Head of CMC

Compensation

: $96,900.00 - $143,000.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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ABOUT UNITED NEUROSCIENCE: United Neuroscience (UNS) is a clinical-stage biotech company dedicated to the development of innovative therapeutics using proprietary vaccine technology. We are a multinational corporation with operations in the US (New York, Dallas and remote), Dublin, and Taiwan. We intend to become a leading developer of vaccines for neurological and other diseases by developing an innovative portfolio of therapeutics based on proprietary technology platforms. JOB SUMMARY: We?re searching for a Head of CMC with a strong technical skill set and excellent communication and organization skills. Candidate could have 10-15 years regulatory experience within biotechnology and/or pharmaceutical industries. ? ACCOUNTABILITIES: ?????????????????????????????????????????? Act as daily contact for UNS? CMC work conducted in Hauppauge (non-GMP tox manufacture, stability testing, analytical development) Oversee UNS? CMC work and prepare CMC development plans for products to progress Phase 1 to 3 Provide expert technical CMC input in one or more specialist area Oversee process and analytical transfer from UBI to UBIA / UBIP ? ability and willingness to travel to Taiwan regularly Prepare timelines of CMC activities REQUIREMENTS: Education: ???????Minimum BS.?MS or PhD preferred Experience:? Phase 1 to Phase 3; Phase 3 to commercial an advantage Peptide synthesis and analysis Peptide / subunit vaccine formulations in adjuvants, e.g. aluminium based, water in oil, oil in water Analytical development, qualification, validation to support Phase 1 to Phase 3 supply; Phase 3 to commercial an advantage Process development, characterisation, validation to support Phase 1 to Phase 3 supply; Phase 3 to commercial an advantage Raw materials supply Operating in a GMP environment ? Production, QA/QC Stability testing Analytical and process transfer (from non-GMP development to GMP production) Project management skills Comfort with international travel on a regular basis, likely quarterly To Apply: Please send an email to ...@unitedneuroscience.com with your resume and tell us in a paragraph why you?re interested and why you would be great for this role.
Associated topics: biomedical, drug development, immunohematology, immunology, microbiological, nutritionist, pharmaceutical, pharmacy, physiologist, transfection * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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