Director/Sr. Director, Analytical Sciences

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 BioPharmaceutical Development (BPD) department.

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 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.

Qualifications:

Director, Analytical Sciences

Education, Certifications & Experience

• 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

• PhD. 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.

Sr. Director, Analytical Sciences

Education, Certifications & Experience

• 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

• PhD. 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. Demonstrated capability of effectively managing supervisors and individual contributors, as well as developing and mentoring team members.

Knowledge, Skills and Abilities

• Proven track record of leading analytical development activities for protein-based biotherapeutics.
• Knowledge of Quality by Design principles, Process Analytical Technologies (PAT), cGMP, and CMC requirements for regulatory filings globally, especially in the US and Europe.
• Strong writing and verbal communication skills, and effectiveness in communicating with interdisciplinary and cross-functional teams.
• Understanding of FDA, EMA, ICH guidelines associated with release, stability, and characterization assays.
• 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.

Preferred Qualifications

• Experience in a variety of recombinant molecules, including monoclonal antibodies, bispecific antibodies and antibody drug conjugates.
• Experience in defining strategy for late-stage biologics drug development.
• A track record of promoting platform and technology development.
• A recognized technical expert in method development and innovation for biotherapeutics.
• Author of publications in method development in relevant scientific journals, or presentations at industry conferences.

Supervisory Responsibilities:

Yes

Additional Information

The annual rate of pay for this position ranges from $184,500 - $281,300 (Director, Analytical Sciences) and $207,400 - $316,300 (Sr. Director, Analytical Sciences). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.