Director, Analytical Sciences

MacroGenics, Inc.•Rockville, MD

17h•$187,700 - $286,300

About The Position

MacroGenics is a leader in the discovery and development of innovative medicines that utilize next generation antibody-based technologies, with a team of 350+ individuals advancing a pipeline of product candidates to treat cancer. The company values its employees and fosters a culture of innovation, open communication, and teamwork. The Director, Analytical Sciences is responsible for leading the development, qualification, and transfer of robust analytical methods for complex biological molecules, including monoclonal antibodies, multi-specifics, and antibody drug conjugates (ADC). This role involves overseeing early-phase and late-phase method development, qualification, transfer to QC, establishing specifications for clinical and commercial products, and defining Critical Quality Attributes (CQAs), Control Strategies, and Product Characterization strategies. This position is a core member of the BioPharmaceutical Development (BPD) leadership team.

Requirements

B.S. in Chemistry, Biochemistry, Chemical Engineering or relevant life science field with a minimum of 20 years experience in biopharm industry
M.S. in relevant fields with a minimum of 15 years of experience in biopharm industry
PhD in relevant fields with a minimum of 10 years of experience in biopharm industry
Demonstrated experience in managing a diverse analytical development function.
Experience in developing & qualifying biochemical, physical and biological test methods for protein-based biotherapeutics. Experience in troubleshooting on method development and qualification.
Experience in concurrently transferring multiple method to Quality Control team in the company or to external laboratories.
Experience in establishing specifications for product release and stability studies, and phase-appropriate analytical testing strategies.
Demonstrated leadership in Critical Quality Attribute (CQA) assessment, and designing and implementing analytical Control Strategy.
Experience in defining strategies for product characterization and comparability studies.
Experience in authoring regulatory dossiers (INDs, BLAs).
6+ years’ experience in team management. Demonstrated capability of effectively managing supervisors and individual contributors, as well as developing and mentoring team members.
Proven track record of leading analytical development activities for protein-based biotherapeutics.
Knowledge of Quality by Design principles, cGMP and CMC requirements for regulatory filing globally, especially in the US and Europe.
Knowledge in product quality attributes of MAb-based molecules, and orthogonality of analytical methods.
Understanding and implementing FDA, EMA, ICH guidelines for release, stability, and characterization assays.
Strong writing and verbal communication skills, and effective communication with interdisciplinary and cross-functional teams.
Capability of working in a fast-paced team environment, achieving on-time delivery of robust methods and test results, and prioritizing work across multiple projects.

Nice To Haves

Knowledge in product quality attributes of a variety of recombinant molecules, including monoclonal antibodies, bispecific antibodies, and antibody drug conjugates.
Knowledge in multi-attribute methods (MAM).
A track record of promoting platform and technology innovation.
Experience in using high-throughput instruments on method development or sample analysis.
Experience in logistic planning and using project management tools (MS Project, SmartSheet).
Author of publications in method development in relevant scientific journals, or presentations at industry conferences.

Responsibilities

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 Product.
Oversee transfer of analytical methods to Quality Control or contract test labs at all stages of clinical development for release and stability testing. Support Quality Control team on method qualification or 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.
Lead in defining strategies and execution of BLA-enabling activities, including product characterization, comparability studies, Critical Quality Attribute (CQA) assessment, design of the analytical Control Strategy.
Author and review technical reports, regulatory dossiers, and address questions from Health Authorities.
Manage sample analysis to support development activities for internal and CDMO programs.
Champion cross-functional communication to align short- and long-term needs within BPD and with other stakeholders. Provide recommendations on strategies and long-term objectives for BPD department.
Manage the performance and development of team members. Cultivate a cohesive, innovative, nimble and productive team environment.
Champion and implement Continuous Improvement on technical and business processes at Analytical Sciences and within BPD. Actively engage in identifying, sharing and adapting best practices cross-functionally.
Present scientific findings at internal and external meetings, and champion scientific journal publications. Represent MacroGenics at industry consortia and conferences.