Manager, Biopharmaceutical Development and Clinical Supply Chain
ArmaGen is developing antibody-enzyme fusion proteins that crosses the blood-brain-barrier to address unmet cognitive diseases in patients with serious rare genetic disorders. Our current portfolio includes programs in preclinical development up to phase 2 clinical development. To streamline CMC activities for our biotherapeutic drugs advancing into clinical development and towards commercial manufacturing, we are looking for a Manager, Biopharmaceutical Development and Clinical Supply Chain. While non-GMP work is conducted within ArmaGen, we partner with CMOs and CROs for cGMP clinical supply manufacturing.
As incumbant of this position, you will closely interact with our internal development group and external partners for therapeutic protein production and manufacturing campaigns to generate antibody fusion protein drug candidates for Armagen’s 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 located in Calabasas.
- 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 our internal development work and work performed by our 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.
ArmaGen is a privately held, clinical stage biotechnology company focused on developing revolutionary therapies for severe neurological disorders. ArmaGen’s platform allows it to deliver biologics and other drugs across the blood brain barrier. The company is advancing innovative therapies for the treatment of currently unaddressed neurological complications of lysosomal storage disorders, as well as neurodegenerative diseases such as Alzheimer’s and Parkinson’s. The company’s lead product candidates are AGT-182 for Hunter syndrome, which is in Phase 1 clinical trials, and AGT-181 for Hurler syndrome, which is in Phase 2 trials. ArmaGen’s headquarters and research operations are located in Calabasas, California, near Los Angeles.
Competitive salary, stock options and benefits are provided for the successful candidate. Please submit resume and cover letter to Shawna Nagler at email@example.com.