Scientist I, Stability Chemist

Employer
Celgene
Location
Summit, NJ, US
Posted
Oct 06, 2018
Ref
1803428
Required Education
Bachelors Degree
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.

Scientist I, Analytical Development
Summit, NJ

SUPERVISOR

Director, Analytical Development

DEPARTMENT

Analytical Development, Stability

PREREQUISITES

BS in analytical science or in a pharmaceutical related field. Three + years of experience in a Drug Stability function within a Pharmaceutical company. A working knowledge of analytical laboratory operations and the evaluation of laboratory data is a definite plus.

Responsibilities include, but are not limited to, the following:
  • Performs the daily operations of the Celgene Stability Program under the direction of Director.
  • Assists the Stability Scientists in the performance of their responsibilities for the organization, maintenance, operation, and data review required for the Drug Stability Program which is utilized for the evaluation of the stability of Celgene developmental pharmaceutical drug substances and drug products. This program maintains the stability protocols for all developmental and clinical drug substances and drug products according to ICH/FDA guidelines and approved submissions/commitments.
  • Is well-versed in the operation of a Stability function and is able to independently undertake major project assignments and drive them to completion with a minimum of supervision.
  • Is technically experienced and is a valued resource within the department.
  • Assures that stability samples for all projects have been properly placed on stability at the correct stability conditions. Follows the requirements of the Stability Protocols and helps maintain all required timelines (sample maintenance and documentation of test results). Helps maintain stability documentation, as required. Interacts with the QC and R&D laboratories as well as with the appropriate Quality Assurance, Technical Operations and Regulatory areas as necessary.
  • Is responsible for the accurate and timely tracking of stability data. Has a background in the statistical evaluation of Stability data and can effectively trend this data utilizing programs designed for this function.
  • Helps maintain Stability data evaluation and the timely delivery of customer-oriented data and documentation.
  • Is able to effectively review analytical data to recognize potential trends and alert the Stability Manager.
  • Compliance Systems: Helps maintain the activities of the Stability Area in compliance with cGMPs, SOPs, good documentation practices and safety standards in accordance with Corporate, Regulatory and timeline expectations.
  • Stores, maintains inventory and requalification schedules, creates and updates Purity Statements, performs distribution of Reference Standards and Reference Materials for developmental and commercial products.
  • Creates Stability Reports to summarize stability data for developmental drug substances and drug products and facilitates the joint review and approval by the SMEs from Analytical Development and Quality Assurance.
  • Responsible to streamline and continuously improve stability operations including stability reports, creation, revision of Stability SOPs and processes for efficiency and cGMP compliance.
  • Ensures maintenance of continuous cGMP compliance in day to day Stability Operations by themselves and others below their level such as Associates Scientists.


Skills/Knowledge Required:
  • BS in Analytical Chemistry or relevant scientific discipline
  • 3+ years of experience within a Stability function in pharmaceutical industry
  • Experienced in the evaluation of analytical data including statistical interpretation of Stability data. Is able to assist others in the evaluation of data from a statistical perspective.
  • Familiar with cGMP requirements
  • Good working knowledge of common business software
  • Knowledge of stability LIMS (e.g.- LabWare) is desired
  • Excellent verbal and written communication skills


#LI-POST

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.