Principal QC Scientist, Incoming CAR T

Summit, NJ
Mar 19, 2018
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- NJ- Summit West

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.

Principal QC Scientist, QC IncomingSummit, NJ

1.      Purpose and Scope of Position

The Principal Scientist, QC Incoming is responsible for creating SOPs, risk assessments, and specifications, with the associated justification, based on critical quality attributes for consumables and raw materials used to support clinical and commercial CAR T manufacturing.

2.      Required Competencies: Knowledge, Skills, and Abilities

  • Able to perform responsibilities independently with minimal management oversight.

  • Advanced ability to accurately and completely understand, follow, interpret, apply Global

Regulatory and cGMP requirements.

  • Advanced experience and knowledge of Compendia methods and requirements such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP)

  • Advanced technical writing skills.

  • Deep knowledge of AQL/ANSI Standards

  • Advanced ability to accurately and completely understand, follow, interpret and apply Global

Regulatory, cGMP requirements and ISO requirement for devices.

  • Advanced problem-solving ability/mentality, technically adept and logical.

  • Ability to represent the interests of the group on cross-functional teams.

  • Ability to set priorities of the group and manage timelines.

  • Ability to work with management locally and globally.

  • Advanced ability to communicate effectively with peers, department management and cross- functional peers.

3.      Duties and Responsibilities

Strong technical writing skills

  • Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. writes, reviews and updates SOPs.

  • Responsible as author and owner for material specifications. Setup testing requirements based on process and safety attributes.

  • Lead investigations to determine root causes, assign CAPAs and related tasks for incoming materials use in CAR-T manufacturing.

  • Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.

Drive and Manage projects within the group

  • Accepts responsibility for group projects; designs and executes experiments, analyzes results, and writes technical summary reports.

  • Capable of handling complex issues and solving problems with minimum guidance.

  • Prepare and present continuous improvement projects to management.

  • Utilize advanced scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.

  • Comprehensive understanding of guidelines and can independently develop, write and execute method, protocols, reports, and other related documents.

  • Assist management with investigations and deviations.

Carry out management authority for review and approval activities

  • Serve as author or technical reviewer of appropriate departmental procedures.

  • Review documentation as required by laboratory procedures.

  • Perform approvals for relevant laboratory activities.

Provide Guidance and Leadership

  • Perform on-the-job training (OJT) for laboratory employees.

  • Assist management with the development, implementation, and deployment of training.

  • Coach analyst on troubleshooting analytical methods and scientific equipment.

  • Teach junior scientists on theory and application of analytical methods.

  • Lead and develops best practices.

      Perform testing of in-coming raw materials and consumables.

  • Utilize advanced scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.

  • Capable of handling complex issues and solving problems with minimum guidance.

  • Manage testing performed at contract testing laboratories.

4.      Education and Experience

  • Bachelor's Degree required, preferable in Science.

  • Advanced Degree preferred.

  • 10-15 years of relevant work experience, preferable in a regulated environment.

  • An equivalent combination of education and experience may substitute.

5.      Working Conditions

  • The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.

  • The incumbent must analyze numerical values on a daily basis.

  • The incumbent will be working a laboratory setting up to six (6) hours per day.

  • The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.  The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.  Employees holding this position will be required to perform any other job-related duties as requested by management.

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.