Senior Material Qualification Specialist
The individual will be expected to provide global Material Qualification (MQ) support for Shire 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
- Project Prioritization
- 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
- Data driven
- Science based data gathering, and evaluation
- Embraces constant change
- Positive and solution focused aptitude and attitude, “Can Do” mentality
- Be Positive
- Be Accountable
- 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.
Mitteilung an Anstellungs-/Einstellungsagenten:
Anstellungs-/Einstellungsagenten können nur Kandidaten für freie Stellen einreichen, wenn sie eine schriftliche Erlaubnis der Recruiting-Abteilung von Shire dafür haben. Jede Einreichung eines Kandidaten einer Agentur kann nur für Positionen eingereicht werden, die über das Agenturportal für die Agentur geöffnet sind. Shire wird eine Vergütung für einen eingereichten oder vorgeschlagenen Kandidaten nur bezahlen, wenn es einen vollständig ausgeführten Vertrag zwischen dem Anstellungs-/Einstellungsagenten und Shire gibt und der Kandidat über das Agenturportal eingereicht wird. Kandidaten, die von Anstellungs-/Einstellungsagenten ohne vollständig ausgeführten Vertrag eingereicht oder vorgeschlagen werden oder über diese Seite eingereicht werden, gelten nicht als Teil einer Beschäftigung, für die die Agentur Vergütung beanspruchen kann.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.