Director, Biologics MS&T

Summit, NJ, US
Nov 05, 2018
Required Education
Position Type
Full time
Other Locations:US- NJ- Summit West


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.


Eligible for Employee Referral Program

Director, Biologics Drug Substance - Upstream MS&T


Senior Director


Biologics Development and Manufacturing

Minimum of 12 years industrial experience in Biologics Development.

Ph.D. in relevant science field

This senior role in Biologics Development and Manufacturing at Celgene will define strategy for Drug Substance process transfer to commercial scale, process validation at scale and contribute directly to global licensure applications, commercialization and post-commercial support of biologics drug substance. The role also carries responsibility for providing oversight for the transition of programs entering the commercial space following clinical development. This individual will be a key member of the Manufacturing Sciences and Technology Team and is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.

Responsibilities include, but are not limited to:

Own and lead Process Validation activities to enable seamless and robust tech transfer to commercial manufacturing sites, and support commercial drug substance manufacturing operations for all biologic molecules. Develop and support the transfer of robust DS processes to manufacturing sites; provide in-plant support as appropriate. Troubleshoot issues with drug substance processing technologies and equipment; transfer technology to commercial manufacturing sites; conduct risk assessment for drug substance operations and propose / lead and support technical evaluation of Change Notification, implement appropriate CAPA; identify and implement operational opportunities for current and new sterile operations. Campaign monitoring and support, performance analysis and interpretation, campaign summary report authoring, and routine presentations to cross-functional teams and management Process and product monitoring, master data and documentation management, compliance to Celgene quality systems, and other readiness operational support activities. Share responsibility for the group's scientific and technical standards, critical review of documentation and reports, and setting control strategy to support commercial life cycle maintenance. Deliver timely data and process knowledge needed to meet Celgene project milestones and associated regulatory requirements. This includes the design of protocols, execution, reporting and approval of qualification and validation reports that support life cycle maintenance Identify and establish partnerships with external vendors to leverage capabilities not available in-house. Maintain currency with applicable global regulations and industry standards. Respond to Health Authority queries regarding queries/control strategy as appropriate. Participate effectively in internal development programs and in external collaborations by representing the manufacturing organization as needed Develop the MSAT staff to function effectively in cross-functional teams and collaborations. Maintain a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs. Budget and track external expenses for CMO/CRO DS related activities. Participate in CMO/CRO selection, management and auditing as needed. Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Biologics Development.

Skills/Knowledge Required:

Degree in Chemical Engineering, Pharmaceutical Sciences or relevant scientific discipline with experience in DS process development, and registration of therapeutic protein products is required. Experience requirements: PhD > 12 years; or M.S. > 15 years; or B.S. > 20 years of relevant experience. Demonstrated prior record of successful DS development, supporting clinical/commercial programs for recombinant protein products, including authoring of regulatory submissions globally. Experienced in planning and executing late stage robustness studies and control strategy is a requirement. Experience in authoring relevant sections of BLAs is highly desired. Must have significant prior experience in working with CMOs/CROs. Expertise in cell culture process development (fed batch and perfusion), process characterization and validation, scale-up/scale-down principles of cell culture or fermentation processes, primary clarification, continuous centrifugation. Demonstrated ability for critical thinking, problem solving and innovation. Must have a good understanding of GMP manufacturing and GMP compliance. Working knowledge of current US, EU, and global Regulations, ICH guidance and relevant standards and quality system requirements for biological drug substance manufacturing. Strong working knowledge of current Regulatory guidance on late stage and continued process verification requirements is a plus Strong communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate. Proven ability to work effectively within the department and with cross-functional stakeholders. Proven leadership ability to align, motivate and empower team members. Ability to work independently, strong written and communication skills and experience working in a matrix organization. Strong sense of value of investment and ability to develop cost-effective development plans. Up to 30% travel required

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.