Shire Head of US TS External Manufacturing in Lexington, Massachusetts
The Head of Technical Services External Manufacturing, part of the PDTS (Process Development and Technical Services) organization, is responsible for providing guidance and technical support to the External Manufacturing Organisation. He/She is making the liason between the Technical Process Experts and the CMOs, and ensures to define and prioritize the on-going developments/improvements, and problem solvings. Key in this role is to ensure adequate process/product support to ensure uninterrupted supply.
1.Assure process robustness/harmonization and supply reliability by controlling the manufacturing process life cycle and authority submission to routine production
2.Responsible for providing a reliable yield status (actual data) and accurate yield forecasts for all plasma products together with strategies to meet the yield targets
3.Ensure adequate process support on site at the manufacturing site
4.Provide Technical Training support
5.Support TT Execution
EDUCATION AND EXPERIENCE:
Master or PhD degree in technical / scientific education, preferably biochemistry, biotechnology or pharma - process engineering is essential
At least 10 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
KNOWLEDGE, SKILLS AND ABILITY:
Broad knowledge and experience within the GMP environment, Lean and SixSigma and regulatory affairs
Very strong and proven leadership experience and capability
Very successful track record of change management projects and processes
High level of customer orientation and organizational skills
Flexible in mind / out of the box thinker
Enthusiastic, decisive, motivating and convincing personality
International background appreciated
Excellent communication skills, verbal and written communication skills
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, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.