The Associate Director (AD) of Biologics Device Development will provide technical evaluation and direction for the development and validation of combination products comprised of biologics with injectable devices. The AD will be responsible for manufacturing supplies of devices for preclinical and clinical studies and the successful execution of comprehensive technical and human factor studies required for regulatory approval of such combination products. The Associate Director position has accountability for technical decision-making and will be a major contributor to the writing of Design History Files, Human Factor Studies protocols, technical development reports, as well as global regulatory submissions. The AD will need to coordinate with external partners the completion of device design development and customization, combination product risk assessments including design failure mode and effects analysis (dFMEA, pFMEA, uFMEA), device design verification and qualification. The AD will be responsible for the timely coordination of all device development operations and manufacturing campaigns according project timelines, cost and available resources. The Associate Director will work with the Clinical, Quality, Regulatory, Supply Chain, otherinternal functions and external organizations to ensure that our combination products meet the highest standards for quality and supply and improve patients’ lives. This position reports to the Senior Director of Biologics Drug Product & Device Development.
- Provide technical leadership of biologics device development and validation in various stages of development. Oversee work flow, progress, and milestone achievements.
- Responsible for drug/device combination products development and validation, human factor studies, regulatory filings and combination products launch and post-launch support for biologics.
- Conduct risk assessment for various device development operations to support device design input and customization, device qualification and validation, device technical transfer, clinical manufacture and preparation for launch and commercialization.
- Spearhead operational excellence strategies to improve combination product quality, reliability and reduce risk.
- Lead computational fluid dynamics simulations, process modeling, data trending and advanced statistical analysis in various stages of combination products development.
- Design and manage appropriate development, stability and stressed studies, and organize analysis and reporting of data
- Ensure the compliance with applicable GMP, regulatory, ISO and other professional requirements for combination products during development, validation and manufacture.
- Responsible for CMC support of regulatory filings for combination product
Required Knowledge, Skills, and Abilities
- Experience in outsourcing, managing combination product /device development from Phase 1 to post-approval.
- Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task
- Proficiency managing contract combination product manufacturing for biologics as well as product technology transfer.
- Demonstrated proficiency in troubleshooting and problem solving and use of experimental design to elucidate effects of variables. Experience with computational fluid dynamics is desirable.
- Excellent written and verbal communication skills .
- Ability to collaborate with Global Manufacturing, Supply, Quality, Regulatory and other functions to ensure manufacturing processes are commercially viable and meet the standards of quality and supply.
- Design and manage appropriate stress and stability studies. Organize analysis and reporting of data
- Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
- This position requires proven abilities and skills in leadership, project management and working in cross-functional work teams.
Required/Preferred Education and Licenses
- Bachelors of Science, Master’s or Ph.D. degree in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field is required.
- At least 7 years of hands-on experience in combination products development and validation for biologics preferably in pharmaceutical or biotech company. Experience in outsourcing and strategic device development partners management is strongly preferred.
- The ideal candidate will have previous combination product project managementexperience from early feasibility to commercialization. Deep understanding of device related ISO standards and global regulatory requirements/guidance documents.
- Strong technical writing and oral communication skills are required. Experience preparing information for 510(k), BLA, IDE, and PMA submissions is a plus.
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
- Requirements associated with international and domestic business travel.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Periodic business meetings and trade shows requiring appropriate business apparel.