Associate Principal Scientist leading CMC initiatives in a global biopharmaceutical company. Driving strategic planning and delivery of key transformation projects across cross - regional functions.
MS
Hybrid Senior Principal Scientist – Device Technical and Engineering Lead
Posted 3 months ago
About the role
- Lead device development strategies for biologic/drug/vaccine-device combination products with a focus on product and process development. Collaborate with cross-functional teams from concept through launch.
Responsibilities
- Apply their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs.
- Interact extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch.
- Ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements.
- Lead cross-functional development teams within and external to Device Development & Technology.
- Work well with all levels of employees and effectively coordinate the execution of device development strategies.
- Apply knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.
Requirements
- B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development.
- Advanced degree is preferred.
- 5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes.
- 5+ years of leadership experience of managing complex device or combination product development programs and leading cross-disciplinary project teams.
- Experience in development and commercialization of inhalation devices and/or autoinjectors is strongly preferred.
- Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy.
- Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.
- Proven track record of applying analytical skills in product design, development, and validation.
- Self-motivated with ability to work independently.
- Proven ability to lead team members of diverse skill sets and backgrounds.
- Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
- Excellent communication, presentation, negotiation, project management, and organizational skills.
- Experience with leading complex development projects at an enterprise level.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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