CMC Consultant

  • Randstad
  • 4000.00 - 7000.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a respected partner for life sciences companies.

Client

Our client is a respected partner for life sciences companies. Providing knowledge and expertise in phases ranging from drug development to commercial manufacturing. One of their expertises is the engineering, commissioning and qualification in pharmaceutical projects. Currently they are looking for a Tech Transfer Consultant to strenghten their team of Consultants.

Requirements

Job requirements
  • A University or Higher Professional Education (HBO) degree in biotechnology, chemical technology, biochemistry, pharmacy or similar;
  • 7-10 years of relevant work experience in the (bio)pharmaceutical industry, at different companies;
  • 5-10 years of relevant work experience in CMC development of small molecules, biologicals or ATMP products, including experience with Quality by Design and/or knowledge of qualification and validation of analytical methods;
  • extensive knowledge of and experience with upscaling and (bio)pharmaceutical production;
  • proven CMC project management experience and knowledge of and experience with project management tools (Prince2 or similar);
  • experience in drafting project plans, study plans, validation documents and (financial) reports;
  • experience in working with external parties to supply materials or conduct studies;
  • extensive knowledge of pharmaceutical production and familiarity with cGMP requirements and other relevant regulations and guidelines;
  • knowledge of statistics and process control systems is an advantage;
  • affinity with registration processes for new or modified products within the EU and/or the US is an advantage;
  • effective communication skills, high proficiency in English. Preferably also Dutch and/or Afrikaans.

Your profile
  • Pro-active, pragmatic, flexible and customer-oriented;
  • accustomed to balancing business and/or operational targets and delivering high- quality work;
  • accustomed to working in a dynamic organisation;
  • thorough and systematic approach;
  • capable of advising, persuading and motivating others;
  • accustomed to communicating at both management and operational level;
  • willing to take ownership;
  • team player.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

TAGCLOUD

Sander Pupella

Interested

Send your resume to sander@tailorminds.com referring to job id (1119)

More information?

Please contact Sander Pupella working at our office in Zoetermeer, phone number +31 6-13140754

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