This is a remote role; periodic travel to team and company events is required.

The anticipated salary range for candidates for this role at the Sr Director level is $255,000 – $280,000 and at the Executive Director level is $280-$300,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.