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Job Details

CMC Project Lead - Biologics/Biosimilars

Company: ProClinical Ltd
Location: Vaud
Reference: SC.CO.14764
Closing Date: 01 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global biotechnology leader, is seeking to hire a Senior CMC Project Lead.In this position, you will be managing CMC product development for several Biologic products going into and through clinical development stages.Role Responsibilities:• Manage CMC development for Biologics through clinical development• Coordinate with functional leads and external consultants to ensure timely execution of work packages. ...

Requirements:

Our client, a global biotechnology leader, is seeking to hire a Senior CMC Project Lead.
In this position, you will be managing CMC product development for several Biologic products going into and through clinical development stages.

Role Responsibilities:

• Manage CMC development for Biologics through clinical development
• Coordinate with functional leads and external consultants to ensure timely execution of work packages.
• Manage Biologic projects from development to IMP administration
• Act as point of contact for CMOs/CROs as well as external consultants
• Regularly liaise with CMC senior management and key stakeholders for strategy determination and to ensure appropriate communication.
• Manage all aspects of process technology transfer and scale up procedure to commercial scale for late stage clinical development Biologics products
• Execute RFP, CMO identification, technical/quality agreements in collaboration with QA.
• Responsible for the drafting and completion of regulatory submission documents working alongside functional/technical leads to assemble relevant sections.
• CMC lead for external due diligence activities.
• Manage project CMC budgets

Education, Skills and Experience:

* BSc, MSc, PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline
* Relevant biologics R&D and/or CMC experience in an Biotech industrial setting, experience in biosimilar development a plus
* Excellent planning, organizational and communication skills
* Familiarity with current GMP guidelines and some knowledge and/or exposure to regulatory requirements and submissions (IMPD/IND/BLA) and quality requirements from the industry (GMP; ICH)
* Practical experience or theoretical knowledge in process development, analytics, technology transfer, process scale up, process validation and/or GMP manufacturing in the Biotech industry would be a strong asset

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: CMC Project Lead - Biologics/Biosimilars

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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