Director​/Sr. Director, Analytical Sciences

Macro Genics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. Macro Genics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

The Director/Senior Director, Analytical Sciences is responsible for leading development, qualification and transfer of robust analytical methods for complex biological molecules, including monoclonal antibodies, multi-specific, antibody drug conjugates (ADC). This role will oversee early-phase and late-phase method development, qualification, transfer to QC, establish specifications for clinical & commercial products, and define Critical Quality Attributes (CQAs), Control Strategies, and Product Characterization strategies.

This position will be a core member of the leadership team of Bio Pharmaceutical Development (BPD) department.

• Manage a team of scientists and associates on developing and qualifying robust analytical methods, including physio-chemical, potency, residual, and product characterization assays.
• Provide technical and strategic leadership on developing analytical methods for release and characterization of Drug Substance and Drug Products.
• Oversee transfer of analytical methods to Quality Control at all stages of clinical development for release and stability testing. Support Quality Control team on method validation as needed.
• Lead and coordinate with CMC and regulatory teams to establish specifications for release and stability of Drug Substance and Drug Product, in order to support IND-enabling studies and late-stage development.
• Participate and lead BLA-enabling activities, including product characterization, comparability studies, CQA assessment, design of the analytical Control Strategy.
• Author and review technical reports, regulatory submissions, and address questions from Health Authorities.
• Manage sample analysis to support development activities for internal and CDMO projects.
• As part of BPD Leadership team, champion cross-functional communication to align short- and long-term needs within BPD and other stakeholder departments. Provide recommendations on strategic plans and long-term objectives for BPD department.
• Manage the performance and development of team members. Cultivate a cohesive, innovative, nimble and productive team environment.

• B.S. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 15 years of related experience

OR

• M.S. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 12 years of related experience

OR

• Ph.D. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 10 years of related experience
• Experience in developing and qualifying biochemical, biophysical and biological test methods for protein-based biotherapeutics
• Experience in successful transfer of methods to Quality Control within the company or to external collaborators
• Experience in establishing specifications for product release and stability studies, and defining phase-appropriate test strategies.
• Experience in authoring regulatory filings (INDs, BLAs), and authoring and implementing Control Strategy
• 8+ years' experience in team management. Demonstrated capability of effectively managing supervisors and individual contributors, as well as developing and mentoring team members.

• B.S. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 20 years of related experience

OR

• M.S. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 17 years of related experience

OR

• Ph.D. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 15 years of related experience
• Experience in developing & qualifying biochemical, biophysical and biological test methods for protein-based biotherapeutics
• Experience in the successful transfer of methods to Quality Control within the company or to external collaborators
• Experience in establishing specifications for product release and stability studies, and phase-appropriate test strategies.
• Experience in authoring regulatory filings (INDs, BLAs), and authoring and implementing Control Strategy
• 8+ years' experience in team management.…