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QC & Analytical Development Laboratory Manager

Ref: JN-092021-195900

Publié le 30 September 2021
Sciences de la vie

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