We a recruiting, on behalf of our client, an experienced laboratory manager for QC analysis and analytical development. You will be responsible to manage the laboratory activities and manage a team of laboratory technicians.
The position is a temporary position to cover for a maternity leave.
▪ Responsible for managing the QC/analytical laboratory in accordance with cGMP and company requirements
▪ Responsible to resolve problems with instruments, test methods, lab chemicals, standards, and samples
▪ Overall responsibility for development and validation of innovative analytical methodologies, and support method transfers as needed
▪ Responsible to assure that all raw materials and finished goods are tested in accordance with GMP,
▪ Responsible to release raw material
▪ Organize and supervise the scientific activities carried out on the analytical techniques available in the laboratory (LC-MS, GC-MS, FTIR, …)
▪ Manage stability study protocol development, execution, data analysis and reporting
▪ Support continued business process improvement activities
▪ Cultivate and maintain relationships with key internal and external customers
▪ Initiate Change Controls to support change of equipment, specification documents and test methods
▪ Provide technical support to other QC activities as business needs arises
Maintain training records and GMP compliance
▪ Bachelor, Master degree in Chemistry, Pharmacy, or Biochemistry
▪ At least 5 years of QC/analytical development experience in biotech/pharmaceutical industry in a cGMP environment is required
▪ Experience in management; demonstrated leadership and organization skills
▪ Must have deep knowledge of a variety of analytical techniques such as HPLC, GC, FTIR, and other analytical techniques.
▪ Must have experience in analytical investigations, handling of OOS, OOT investigations
▪ General knowledge of the ICH guidelines and of the major pharmacopoeias
▪ Excellent team player with a strong ability to communicate within a multicultural environment, at all organizational levels
▪ Strong communication and technical writing skills