Direct message the job poster from mAbxience.
From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a QC CMO/CDMO Projects Supervisor for our plant in León.
General Responsibility Along with Quality Control Analytical Manager, manage from implementation to maintenance all activities related to CMO/CDMO new molecules.
Suitable day-to-day organization within area and designated technicians and analysts for CMO/CDMO Projects.
In coordination with Quality Control Manager, ensure method implementation in Quality Control.
Specific Responsibilities Plan, organize, and manage resources effectively to meet CMO/CDMO project timelines.CMO Projects follow up, using a suitable tool (i.e.
projects, think cell…).Collaborate with clients in design, adjustment, implementation, transfer and validation of analytical methods.Collaborate with MSAT in process validation protocols of new CMO molecules.Validation and transfer activities of analytical methods from CMO projects.Ensure the new methods are correctly implemented in QC commercial departments and give support to them when needed.Control and archive documentation related to qualification and validation.Overseeing analytical method validation, verification, and transfer activities in accordance with regulatory guidelines and company standards.Ensuring compliance with Compendial (USP, EP, JP) and ICH requirements for analytical methods.Assist in the preparation of quotations for projects.Assist in the preparation of budget related to CMO/CDMO projects.
Suggest acquiring equipment and devices needed for new CMO projects.Management and execution of various stability studies according to GMP standards and procedures.Conducting investigations into complaints and deviations and reporting this to QA.Taking care of corrective and preventive measures in the event of complaints and deviations.
Manage change control documentation and CAPA.Participate in internal and external audits and regulatory inspections.Collaborate with Qualification and Validation personnel in design, adjustment, implementation and qualification of equipment to be used.Carry out activities for training required for personnel from QC CMO Projects.Constantly keep themselves updated on progress of EU and USA standards so as to keep GMP compliance updated.Provide help in start-up, qualification/validation of equipment involved in QC labs.Provide technical support during audits (internal and external audits).Identification of needs and possibilities of improvement in area.Manage and use computerized systems of general management so as to issue and control documents and analytical records of their responsibility.Requirements and personal skills Education: Bachelor of Sciences.Languages: Fluent in Spanish and English.Experience: >5 years in the pharmaceutical/biotechnological industry in a similar role.Specific Knowledge: Biochemical, chemical and immunochemical techniques.
Validations.
Tech transfer.
CMO/CDMO projects.Travels: Available for sporadic travelling (1-2 a year).Personal skills: Management of work teams, organization skills, customer oriented, communication skills, proactivity and flexibility.We offer a permanent contract to join a growing pharmaceutical company.
Life and accident insurance.Free company canteen.Free online training platform.Free online library.Social, physical and emotional well-being platform.mAbxience is committed to equal opportunities.
We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance. Seniority levelMid-Senior levelEmployment typeFull-timeJob functionProduct Management, Project Management, and Quality AssuranceIndustriesBiotechnology Research and Pharmaceutical Manufacturing
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