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.
1. Purpose and Scope of Position
The Supervisor, Manufacturing is responsible for shift management, direction and coordination of
production personnel, processes, schedule, and is expected to maintain a compliant, effective and
efficient operation that meets or exceeds site and corporate goals and objectives. The Supervisor
is responsible for ensuring the proper execution of production activities within manufacturing
operations and that work will be performed in complete accordance with all cGMP’s. In addition,
work will be performed in complete accordance with all SOPs, Specifications, Batch Records,
regulatory expectations, and company policies. This position does not have set hours, and may
require shift work and flexibility in scheduling of “set” shift hours at times, based on production
demands or extraordinary circumstances.
2. Required Competencies: Knowledge, Skills, and Abilities
· Advanced knowledge of Microsoft Applications (i.e. charting, presentations, etc.) and other computer based systems utilized in the manufacturing department (i.e. MES, HMI’s, etc.).
· Advanced proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
· Advanced written and verbal communication skills.
· Functional job specific proficiency in mathematics.
· Practical understanding and demonstration of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.
· Ability to pass a full physical including a respiratory certification with annual monitoring.
· Ability to stand up to 8 hrs/day, utilizing controlled movements.
· Practical understanding and demonstration of specialized manufacturing equipment operational theory in the setup and trouble-shooting of manufacturing equipment.
· Ability to execute complex activities both independently and in a team environment.
· Continuous Improvement Champion open to change and implementation of ideas brought forward by operators. Facilitate execution of these ideas and develop the team while doing so.
3. Duties and Responsibilities
· Provides effective leadership to the Manufacturing function
· Consistently projects a positive attitude and example for other department team members.
· Hiring of new employees, Employee disciplinary action, Performance Appraisals and Personnel
· Work with department management on the manufacturing budget to supports the production plan.
· Executes daily tasks per written procedures.
· Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively.
· Continuously updates job knowledge by staying current with leadership, Industry trends and other applicable standards.
· Trains and mentor’s department personnel to the tasks that are performed within their assigned department.
· Champion/implement CI projects
· Openly communicate with management
· Conduct department monthly meetings.
· Work across levels to establish cascading goals that support department goals.
· Ensure employees have the resources needed to meet or exceed their goals.
· Ensure adequate trained personnel are available to perform all manufacturing activities.
· Maintain manufacturing areas that are compliant, efficient, effective and safe.
· Work closely with Human Resources/ Management on Policy changes, interpretation and execution.
· Work closely with Material Management and Quality regarding component problems.
· Work closely across applicable departments so support customer relationships and goals.
· Performs other tasks as assigned.
4. Education and Experience
· High school diploma or equivalent required.
· Bachelor’s degree preferred.
· 4 years of relevant work experience required, preferably in the Pharmaceutical industry.
· Equivalent combination of experience/ education is acceptable.
5. Working Conditions
· The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 8
hours, approximately 5 times per week.
· Aseptic Operations: Requires aseptic gowning into sterile environment.
· Finishing Operations: Requires 20/20 correctable vision and must be able to successfully pass
a TITMUS visual examination annually.
· The incumbent may be working around hazardous materials to include chemical agents at least
8 hours per day.
· The incumbent may be in a standing position for at least 8 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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.