Role Description
(Multi-Level (Manger-Director)) Drug Product and Device Development reports to the Vice President, Product and Device Development and will provide broad-based support for the technical transfer and clinical manufacture of drug product at our Contract Manufacturing Organization (CMO) located in Europe and develop process in house.

Responsibilities

• Provide technical support of drug product process transfer and clinical manufacture of drug coating from late-stage development through commercialization
• Support Drug Product process characterization and process validation studies at external CMO
• Establish and implement phase-appropriate Drug Product development concepts and standards in a resource- and cost-effective manner
• Ensure high-quality vendor management, meeting company standards and industry regulations for biopharmaceutical products; serve as person in plant as needed during critical operations
• Provide scientific/engineering development support for drug coating and other subsequent projects at various stages of development
• Develop strategy and logistics for projects and technology transfers in support of process improvements and new product introductions
• Use sound scientific and engineering criteria to evaluate manufacturing processes, identify and execute process optimization strategies, and ensure successful manufacturing combo drug device.
• Execute programs and prepare documentation to support key regulatory milestones such as preparation and submission to regulatory authorities (US, EU, ROW), and fulfilment of post marketing commitments
• Provide both strategic and detailed engineering/technology support for development and pre-marketing production of drug device.
• Participate in CMC and cross-functional development teams, as required, including due diligence of potential acquisition candidates
• Establish internal capabilities for coating process.

Technical Requirements & Skills

• Experience in all aspects of drug product development, clinical manufacture, and drug delivery, in addition to helping manage external vendors and oversee outsourced activities
• Working knowledge of drug/medical device combination products and human factors studies
• Functional knowledge of formulation development and analytical techniques for the characterization of biopharmaceuticals
• Knowledge of international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• High proficiency in written, oral, and interpersonal communications in English, including with senior management, health authorities, and internal and external partners
• High attention to detail; ability to organize, prioritize, and delegate assigned projects
• Exceptional influencing, partnership, and collaboration skills
• Able to prospectively identify potential problems and to partner effectively and positively to solve issues
• Proficient use of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable
• Ability to self-start in a virtual organization, influence effectively in videoconference-based project team meetings, ability to engender shared commitment with CMO-CRO for delivering on agreed objectives

Qualifications

• 10 + years’ biotechnology industry experience with successful product launches and/or clinical validations.
• Broad hands-on exposure to drug delivery technologies and dosage forms including development and/or significant optimization/robustness of drug product formulations
• Working knowledge of CMC regulatory requirements for biopharmaceutical products in various stages of development as well as practical application of principles of quality by design (QbD)
• Direct relevant experience in drug product development and commercialization in US, EU, ROW
• Experience in drug coating transfer and scale up for GMP requirements of drug coated devices
• Experience outsourcing manufacturing/development activities at CMO/CROs
• Excellent oral and written communication skills
• Advanced degree (M.S./Ph.D.) in relevant scientific discipline, e.g. Chemical/Bio Engineering, Protein Chemistry, Biological Sciences, Pharmaceutical Sciences or equivalent industry experience.