Shire Senior Manufacturing Scientist in Lessines (Baxalta), Belgium

Summary:

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.)

Responsibilities:

Main Scope:

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

Job complexity:

  • 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:

Personal skills

  • 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

Technical skills

  • 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.