Scientist II, Analytical Development, Biologics

Employer
Celgene
Location
Cambridge, Massachusetts, United States
Posted
Jun 16, 2019
Ref
1901449
Required Education
Doctorate/PHD/MD
Position Type
Full time
Req #: 1901449
Location: Cambridge, Massachusetts, United States
Job Category: Biologics
Work Location: 200 Cambridge Park Drive 02140
Organization: Biologics
Employee Status: Full-time
Job Type: Regular

The role carries responsibility for implementing analytical strategy for late-stage molecules to prepare for pivotal clinical trials and commercialization. The successful candidate will act as assistant AD lead on assigned projects. The incumbent will also have an opportunity to establish physicochemical capabilities within the newly built Cambridge Innovation Center laboratory.

Responsibilities Include:

1. Accountable for delivery of timely data to build product and process knowledge needed to make strategic decisions to meet Celgene project milestones and for regulatory submissions.
2. Guide development, optimization, and validation of analytical methods at contract testing laboratories.
3. Preparation and review of protocols and reports as well as overseeing study execution and data generation.
4. Responsible for operations and communications with contract testing laboratories to advance analytical development activities.
5. Participate effectively as a member of cross-functional teams, interacting effectively and transparently with functional representative within the Biologics Development & Manufacturing department and with other stakeholders in Quality, Regulatory CMC, and Project Leadership.
6. Establish physicochemical methods in newly built Cambridge Innovation Center laboratory.
7. Provide analytical characterization support and design and perform method troubleshooting experiments.

Skills/Knowledge Required:

1. PhD with at least 2 years of Biologics industry experience, focused on analytical development of protein-based therapeutics.
2. Experienced with qualification/validation and transfer of analytical methods.
3. Demonstrated hands-on expertise with physicochemical methods (HPLC, CE, cIEF, etc.) for monoclonal antibodies, fusion proteins, bispecifics, or other therapeutic proteins. Experience with mass spectrometry or biophysical methods is preferred.
4. Solid understanding of ICH and other regulatory guidelines.
5. Strong problem-solving skills and demonstrated ability for critical and creative thinking.
6. Excellent communication skills, both oral and written.

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.