Job Details
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.Our team of350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies 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. MacroGenics' 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.Summary of PositionThe 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 DutiesLead 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 collaboratorsChampion 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-functionallyEffectively and transparently manage multiple, at times conflicting priorities, and proactively seek creative yet viable solutions to resolve such conflicts.QualificationsEducation & ExperiencePhD 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 development5 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 equivalentAt least 8 years of direct people management experience including coaching and developing a team and providing motivation to accomplish goals and objectivesExperience in managing budgets, project timelines, and resources to accomplish objectivesLate stage experience, including process and product characterization, validation and commercializationKnowledge, Skills and AbilitiesSpecific knowledge and in-depth understanding of process and product development as evidenced by a track record of significant contributions to successful IND and BLA submissionsSolid understanding of current FDA and ICH guidelines to meet regulatory expectationsExcellent communication skills, both verbal and written, and the ability to influence and interface effectively with internal and external stakeholdersDemonstrated ability to think strategicallyAbility to think critically and solve problems and possess a quick and analytical mindStrong understanding of CMC functionsAbility to collaborate with and influence other functional areas such as Manufacturing, Validation and Regulatory AffairsAbility to support and effectively multi-task different and complex assignments and responsibilitiesAbility to manage, train and mentor staffStrong presentation and writing skills to communicate effectively internally and externallyAbility to lead cross-functional teams, be collaborative, and represent teams at a variety of forumsPreferred Qualifications5 years of previous experience overseeing a BioPharmaceutical Development organizationSupervisory ResponsibilitiesDirector/Senior Directors of Cell Line Development, Cell Culture Sciences, Purification Sciences, Analytical Sciences, and Drug Product SciencesStatementMacroGenics 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 ...@macrogenics.com or call (301) ###-#### and/or 711 for TTD/TTY service.Equal Opportunity Employer/Veterans/DisabledWe do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.