Sr Principal Scientist, Biologics MS&T

Employer
Celgene
Location
Summit, NJ, US
Posted
Nov 05, 2018
Ref
1803796
Required Education
Doctorate/PHD/MD
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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.

NOTIFICATION OF JOB OPENINGS

Eligible for Employee Referral Program
POSITION

Sr Principal Scientist, Biologics Analytical MS&T

SUPERVISOR

Senior Director

DEPARTMENT

Biologics Development and Manufacturing
PREREQUISITES

Minimum of 10 years industrial experience in Biologics Development.

Ph.D. in relevant science field

This is a senior 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:

Lead scientific, technical and operational efforts within Analytical Sciences in regards to physicochemical methods validation, technology transfer and life cycle maintenance. Provide technical oversight and ownership of analytical methods, method revisions and improvements. Share responsibility for the group's scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support product development. 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 Identify and establish partnerships with external vendors to leverage capabilities not available in-house 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. Participate effectively in internal development programs and in external collaborations by representing the analytical development organization as needed Develop the analytical staff to function effectively in cross-functional teams and collaborations. Maintain a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs. Budget and track external expenses for CMO/CRO analytical activities. Participate in CMO/CRO selection, management and auditing as needed. Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Biologics Development.

Skills/Knowledge Required:

Ph.D. in relevant scientific discipline required Demonstrated track record in methods development/qualification/validation chromatography (SEC, IEC, HIC), electrophoresis (cIEF, CE-SDS) and compendial methods (appearance, KF, CCI, pH). Direct experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization, to support late stage product development and global commercial registration submissions Proven leadership ability to align, motivate and empower team members The ideal candidate will also have experience in interacting with CROs Demonstrated ability for critical thinking, problem solving and innovation. Ability to work independently, strong written and communication skills and experience working in a matrix organization. Strong sense of value of investment and ability to develop cost-effective development plans 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.