Celgene Director, Analytical Development, Biologics in Summit, New Jersey
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.
This is a senior analytical role in Biologics Development at Celgene. It carries responsibility for building the attribute sciences capabilities for early and late stage molecules. As a leader in the Analytical Development team, the incumbent is responsible for leading the characterization, attribute criticality assessment, and defining the control strategy for large molecule therapeutics, from candidate nomination through commercial registration - both from the internal Celgene pipeline and from third party collaborations. This individual will be a key member of the Analytical Development leadership team and is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.
Responsibilities include, but are not limited to:
1.Create, define, and lead an attribute sciences team within the analytical development organization to meet the expanding needs of the Celgene Biotherapeutics pipeline.
2.Build the scientific knowledge, capabilities, and strategies in molecular characterization that enable fast to clinic/fast to market product development and commercialization. Maintain current awareness in areas of expertise.
3.Lead the overall scientific, technical and operational efforts within Analytical Development in regards to physicochemical characterizations and analytical methods
4.Establish procedures and protocols that would enable a deeper understanding of the impact of molecular attribute on product safety and efficacy to justify and establish the control strategy
5.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 characterization and qualification reports that support development activities
6.Establish internal capabilities and tools for rapid characterization of product quality to enable upstream, downstream, and formulation development and optimization.
7.Identify and establish partnerships with external vendors to leverage capabilities not available in-house
8.Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support discovery and product development.
9.Maintain currency with applicable global regulations and industry standards for analytical testing and characterization of biological products.
10.Define science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
11.Participate effectively in internal development programs and in external collaborations by representing the analytical development organization as needed
12.Develop the bio-analytical staff to function effectively in cross-functional teams and collaborations.
13.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 bio-analytical activities.
14.Participate in CMO/CRO selection, management and auditing as needed.
15.Interact effectively and transparently with functional leads within Biologics Development, and with other Celgene stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Business Development, Alliance Management, etc.).
16.Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Biologics Development.
Minimum of 15 years industrial experience in Biologics Development.
Ph.D. in relevant science or engineering field
1.Ph.D. in relevant scientific discipline required
2.15 years pharmaceutical bio-analytical experience with exposure to all stages of biologics development
3.Demonstrated track record in product characterization utilizing mass spectrometry and related technologies
4.Direct experience in CMC analytical and regulatory requirements, including development of product specifications and extended analyticalcharacterization, to support early and late stage product development and global commercial registration submissions
5.Solid understanding of how Biopharmaceutical Development integrates with key business partners
6.Proven leadership ability to align, motivate and empower team members
7.The ideal candidate will also have experience in interacting with CROs
8.Demonstrated ability for critical thinking, problem solving and innovation
9.Strong sense of value of investment and ability to develop cost-effective development plans
10.Effective communication, collaboration and negotiation
11.Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment
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.
Director, Analytical Development, Biologics
Location: Summit, NJ, US
Job ID: 16001978