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.
Associate Director, QC Microbiology
Purpose and Scope of Position
This individual directs all operational aspects of the Quality Control Microbiology organization in support of Stability, raw material, in-process, finished product, environmental monitoring, and investigative related testing function. This individual also plays a critical role in supporting the site Aseptic validation program and the Gowning and Requalification program.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced knowledge of cGMP, OSHA, DEA, ISO, WHO, FDA, MHRA, PMDA, USP, JP and EP regulations as related to manufacture of sterile pharmaceutical products
- Advanced verbal, written communication skills with ability to tailor style for a wide variety of audiences
- Ability to collaborate cross functionally to drive operational and quality excellence
- Advanced organizational and time management skills
- Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision‑making skills
- Advanced teamwork and facilitation skills
- Advanced mentoring and coaching, influencing, negotiating and personal interaction skills Requires strategic thinking and ability to work independently
- Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team based environment
- Advanced knowledge of Quality Systems: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments
- Ability to interpret/write general, technical, and complex business documents
- Advanced knowledge and implementation of data integrity principles
- Ability to represent the department in regulatory inspections
- Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance
- Proficiency in MS Office applications
- Ability to develop and manage department budget
Duties and Responsibilities
Lead site Quality Control Microbiology and Environmental Monitoring departments:
- Directs all functional accountabilities for the Quality Control Microbiology Laboratories in accordance with organization’s policies and procedures.
- Ensures raw material and product release and stability testing activities are conducted in a timely manner.
- Ensures timely availability, reliability and accuracy of the test data.
- Directs the Environmental Monitoring program in support of the sterile manufacturing operations.
- Responsible for oversite of the Aseptic Gowning and Qualification program.
- Oversees the investigation of microbiological quality problems in raw materials, in-process materials, finished products, utilities and facilities, and environmental monitoring to ensure appropriate corrective actions to prevent reoccurrence and to recommend disposition of products.
- Participate in production planning process, prepare budgets, recommend capital expenditures for technology and equipment, and allocate human resources to support site manufacturing, projects, testing, and investigations.
- Reviews and approves laboratory data and investigations in accordance with cGMP’s and good documentation practices.
- Reviews/Approves all new and revised QC Microbiology related SOP’s to ensure compliance with cGMP’s.
- Ensure technical review of JP, BP, USP and Supplements, and the USP Pharmacopeial Forums to ensure department methodology and procedures are compliant with current standards.
- Participate in audits conducted by internal and regulatory agency representatives.
- Oversees site Aseptic Process validation program and provides technical input related to aseptic processing line configurations, changes, and sterility investigations.
Foster a well-trained, motivated and informed staff
- Ensure all unit staff receive training in cGMP’s SOP’s, Company Policies and safety, and that employees meet defined qualification requirements for the position to which they are assigned.
- Mentor department management, ensuring development of department staff to support department and site needs.
- Provide timely updates to department staff ensuring all shifts are included and involved.
- Work closely with Human Resources on Policy changes, interpretation and execution; Hiring of new employees, Employee disciplinary action, Performance Appraisals and Personnel Development.
Performs other tasks as assigned
Education and Experience
- Bachelor’s degree required, preferably in Chemistry, Microbiology, or related science
- Advanced degree preferred
- 10 years’ relevant work experience required
- 4 years of leadership experience with direct reports required
- An equivalent combination of education and experience may substitute
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.