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Job Details

CMC Manager

Company: Clinical Professionals Ltd
Location:
Reference: JO-1810-418402
Closing Date: 29 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Our client is an international pharmaceutical company who specialise in the fields of oncology, nephrology, immunology & CNS.

Requirements:

Our client is an international pharmaceutical company who specialise in the fields of oncology, nephrology, immunology & CNS. They're looking for an experienced CMC Manager to join their international Headquarters in Scotland to lead all CMC related functions for a variety of projects, including pre-formulation, formulation, analytical & process development, clinical manufacturing & packaging, scale-up, tech transfer, validation, launch & post-market support.

Key Responsibilities:

- Interact with third party manufacturers to provide technical support during process development, scale-up, technology transfer and commercialisation.
- Serve as the primary contact for licensed business partners to address any CMC issues.
- Provided technical and strategic guidance to Project Management, Quality, Regulatory and Manufacturing, in supporting development and launch of projects.
- Author or assist in the production of regulatory CMC documentation required by global regulatory agencies for submissions.
- Independently identify, prevent and solve technical problems.
- Participate in budget planning and financial assessments.

Requirements

- BSc/MSc in Chemical Engineering, Chemistry, Pharmacy or within a related scientific field or Ph.D.
- Hands-on experience within the pharmaceutical/biotech or allied industry in a manufacturing/QA/regulatory role.
- Familiarity with cGMP (EU and USA), DEA, and FDA regulations and SUPAC and ICH guidelines.
- An understanding of various dosage forms and experience with commercial pharmaceutical manufacturing processes and equipment.
- Experience working with CMOs, vendors and suppliers and maintaining successful partnerships.
- Experience with submissions/filings for EU and USA.

Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: matt@scientificprofessionals.com . We endeavor to come back to you within 24 hours of CV submission.

Apply for this job: CMC Manager

Contact Information:

Address:  Clinical Professionals Ltd
33 Blagrave Street,
Reading
RG1 1PW
England
Tel:  0118 959 4990
Fax:  0118 956 0607
Website:  Visit Our Web Site

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