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.
Assoc Director, Quality Oversight of Internal Manufacturing & Testing
Executive Director, Development QA, Global Quality Operations
Prerequisites (As Applicable)
Minimum of a BS degree in Chemistry, Pharmacy, or similar scientific field.
10-12 years of experience in GMP environment for manufacturing sterile and/or non-sterile pharmaceutical drugs (drug substance and/or bulk drug product). Prior experience in Quality is a must. Prior quality oversight of analytical laboratories is preferred, but not required.
PURPOSE AND SCOPE OF POSITION:
The Position is responsible for quality oversight of cGMP operations of manufacturing and testing facilities for non-sterile and/or sterile clinical products at the NJ Summit site. The operations include DS/DP manufacturing and analytical testing. The position will also be responsible for quality oversight of commissioning/qualification of equipment, instrument, facility, engineering, and utilities for the same facilities. The position may have direct reports.
Knowledge, Skills, and Abilities
Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH) for manufacturing and testing of Sterile and/or non-sterile investigational material.
Well-versed in manufacturing and testing requirements for Investigational Materials with an emphasis on good documentation practices, data integrity, compliance to Celgene and regulatory requirements.
Quality expert in the area of instrument/equipment qualification related requirements, documents, and procedures.
Excellent investigational and QA problem solving skills. Analytical mind, ability to assess new situations to define and implement the appropriate QA action plan.
Thorough knowledge of the Pharmaceutical Development Process as evidenced by prior experience of working in Rx drug development CMC areas. Knowledge of multiple pharmaceutical dosage forms (Solids /Parenteral etc.) would be considered an advantage.
Work independently, yet effectively in a team environment.
Strong attention to detail, excellent verbal and written communication skills.
Teamwork oriented and ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
DUTIES AND RESPONSIBILITIES
Member of manufacturing teams to provide Quality input. Partners with technical SMEs to develop and approve the strategy for cGMP operations of manufacturing and testing of Investigational Materials (drug substance and drug product; non-sterile / sterile).
Final Quality reviewer/approver for GMP documentation
- SOPs, Work Practices, and associated Forms
- IOQ, Commissioning, and/or Qualification protocols and reports
- Pre-executed and executed manufacturing batch records
- Change Requests
- Deviations, Investigations, and CAPAs.
Provide Quality oversight of all Metrology & Validation service activities
- SOPs and associated forms
- Validation plans and protocols
- IQ/OQ/PQ documents (equipment and software related)
- User Requirement Specifications
Responsible for change control management through the development process to include impact assessments, tracking, and implementation. Also, responsible Quality member for oversight of all key Quality Systems associated with the facilities/laboratories including Change Controls, Deviations, CAPAs, and Complaints.
Developing policies and procedures for internal manufacturing facilities and/or testing laboratories based on regulations, industry guidelines and corporate requirements.
Implements new policies/systems in keeping with constantly changing/emerging FDA/industry requirements.
Assures Quality oversight to meet or exceed industry and regulatory (e.g., US, EU) trends/expectations.
Support internal and external audits as manufacturing QA SME.
Perform internal Quality checks to further strengthen and optimize processes.
Requires minimal guidance to complete tasks; ability to perform self-directed tasks and making non-routine decisions. Consults with supervisor for decisions outside of established processes and provides Quality oversight for experienced professional employees.
Exhibits excellent leadership and fosters teamwork to create an environment of support that leads to positive motivation and increase productivity of group personnel. Manages conflict and issues with internal and external customers.
EDUCATION AND EXPERIENCE (As Applicable)
Minimum of B.S. degree preferably in Chemistry, Pharmacy, or similar Science field.
Minimum 15 years of experience in GMP environment of manufacturing pharmaceutical drugs (drug substance and/or bulk drug product). Prior experience in Quality is a must. Prior experience with analytical laboratories is preferred, but not required.
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.
The position does require routine walk-throughs (hours within a day; once or twice a week) of manufacturing facilities and/or analytical testing laboratories.
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.