Celgene Sr Scientist, Analytical Dev - Biologics in Cambridge, Massachusetts
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.
Senior Scientist, Analytical Development, BiologicsSummit, NJ
Associate Director, Analytical Development
Biologics Development and Manufacturing
PhD in a relevant science or engineering field
Minimum of 4 years of industry experience focused on Biologics Development
This is a key role in Biologics Analytical Development at Celgene. The role carries responsibility for defining and implementing analytical strategy for late-stage molecules to enable successful regulatory submissions. The incumbent will be responsible for independently managing analytical development aspects for assigned projects, including but not limited to control strategy, comparability, and analytical tech transfer. The individual is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.
Define science-driven, phase-appropriate, and risk-based analytical development strategies to support late-stage biologics projects, including the development, vetting, and implementation of a comprehensive analytical strategy to prepare late-stage molecules for commercial license applications
Participate effectively as a key member of Biologics CMC teams and through external partner collaborations by representing the Analytical Development organization
Accountable for delivery of timely data to build product and process knowledge needed to make strategic decisions and to meet Celgene project milestones and associated regulatory requirements. This includes the design, review, and approval of protocols and overseeing of study execution and data generation.
Establish and transfer analytical methods at contract testing laboratories worldwide
Guide development, optimization, and validation of analytical methods both internally and at contract testing laboratories
Independently manage analytical development-related operations and communications with external manufacturing sites and contract testing laboratories to advance analytical development activities
Review analytical data for completeness and correctness and initiate or support investigations
Write formal reports in support of regulatory filings and appropriate responses to questions from regulatory authorities
Interact effectively and transparently with functional leads within the Biologics Development & Manufacturing department and with other Celgene stakeholders in Quality, Regulatory CMC, and Project Leadership
Timely communication of progress and escalation and management of risks
Share responsibility for the department’s scientific and technical standards and critical review of documentation
Maintain currency with applicable global regulations and industry standards for analytical testing and characterization of recombinant protein products
PhD in relevant scientific discipline
At least 4 years of biopharmaceutical industry experience, with focus on analytical development of glycoprotein and other protein-based therapeutics
Demonstrated expertise with physicochemical methods for monoclonal antibodies, fusion proteins, and other biologics.
Capable of troubleshooting method issues as well as defining and managing development and qualification/validation studies for HPLC, capillary electrophoresis, IEX, and SEC methods.
Experience in working with contract laboratories for method development, qualification, validation, and transfer
Experience with contributions to CMC regulatory submissions and/or response to questions
Experience with implementation of enhanced or new release methods for late-stage molecules
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment
Strong problem-solving skills and demonstrated ability for critical and creative thinking
Excellent grammar and communication skills, both oral and written
Proven leadership ability to align and motivate stakeholders and coworkers
Solid understanding of how biopharmaceutical development integrates with key business partners
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.