ProClinical is currently seeking a Biopharmaceutical and Clinical Supply Chain Manager for a privately held biotechnology company focused on developing groundbreaking therapies for severe neurological disorders. This biotech is currently developing antibody-enzyme fusion proteins that crosses the blood-brain-barrier to address unmet cognitive diseases in patients with serious rare genetic disorders. As incumbent of this position, you will closely interact with their internal development group and external partners for therapeutic protein production and manufacturing campaigns to generate antibody fusion protein drug candidates for the product development pipeline. You will direct CMC activities from pre-clinical studies through clinical development, commercial license application and launch. The candidate will have a strong interface with contract development and manufacturing organizations and will integrate internal process development procedures and external manufacturing operations. The scientific and technical background required for this position will have been gained from direct work experience in biopharmaceutical cell culture process development and manufacturing, and experience gained from serving in a process and product development team. This position is in Calabasas, California.
- Direct scheduling and providing oversight for CMO and CRO activities with respect to production of clinical and commercial drug substance and drug product supplies, physicochemical and biological testing, release and stability.
- Support selection and audit of contract laboratories and contract manufacturers.
- Manage tech transfers of analytical methods to contract testing labs and process transfers to contract manufacturers.
- Ensure proper execution of qualification and validation of analytical methods for process controls, product release and stability testing.
- Oversee process performance qualification and process validation execution.
- Coordinate internal process development activities with external contract partners.
- Fulfill the needs of the clinical supply chain function and ensure that clinical demands for drug supplies are fully met and all study patients are served without interruption globally.
- In partnership with clinical development, develop and maintain accurate forecasts for clinical supplies for on-going and new clinical trials.
- Ensure cGMP manufacturing schedules are met, release specifications and stability studies are established to support initiation and duration of clinical programs, and post-launch marketing.
- Arrange packaging, labeling and shipping of clinical supplies to investigation sites.
- Author CMC sections for IND and BLA filings and prepare requested response to regulatory agency questions to secure clinical investigation approval and commercial licensure.
- Serve as cross-functional coordinator of upstream, downstream, analytical and formulation activities for their internal development work and work performed by their external partners.
- Experience in antibody and/or fusion protein drug substance manufacturing, preferably using perfusion cell culture processes.
- Knowledge of drug product manufacturing including filling, packaging and labeling
- Experience in preparing CMC sections for IND and BLA regulatory submissions.
- Experience in reviewing production batch records for biologics drug substance manufacturing, fill and finishing operations.
- Preferably has served as process and product development team leader in the biopharmaceutical industry, coordinating multi-disciplinary activities for drug candidates in pre-clinical, clinical and commercial phases of development.
- MS with 10 + years or Ph.D. qualification with 7+ years in the biopharmaceutical industry.
- Excellent oral and written communication skills.
- Demonstrated strong collaborative and interpersonal skills and a high degree of personal integrity.
- Experience in facilitating cross-functional process development activities.
- Experience in matrix management.
- Must be hands on, detail oriented with a strategic outlook.
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 Herman Bradford on 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.