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Job Details

Process Design CMC Manager - Biotechnology

Company: RBW Consulting
Location:
Reference: AC/PDCMC/SWI
Closing Date: 27 Nov 17
Type: Permanent
Salary (£): Competitive
Benefits: EXCELLENT

Job Summary:

Process Design CMC Manager - Biotechnology - Newly created function

Requirements:

I am currently assisting one of the most exciting Biological organisations at present who are currently on an ambitious development drive on a long-term basis. Due to their global development plans, they are currently looking to fulfil a number of integral functions in order to maximise their plans. At present, we are now supporting the recruitment efforts for a newly created function within the group of a ‘Process Design CMC Manager’ whose function will be highly visible within this global Biotech. 

Responsibilities

  • Designing of a CMC strategies and implementing QbD principals and methodologies for new product development efforts
  • Develop a cost effective commercial manufacturing and analytical strategy for development products or for commercialised products which are having a major process changes using QbD principals
  • Contribute and deliver on CMC documentation for submission strategy and implementation for Quality modules
  • Key contribution to development project efforts and review technical data related to such projects
  • This may include such areas like:
  • Design of Experiment protocols
  • Qualification of scale down models
  • Analytical method development
  • Process and analytical method validation
  • Stability plans
  • Tech transfer and CMC RA strategy
  • Process change with potential program impact
  • Accountable for the generation of Risk assessments and reports through using QbD principles
  • Consult and support process comparability and validation strategies
  • Play an active part in project expert teams
  • Ensure global and local policies are adhered to (QbD)
  • Identify and create new processes and procedures to improve efficiency
  • Closely collaborate with R&D teams to draft gap assessments
  • Champion the need for CMC efforts
  • Overall aim is to ensure a robust and cost-effective process is created to achieve consistently high results for quality products

Skills required

  • Ideally educated in the field of Biology, Biochemistry or a related field
  • At least 6-8 years’ experience working in the Biopharmaceutical/Pharmaceutical industry related to manufacturing operations, process design and process validation
  • Key skills as a Project Leader are a must
  • Ideally skilled in Product development
  • QbD experience and understanding would be a distinct advantage
  • Thorough experience of CMC requirements in Biotechnology is essential
  • Regulatory technical writing would be preferred
  • Can work office based in Switzerland
  • Fluent in English

 

At RBW Consulting Ltd, every one of our consultants has the benefit of multiple years’ experience in helping Pharmaceutical & Medical Device Professionals find the right career step for their current and future aspirations. With unrivalled industry knowledge and network in Biotech’s, Pharmaceutical and Medical Device Companies throughout the UK, Switzerland and Europe, we would be delighted to speak with you about the role you are looking for.

For a confidential chat, please contact Antony Clark at RBW Consulting on +44 (0)1293 584300 or email antony.clark@rbwconsulting.com for full details.

 

 

 

 

 

Apply for this job: Process Design CMC Manager - Biotechnology

Contact Information:

Address:  Head Office
Origin Two 106 High Street, Crawley RH10 1BF
RH10 1BF
England
Tel:  01293 584 300
Fax:  01293 534 133
Website:  Visit Our Web Site

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