The individual will be expected to provide global Material Qualification (MQ) support for Takeda biologics operations. The MQ activities for global support include, but are not limited to, the following areas:
Support selection of materials for cGMP production.
Perform qualifications of materials including data analysis and compilation of data and results into summary and final report.
Act as an SME for the MQ team.
Train and lead others.
Contribute and own/develop parts of the global MQ program.
Support/own global internal and external (for example CMO, contract labs) MQ efforts.
Support/present at internal and external regulatory inspections.
Provide technical assessments on change controls assessing proposed changes to qualified materials to identify requirements necessary to maintain qualified status.
Support/own MQ projects associated with internal and external changes.
Support and interface with global MQ community of practice where needed to ensure alignment and consistency with global practices.
Issues and Action log
Integrated Project Plan
Updates tailored to the intended audience at all levels of the organization
Adjusting to shifting business priorities
MS Project use
Multitasking and effective time management, i.e. managing multiple projects at the same time, based on current business priorities
Excellent verbal communication to all levels of the organization, suppliers, external labs, different geographies, different cultures, appropriate use of phone, WebEx, presentations
Excellent written communications skills, E-mail, IM
Ability to express complex scientific principles in a clear, concise and consistent way
Ability to express “bad news” along with options to resolve issues in a constructive way
Excellent command of English and the local language, additional language skills are beneficial
Ethics and Attitude
Perform with integrity
Objective evaluation off the facts and data
Science based data gathering, and evaluation
Embraces constant change
Positive and solution focused aptitude and attitude, “Can Do” mentality
Be Results Oriented
Be An Excellent Manager of Self and Others
40%: Design, perform, evaluate and document (cGLP, cGDP) experiments, collect, organize and document information required for Material Qualification.
20%: Manage / own Material Selection, Material Qualification and cGMP Manufacturing
20%: Interact with functional Business Partners, e.g. Product/Process Development, Procurement, Supplier Quality, Manufacturing and Project Management, globally
10%: Participate in project planning, execution, meetings, and updates, as required
5%: Provide updates to all levels of the organization, as appropriate
5%: Keep current on Material Qualification requirements
Education and Experience Requirements
Candidate is required to have the following education and experience:
A minimum of a Bachelor's of Science (or international equivalent) in Chemical/Biochemical Engineering or Bio/Chemistry with 5 to 7 years of experience or a Master’s of Science with 3 to 5 years of experience
Expert level understanding of pharmaceutical manufacturing, Chemistry and Material Science
Working understanding of description Statistics with experience in validation
Demonstrated experience with EU, US, cGMPs, Pharmacopoeias (USP, EP, JP)
Preferred if candidate also has the following experience:
Extensive experience in Material Qualifications
Understanding of Process Performance Qualifications
Understanding of Analytical Method development and Validation
Understanding of Equipment, Cleaning and other types of Validations
Other Job Requirements
The ability to support the global business across multiple time zones with domestic and/or international travel to supports projects as required.