Senior Principal Scientist, Analytical Development - Biologics

Req #: 1803423
Location: Cambridge, Massachusetts, United States
Job Category: Technical Development
Work Location: 200 Cambridge Park Drive 02140
Organization: Chemistry
Employee Status: Full-time
Job Type: Regular

POSITION
Senior Principal Scientist, Analytical Development - Biologics
SUPERVISOR
Associate Director, Analytical Development - Biologics
DEPARTMENT
Biologics Development and Manufacturing
PREREQUISITES
PhD in a relevant science or engineering field
Minimum of 10 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 all analytical development aspects for assigned projects. The individual is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.

Responsibilities Include:

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 Mentor junior staff and establishing laboratory capability to support product-specific characterization and method lifecycle management. Contribute to development of department business processes and guidelines for product development 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. Guide development, optimization, and validation of analytical methods both internally and at contract testing laboratories. Oversee method investigations and continuous improvement. Oversee late-stage analytical development-related operations and communications with external manufacturing sites and contract testing laboratories to advance analytical development activities Contribute to 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

Skills/Knowledge Required:

PhD in relevant scientific discipline At least 10 years of biopharmaceutical industry experience, with focus on analytical development of glycoprotein and other protein-based therapeutics Demonstrated expertise with physicochemical methods (HPLC, CE, IEX, SEC, etc.) for monoclonal antibodies, fusion proteins, and other biologics. Experience in partnering with contract laboratories for method development, qualification, validation, and transfer Experience managing direct reports and directing laboratory research & development activities 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 is a plus 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

About Us

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.