Senior Scientist, Analytical Manufacturing Sciences

Employer
Celgene
Location
Summit, New Jersey, United States
Posted
Jun 17, 2019
Ref
1901436
Required Education
Masters Degree/MBA
Position Type
Full time
Req #: 1901436
Location: Summit, New Jersey, United States
Job Category: Biologics
Work Location: 556 Morris Avenue 07901
Organization: Biologics
Employee Status: Full-time
Job Type: Regular

This is an analytical role in Biologics Development and Manufacturing at Celgene. The successful candidate will contribute directly to global licensure applications, define strategy for follow-up measures, prior approval submissions and author/review associated regulatory filings. It also carries responsibility for providing analytical oversight for the transition of programs entering the commercial space following clinical development ownership. This individual will be a key member of the Analytical Sciences 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. Support the scientific, technical and operational efforts within Analytical Sciences in regards to physicochemical methods validation, technology transfer and life cycle maintenance.
2. Execute/ provide technical oversight and ownership of analytical methods, method revisions and improvements.
3. Share responsibility for the group's scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support product development.
4. 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
5. Identify and establish partnerships with external vendors to leverage capabilities not available in-house
6. Maintain currency with applicable global regulations and industry standards for analytical methods and testing of biological products. Respond to Health Authority queries regarding analytical methods/control strategy as appropriate.
7. Participate effectively in internal development programs and in external collaborations by representing the analytical development organization as needed

Skills/Knowledge Required:

1. M.S/Ph.D. in relevant scientific discipline required
2. Hands-on experience in methods development/qualification/validation chromatography (SEC, IEC, HIC), electrophoresis (cIEF, CE-SDS) and compendial methods (appearance, KF, CCI, pH).
3. Direct experience to support late stage product development and global commercial registration submissions
4. Proven leadership ability to align, motivate and empower team members
5. The ideal candidate will also have experience in interacting with CROs
6. Demonstrated ability for critical thinking, problem solving and innovation.
7. Ability to work independently, strong written and communication skills and experience working in a matrix organization.
8. Strong sense of value of investment and ability to develop cost-effective development plans
9. Effective communication, collaboration and negotiation
10. Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment

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.