Celgene Associate Director, Quality Control in Boudry, Switzerland
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.
This position is responsible to manage the Quality Control Laboratory (Chemistry and Microbiology) of
Celgene International in Boudry.
As a key player of the release of the product, this position will also be working closely with QA, manufacturing and logistics departments on site and globally.
- SKILLS/KNOWLEDGE REQUIRED
· University studies in chemistry, biochemistry or pharmacy.
· +10 years of experience in a QC lab of a pharmaceutical company or other related industry.
· Excellent knowledge of GMP, FDA and other regulatory bodies requirements.
· Solid knowledge of analytical technologies.
· Solid knowledge in the process validation field and in the validation of procedures and systems.
· Excellent written and communication skills.
· Excellent interpersonal, collaborative and organizational skills.
· Ability to work independently, yet effectively in a team environment
· Excellent team spirit.
· Ability to take decision.
· High credibility and reliability
· Excellent investigational and problem-solving skills
· Ability to motivate teams
· Basic financial knowledge
· Fluent in English, French a plus.
· Knowledge of most common office software and of IT-principles.
- DUTIES AND RESPONSIBILITIES
· Responsible for execution of incoming raw material, API and drug product release and stability testing.
· Responsible to review, approve and QC release raw data and analytical results generated in the QC labs.
· Responsible for Environmental Monitoring
· Support Manufacturing Department in all their activities (worldwide supply of the formulae produced at Celgene International, qualification and validation activities etc.)
· Insures good running of all laboratories and stability room equipment.
· Business owner of local external company (contract laboratories).
· Overall responsibility of sampling.
· Insures good stocking conditions for samples, raw material and reagents.
b. GMP activities
· Definition and implementation of the necessary rules to ensure and maintain state of the art GMP level for the QC laboratories. Adhere to rules defined for the production building.
· Participate to audits performed by health authorities
· In charge of the implementation and follow up of corrective actions for the QC labs.
c. Team management
· Defines the necessary actions to be implemented to manage the QC team
· In charge of budget definition and follow up
· In charge of the recruitment strategy
· In charge of the employee development program of the QC team
· In charge of the definition of the QC investment strategy and support department investment strategy
d. Project management
· Management of specific project
· Supports global project initiatives and implementation
· Line Managers shall provide a safe and healthy work environment for their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.
· Work closely with EHS to evaluate hazards and perform risk analysis
· Ensure that staff (including short duration and temporary contracts) is properly informed on hazards, and trained to act in consequence
· Promote safe practices and behaviors, verify that EHS rules are implemented and respected
· Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future
University studies in chemistry, biochemistry or pharmacy. +10 years’ experience in a QC lab of a pharmaceutical company or other related industry.
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.
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE