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Process SME
JDPHI820805
We are looking for a passionate BDS Drug Manufacturing Process SME in our Philadelphia Operation who is driven by collaboration, exceeding expectations, and challenging the status quo. The Process Subject Matter Expert (SME) will serve as a top-level technical or functional expert; often working on multiple projects and programs that support one or more clients in the Pharmaceutical and Biotechnology industry, specifically, Bulk Drug Substance (BDS) manufacturing design including feasibility through to detailed design and construction / qualification. The role is a key leadership position in the Philadelphia Project Operations with ability to support other regions and countries as an SME.
Process SME JDPHI820805
Key responsibilities:
- • Active participation in Philadelphia Operations Leadership team, driving the growth, culture, and success of the office and projects.
- • Execute site master planning, concept designs and early preliminary engineering phases
- • Drive technical discussions and decisions based on cost, operability, schedule and technical suitability
- • Develop and maintain client relationships and have a strong drive to deliver to clients.
- • Analyz938127.607693es and performs highly specializ938127.607693ed technical tasks associated with cutting-edge technologies
- • Maintains current knowledge of relevant developments in their professional area of expertise
- • Develop and promote process technologies, recommend strategy, best practice methodologies and cost models
- • Work with clients to solve various problems associated with the project and will apply expert functional knowledge and experience to provide optimal project solutions
- • Prepare and participate in project proposals, man-hour estimating and client presentations
- • Participate in presentations at industry conferences and writing of papers in publications
- • Identify and research future industry trends. Keep on top of technology and industry developments
- • Support Business Development for client engagement at senior levels
Education & experience:
- • Bachelor of Engineering Degree. Bio/Chemical Engineering preferred
- • 15-20 years of relevant experience in engineering/design firm setting with a focus on Life Sciences
- • Operating facility and/or equipment technical specification/design experience essential
- • Active committee member of ISPE, PDA and/or other industry bodies.
- • Recogniz938127.607693ed globally by clients as a critical thinker, sought after by global clients to assist in technically complex problems
Essential skills:
- Excellent verbal and written communications skills
- Ability to deliver and support technical presentations to clients and staff.
- Experience working with Sales and Operational Leadership on new business proposals and proposal development.
- Experience leading the development of deliverable content that meets the needs of the client.
- Proven ability to author articles and to present at conferences and evidence of active participation in industry organiz938127.607693ations required.
- Expert working knowledge of critical unit operations including cell culture, fermentation, purification, novel therapies.
- Ability to inspire teams and set goals
- Positive attitude, even when under pressure
- Collaborative and productive work style
Other:
- Travel: 0 – 20% travel
- Working hours: 40 hours, Monday to Friday with flexible work environment
