Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Sr Manager, Associate Biologics CMC Program Leader
Biologics Development and Manufacturing
Minimum of 8 years of industrial experience in Biologics Development.
BS/MS/PhD in relevant science or engineering field
We seek a highly motivated Sr. Manager with demonstrated experience in biologics CMC program leadership to support the implementation of the BioCMC development framework and lead early phase BioCMC program team(s). The qualified candidate will be responsible for working with the BioCMC program leadership group and the line functions of the Biologics Development & Manufacturing organization to build and implement standardized tools and systems that support the BioCMC development framework and the associated Stage-Gate management process. This position is also accountable for leading CMC activities for assigned early stage development programs to deliver on established project goals and timelines.
Responsibilities include, but are not limited to:
Build and implement stage-appropriate standardized tools (project plans, risk registers, dashboards, etc) and approaches to support the BioCMC stage gate development process. Contribute to authorship of guidance documents.
Contribute to the development and implementation of the BioCMC stage gates, milestones, and processes for Biologics development programs.
Work with IT and business operations groups to ensure that all BioCMC stage gates tools and guidance documents are accessible to BioCMC teams.
Ensure that best practices are implemented across BioCMC teams to support harmonization, efficiency, and continuous improvement in the BioCMC development process.
Lead a cross-functional BioCMC matrix team to deliver early stage CMC development project goals within the established timelines
Represent the BioCMC team on Global Project Teams, and CMC technical and program reviews with governance boards and senior management.
Maintain currency with applicable global regulations and industry standards for development of biological products.
Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies, as appropriate.
BSc, MS, or PhD in relevant scientific or engineering discipline
Minimum of 20 years of experience (BSc)/17 years of experience (MS)/ 8 years of experience (PhD) in biotech/pharmaceutical industry with exposure to various stages of biologics development.
Experience in leading CMC development teams/sub-teams.
Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross functional team environment.
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment.
Clear understanding of the process and functional interdependencies required to deliver a biological product to the clinic.
Subject matter expertise in one or more functional areas (cell culture, purification, drug product, analytical).
Strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority.
Highly developed interpersonal, communication and negotiation skills.
Demonstrated ability for critical thinking and innovation.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.