Shire Senior Manufacturing Scientist in Lessines (Baxalta), Belgium
Enable integrative work of Product Development Technical Services (PDTS) team and team members throughout product life cycle including process improvements and developing product specific strategies
Drive, lead and support strategies globally and cross-functionally with internal and external business partners and other external stakeholders (industry associations, regulatory authorities, etc.)
Establishes operational objectives and assignments and delegates assignments to others if relevant. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect
Resolve complex problems with major business impact
Responsible for the performance and results of the applicable PDTS group
Interpret internal and external issues and recommend risk based solutions and best practices
Represent function globally or in cross-functional programs/ projects/processes
Act as an expert within own discipline (interdisciplinary skillset)
Proactively drive improvement by applying innovative, creative and purpose driven solutions
Coach other experts
Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Acts as advisor to meet schedules and/or resolve technical problems.
Develops and administers budgets, schedules, and performance requirements
Operations involvement / Leadership
Good technical problem solving skills
In depth understanding on relevant manufacturing process, including actual operations on manufacturing floor
Drive decisions within the area of responsibility - identify ‘must haves’, ‘preferences’ and ‘nice to haves’
Ability to lead global and interdisciplinary teams for problem solving or project execution
Lead projects with manageable risks and resource requirements
Act as resource for colleagues with less experience
Education and experience
Jobs in PDTS within this career band require a specific personal skillset reflecting their interdisciplinary & strategic impact:
Business acumen, strong strategic and process thinking
High degree of internal/external customer sensitivity/acumen
Uncompromised dedication to quality
Excellent written and verbal communication skills
Quick perception, analytical and abstract reasoning, solution oriented thinking, organizational talent, grasping new focus areas quickly
Ability to cope with pressure (flexibility in regard to continuous changing demands).
Cultural awareness when dealing with customers/regulators with a different cultural background
BS degree in a scientific discipline and minimum 7 years of experience, MS degree with minimum 6 years of experience, or PhD with minimum 4 years of experience (scientific discipline in biotechnology, biochemistry, pharmacy, process engineering or equivalent)
Profound knowledge and expertise in biochemistry, protein purification, and engineering principles
Experience in developing regulatory strategies and in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
Good knowledge of and appropriate compliance with guidelines as well as Shire internal requirements
Excellent knowledge of statistics and DOE principles
Ability to design robust experiments that answer the question being asked
Good knowledge of risk assessment tools
Basic understanding of external environment (political, economic, ecological, social, technical and legal)
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.