Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.
As a key member of the Device Manufacturing Operations Team, the Associate Director, Device Manufacturing is responsible for implementing the vision and strategic goals for all the cGMP device manufacturing activities including, but not limited to, product management of the production department and the transfer of products from R&D into production to ensure smooth continuous support of product forecasted needs, quality of the devices and compliance with current regulations and QMS standards.
This position interacts with internal and external customers and with all levels of personnel within and outside the company. The position is responsible for leading groups which include manufacturing and manufacturing engineering.
Essential job functions and duties
- Lead a cross functional team responsible for achieving Device Manufacturing operational, strategic and quality objectives, plans, and performance goals.
- Recruit, develop, mentor and retain high performing employees; provide timely feedback and manage performance challenges.
- Liaise between Clinical, R&D, Manufacturing and External Customers in support of device clinical product needs.
- Establish and track, monitor, and report continuous improvement metrics related to operations, quality and projects. Develop and distribute periodic reports on manufacturing and product servicing performance, issues, risks, and schedules of key activities, events, or milestones.
- Establish and maintain strong working relationships with suppliers, consultants and business partnerships ensuring adherence to contractual agreements.
- Develop, recommend and/or implement state-of-the-art manufacturing processes, methodologies and continuous improvements to the manufacturing process.
- Develop, monitor, manage and report on budget (capital and expense) for Manufacturing Operations.
- Administer and improve department practices and procedures according to regulatory and quality standards.
- Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect performance goals.
- Plan, monitor, and ensure that Device Manufacturing resources are adequate to achieve manufacturing goals.
- Approve documents and expenditures as authorized and described by Inovio policies, procedures, and job descriptions.
- Investigate, analyze, report, and track company and industry trends and apply lessons to technology at Inovio.
- Undergraduate degree in Life Sciences, Business Sciences or related scientific discipline required. Advanced degree (such as MBA) preferred.
- 8+ years of experience in manufacturing engineering and production with a minimum of 5+ years in the medical device/biotech/pharma industry
- 5+ years of experience managing direct reports
- Overall strong business knowledge of biotech/pharma/medical device manufacturing operations, product and process development, finance, and supply chain operations.
- Understanding of technology, regulatory and quality requirements, validation approaches, key risk areas and industry trends.
- In depth understanding of medical device manufacturing technics, methodologies and philosophies
- Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices.
- Experience in designing, managing and leading large technical programs and high-performing cross-functional and/or multi-cultural project teams and individuals, including experience designing, implementing, managing and improving business processes and/or leading operational excellence initiatives.
- Excellent communication skills with the ability to collaborate and work well with colleagues and internal/external customers
- Ability to travel domestically and internationally.
Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.
A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.