Principal Specialist, Validation & Lab Oversight

Employer
Celgene
Location
Warren, NJ, US
Posted
Dec 05, 2018
Ref
1802539
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1802539
Location: Warren, New Jersey, United States
Job Category: Quality
Work Location: 7 Powder Horn Drive 07059
Organization: Quality Assurance
Employee Status: Full-time
Job Type: Regular

OBJECTIVES OF THIS ROLE, DUTIES AND RESPONSIBILITIES
The Principal Specialist is responsible for providing quality oversight in accordance with Celgene policies, standards, procedures and global cGMPs for site development operations; specifically, management of development activities associated with a portfolio of one to three pre-clinical or clinical stage cellular therapy products.
  • Ensuring accurate and timely review and approval of studies, protocols and reports generated by the AR&D, Process Development, Product Characterization and Tech Transfer/MS&T groups;
  • Review and approval of qualification packages for equipment used in the manufacturing and testing processes;
  • Review and approval of qualification documents related to facility/utility renovations;
  • Participate in cross-functional groups to complete risk assessments related to a variety of activities associated with cellular therapy manufacturing and testing;
  • Assist in the planning and execution of aseptic process validation and environmental monitoring performance qualification studies;
  • Drive continuous improvement of systems and processes required for technical transfer, product development and preparation for first-in-human trials;

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Our ideal candidate is resourceful, detail-oriented and self-sufficient. You'll build relationships, internally and externally, and influence and lead others effectively. You're a confident decision maker, applying critical review and interpretation of the scientific information presented all while ensuring consistency with quality risk management principles. As the Principal Quality Assurance Specialist responsible for quality assurance oversight of development operations of a portfolio of early phase products, you'll take an active role in ensuring the quality of work being delivered and will be the subject matter expert for the global QA team for your set of products. In addition:
  • Must have GMP, Quality, and in-depth risk management knowledge.
  • Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function.
  • Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
  • Must have strong authorship and be able to critically review studies, protocols and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
  • Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes.
  • Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams
  • Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
  • Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
  • Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

EDUCATION AND EXPERIENCE
  • B.S. degree required.
  • Minimum of seven years of experience in the pharmaceutical or related industry.
  • Equivalent combination of education and experience acceptable.

WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.

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.