The Vice President, BioPharmaceutical Development is a strategic leader responsible for oversight of Cell Line Development, Cell Culture Sciences, Purification Sciences, Analytical Sciences and Drug Product Sciences.  This individual will drive early and late stage development and optimization of our antibody, antibody drug conjugates, and multi-specific protein molecules, as well as late stage process characterization and validation. As a key member of our leadership team, this role will establish both short-term and long-term strategic visions to establish platforms and integrate new technology to deliver processes, analytics, and formulations. This individual will be responsible for the technical content of our IND and BLA submissions.  He/she will work closely with research, manufacturing, validation, quality and regulatory functions to support development of molecules leading to commercialization. This Vice President will also be responsible for championing processes that focus on the leadership and development of employees who work to support these activities.

Responsibilities and Job Duties

• Lead early stage pipeline programs, including process development, scale-up, toxicology material production, technology transfer, clinical material manufacturing support, analytics, formulations and IND submissions, to support development of molecules leading to commercialization.
• Develop and implement strategic goals and lead the efforts for late stage program strategies toward commercialization, including the design, coordination, and execution of process and product characterization and small and large scale validation studies.
• Establish strategies for determining critical quality attributes and control strategies for our products and processes. Ensure understanding of strategies and drive the development of action plans to execute strategies.
• Responsible for the department’s annual budget and quarterly forecasting processes. Ensure sound management of head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.
• Create a high-performing team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.
• Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.
• Ensure all development activities relating to drug substance and drug product are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.
• Recruit, motivate, retain and develop key employees. Build and sustain employee engagement by creating an environment where individuals and teams can excel. Establish departmental and individual goals and objectives in alignment with corporate goals and priorities. Identify performance improvement targets and metrics.
• Review and edit content of development sections of IND, BLA, and other regulatory documents such as protocols and technical reports in collaboration with the development, quality, and regulatory groups to support regulatory filings.
• Present scientific findings at internal and external meetings and champion scientific journal publications. Represent MacroGenics at meetings with collaborators
• Champion and implement business processes for continuous improvements and support continuous improvement culture & mindset within the organization. Actively engage in the identification, sharing and adaptation of best practices cross-functionally
• Effectively and transparently manage multiple, at times conflicting priorities, and proactively seek creative yet viable solutions to resolve such conflicts.

Qualifications

Education & Experience

• PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, life sciences or equivalent amount of experience and a minimum of 15 years of biotech industrial experience working with cell culture, purification, analytical, and/or formulation development
• 5 years of experience managing one or more of the development functions in addition to cross-functional departmental experience through project management, leadership team participation , or the equivalent
• At least 8 years of direct people management experience including coaching and developing a team and providing motivation to accomplish goals and objectives
• Experience in managing budgets, project timelines, and resources to accomplish objectives
• Late stage experience, including process and product characterization, validation and commercialization 

Knowledge, Skills and Abilities

• Specific knowledge and in-depth understanding of process and product development as evidenced by a track record of significant contributions to successful IND and BLA submissions
• Solid understanding of current FDA and ICH guidelines to meet regulatory expectations
• Excellent communication skills, both verbal and written, and the ability to influence and interface effectively with internal and external stakeholders
• Demonstrated ability to think strategically
• Ability to think critically and solve problems and possess a quick and analytical mind
• Strong understanding of CMC functions
• Ability to collaborate with and influence other functional areas such as Manufacturing, Validation and Regulatory Affairs
• Ability to support and effectively multi-task different and complex assignments and responsibilities
• Ability to manage, train and mentor staff
• Strong presentation and writing skills to communicate effectively internally and externally
• Ability to lead cross-functional teams, be collaborative, and represent teams at a variety of forums               

Preferred Qualifications

5 years of previous experience overseeing a BioPharmaceutical Development organization

Supervisory Responsibilities

Director/Senior Directors of Cell Line Development, Cell Culture Sciences, Purification Sciences, Analytical Sciences, and Drug Product Sciences

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 [email protected] or call (301) 354-3566 and/or 711 for TTD/TTY service.