Celgene Associate Director, Biologics Analytical Development 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 key analytical role in the Biologics Development group at Celgene. It carries responsibility for establishing and implementing appropriate business processes in the Analytical Development organization that is responsible for early and late stage molecules. As a leader in the Analytical Development team, the incumbent is responsible for defining the analytical workstreams and best practices 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 roles and responsibilities, including analytical project leadership, as the Biologics portfolio and organization expands.
Responsibilities include, but are not limited to:
Create, define, and lead cross functional workstreams within the Biologics organization to meet the expanding needs of the Celgene Biotherapeutics pipeline.
Lead the overall scientific, technical and operational efforts within Analytical Development in regards to specifications and phase appropriate analytical method development from candidate nomination to clinical development and commercial manufacture
Participate effectively in internal development programs and in external collaborations by representing the analytical development organization as needed
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
Establish an information management system to capture relevant project data, assay performance, and analytical development information to create and maintain a comprehensive analytical knowledge base.
Establish a framework for phase appropriate method development, specifications, release assays and certification, stability studies, comparability assessments, process analyses and validations to enable clinical advancement and commercial registration of the Biotherapeutics portfolio.
Identify and establish partnerships with external vendors to leverage capabilities not available in-house
Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support product development.
Maintain currency with applicable global regulations and industry standards for analytical testing and characterization of biological products.
Establish processes to enable effective collaboration with CMO/CRO to ensure maximal efficiency and prioritization of programs.
Participate in CMO/CRO selection, management and auditing as needed.
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.).
Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Biologics Development.
Ph.D. in relevant scientific discipline required
10 years pharmaceutical bio-analytical experience with exposure to all stages of biologics development
Demonstrated track record of analytical methods development and product characterization
Direct experience in CMC analytical and regulatory requirements, including development of product specifications to support early and late stage product development and global commercial registration
The ideal candidate will also have experience in interacting with CROs
Effective communication, collaboration and negotiation
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.
Associate Director, Biologics Analytical Development
Location: Summit, NJ, US
Job ID: 17000321