Celgene Associate Director, Manufacturing Technical Services in BOUDRY, NebraskaSwitzerland
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.
Celgene International Headquarters is located in Boudry (NE) with manufacturing capabilities for solid dosages form. An additional manufacturing plant is being built in Couvet (NE) to support our growth.
This position is in charge of the validation and qualification activities, maintenance activities (Process equipment / Utilities / Calibration), at the Boudry site.
Reporting to the Head of Manufacturing this function, play a key role by ensuring compliance of these responsibilities with cGMP, and provide strong technical deliverable.
In a very dynamic environment, we are looking for a person with a broad pharma experience and strong knowledge of regulatory and operating requirements in a global setting are required.
A solid experience in team management and excellent cross-functional and communication skills are required.
Duties & responsibilities:
a. Responsible to maintain, qualified equipment and validated system (Including computerized systems) in compliance with cGMP, as well as with policies, guidelines and procedures
b. Provide technical support to users related to process equipment, utilities
c. Develop and support equipment calibration / maintenance program, validations plan with associated documentations needs
d. Is strongly involved in inspections and compliance audits, in close collaboration with QA
e. Collaborates closely in Boudry with the heads of QC laboratories , Production and Packaging and with Manufacturing Operations Services to ensure optimal processes and communication
f. Assure compliance with the site validation master plan, and assist with potential new facility start up operation in Boudry, and new drug product introduction ( FAT/SAT/IOQ/PQ)
g. Participates in and supports complex deviation investigations, change management, and critical quality complaint resolution activities
h. Fosters continuous process improvement and ensures alignment and close collaboration with Couvet plant
i. Proposes, sponsors, and manages investment projects, participates to the investment strategy and budget definitions, and is responsible for the department’s budget
j. Builds and manages the team in a motivating and collaborative spirit, leads by example and develops the team
k. Follows up metrics and KPI’s and reports on routing activities and on projects to upper management
l. Ensures compliance to EHS requirements for Manufacturing Technical Services activities
Skills & knowledge required:
• BS in Engineering
• 8+ years in Validation/Qualification with Technical expertise in a pharmaceutical company, and Computerized system validation skills
• Strong knowledge of international GxP regulations, and FDA/EMEA/Swissmedic regulatory requirements
• Broad experience in inspections and compliance audits
• Experience in supporting regulatory filings
• Demonstrated ability to continue to develop the team, foster cohesion and motivation and to lead effectively the department
• Must possess strong verbal and communication skills, and a well-developed ability to constructively work across functional areas and levels to achieve results
• Decisive with strong analytical and problem solving skills
• Fluent in French and English
• Solid understanding of solid oral dosage forms a plus
• 6 Sigma and/or Lean expertise a plus
Associate Director, Manufacturing Technical Services
Location: BOUDRY, NE, CH
Job ID: 17001406