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Analytical Development Associate Director/ Principal Scientist

Employer
Entrust Resource Solutions
Location
Belgium (BE)
Salary
Very Attractive Salary
Closing date
10 Feb 2022
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Job Details

Analytical development, small molecules and drug development… If this sounds like your area of expertise, then we have just the role for you!

Join a renowned global biotechnology organisation and become the face and voice of the biopharmaceutics groups supporting the analytical method development of the small molecules portfolio. Better yet, this exciting opportunity comes with flexible home working when you’re not onsite in the beautiful town of Antwerp, Belgium.

Responsibilities

The Analytical Integrator will lead a global sub team of AD scientists including Method Development/ Validation, Clinical Release & Stability, Advanced Material Characterization & Investigations, Pharmaceutical and Material Sciences, and Dissolution Sciences, integrating AD activities so that deliverables are being met balancing cost/time/quality. Specifically, the Scientific Integrator (SI) will provide strategic and scientific technical leadership, ensuring the focus on scientific excellence is maintained within the AD/CMC teams.

Main responsibilities will include:

  • This role will be focused on defining and managing execution of the Analytical Development strategy and activities across all clinical and commercial phases, through in depth understanding of the compound properties and TPP (Target Product Profile), aligned with AD function, CMC team and CDT (Compound Development Team) who sets the overall compound strategy
  • Ensuring appropriate design, from feasibility to final commercialization, of analytical methods/specifications/stability/characterisation in alignment with functional strategic technical platforms
  • Specification management and setting retest period/shelf life for drug substance and drug products
  • The scientific integrator will overview the project as core member of the CMC team, and has key interactions with API and DP scientific integrators, supply chain, Quality Assurance, CMC Regulatory Affairs, preclinical, clinical, Non-Clinical Safety and external consultants and vendors
  • Ensuring alignment/compliance with relevant FDA/EMA/ICH/JP/CHP/ANVISA guidance
  • Authoring relevant submission documents/agency responses, ensuring analytical deliverables are met & aligning technical content
  • Responsible for and driving the analytical governance review for the assigned projects
  • Managing the AD risk register and defining mitigation plans and ensuring rapid identification and resolution of problems
  • Managing analytical project budgeting

 

Job Requirement

  • Ph.D. degree with post-doctoral experience and minimum 6 years of business experience of small molecule analytical development, CMC product development or other relevant product development experience.
  • A minimum of 6 years pharmaceutical industry experience with strong demonstrated scientific acumen.
  • Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development processes
  • Proven knowledge of analytical or biochemistry in a R&D environment
  • Demonstrated project management skills and leadership experience
  • The ability to execute and get results through leading others
  • Ability to foster team productivity and cohesiveness in a complex matrix environment
  • Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organisation issues, structures and dynamics.

Company

Entrust Resource Solutions (ERS) is a resourcing group comprising of three like-minded consultancies operating within the life sciences, healthcare and technology industries Globally. – Entrust People Ltd – Horton International UK Ltd – SCI Search and Selection Ltd

Finding the best talent in the market is critical to the growth and ongoing improvement of every business. We help our clients navigate talent demands from bench to board with our tailored search and resourcing solutions. With our in-house knowledge of the life sciences industry, we have developed a consultative, proactive and creative recruitment solution for our clients across the UK, Europe & US. We tailor our strategy to best suit the needs of each individual client, working with them to understand their current and future growth plans. 

We specialise in the following disciplines across UK wide Life Science / scientific sectors :-

  • Research and Development - Analytical Chemistry, Toxicology, Drug Discovery, Formulation, Process Chemistry, Quality, Validation, Project Management, Synthetic / Organic Chemistry
  • Pharmaceutical Development - Clinical Development, Clinical Operations, Medical Quality, Data Management, Regulatory Affairs, Safety, Bio Statistics
  • Technical Support - Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control, GMP Operations
  • Commercial - Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control, GMP Ops

Our talented team of scientists and life science experts have a wealth of experience across the UK and European markets. From our three offices across the UK, we service roles from bench to board, supporting your full hiring needs, including executive search, permanent and contingent talent planning.

We manage the full hiring process, reliably and comprehensively, until a successful placement is made. We offer our clients a first-class service, from understanding your current and future hiring plans and comprehensive candidate searches, to timely and relevant CVs for interview consideration and offer negotiation, all with regular communication on our progress.

For candidates, we offer an unparalleled understanding of their industry and intended career progression, enabling us to secure the best fitting roles available in the industry.

Website : www. entrustrs.com

Phone : 01224 907990 / 01606 818290

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Website
Telephone
01224 907990 / 01606 818290
Location
Head Office
River Court
5 West Victoria Dock Road
Dundee
DD1 13JT
United Kingdom
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