Strategic Leader for BioPharmaceutical Development

3 weeks ago

Rockville, Maryland, United States MacroGenics Full time
About the Role

MacroGenics 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.

Key Responsibilities
  • 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.
Requirements
  • 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.
About MacroGenics

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.

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