Director, Biologics Commercial Technical Services

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

* The Director, Biologics CTS is responsible for leading all aspects of late stage development and commercialization of Process Development as it relates to Celgene’s biologics product portfolio. * The major responsibilities include the development and oversight of technology development, product comparability and technology transfer at different manufacturing scale facilities (mammalian cell process). * Oversight of API development of 5+ biologics candidates in Research Pipeline. * Require supervision of 2-3 chemical engineers/biochemical engineers * He/She will have a functional leadership role for API development and scale-up in the Biologics Commercial Technical Services (CTS) group. * Functional leadership involvement and responsibility for * Health Authority interactions (i.e. audits, questions and submissions) * CMO selection, auditing, project planning, contracting and management * New Biologics opportunity and technology assessments * Manages development and scale-up activities for manufacturing of biologic products drug substance. * Provide leadership and technical direction to cross-functional teams to assess and maintain process and product comparability across sites and scales and in data intensive process investigations * Contribution and oversight of the CMO process and validation documentation. * Evaluating/Developing new technologies associated with bioreactor operations. Function as independent or large multi-disciplinary teamwork * Lead initiatives to assess and maintain process and product comparability across sites and scales * Identify opportunities for improving process yield and consistency * Support business process improvement initiatives to improve the operation of the biologics manufacturing. * Other key responsibilities include, but are not limited to, the following: * Collaborating with key stake-holders (e.g., different functional groups to drive development of biologics pipeline) * Serves as important liaison to external contacts and licensing partners on CMC activities. * Applies influence and negotiation skills to drive business results

**Prerequisites:** * Ph.D. degree & 9 years of directly related experience * Master’s degree & 13 years of directly related years, and 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. * Major in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline. **Skills/Knowledge Required:** * In depth understanding and application of principles, concepts, practices, unit operations and standards along with an in depth knowledge of biologics proteins manufacturing and corresponding cGMP industry practices. * Technical understanding of the regulatory and compliance requirements of protein therapeutics * Demonstrated ability to function in a collaborative/team oriented environment. * Strong communication, collaboration and team building skills; ability to connect with all levels of the organization * Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation * Good verbal and written communication skills. Sound organizational and time management skills * Experience in cell culture process development and technology transfer and/or knowledge of mammalian cell physiology and metabolism. * Strong background in cGMP biologics manufacturing, Display a strong focus on quality, detail and results. * Project management skills and the ability to influence others without direct authority is a highly desirable characteristic for this position.