Shire Senior Material Qualification Specialist in Lexington, Massachusetts
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
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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.