Associate Principal Scientist Engineer, Drug and Device Combination Products (Onsite)

Job Description

The Associate Principal Scientist / Engineer of Method Development, Testing & Transfer will be responsible for helping to lead the Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor in support of development activities, IND-enabling stability, commercial stability, and Design Verification. This role involves leading the method development technical strategy across multiple products and programs, and defining the transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Principal Scientist / Engineer will be responsible for the management and technical development of a small team (4-5 scientist / engineers) responsible for providing routine functional testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization for our Company's rapidly expanding medical device and combination product (MDCP) portfolio.

Key Responsibilities:

• Technical (co)leadership of a Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV).
• Lead method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies.
• Lead, manage, and develop a team responsible for providing routine functional testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization.

• Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control (QC) facilities to ensure that functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System (QMS) compliance.
• Talent retention, training/upskilling, and recruiting of top talent as needed to deliver on pipeline and innovation projects.
• Ensure training, safety, and compliance requirements are met and roles and responsibilities are clearly understood and followed.
• Employee development and growth opportunities.

Qualifications:

• Advanced degree (PhD) preferred
• Demonstrated leadership experience in leading and managing teams, preferably in a regulated industry.
• Extensive knowledge of method development, validation, and transfer, with an understanding of regulatory requirements and industry best practices.
• Experience in collaborating with cross-functional teams including Quality, Regulatory, and QC facilities.
• Strong project management skills and the ability to prioritize and manage multiple projects effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

Required Education, Experience & Skills

• Bachelor's or Master's degree in Mechanical Engineering, Chemical Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or equivalent field.
• 7+ years of experience in method development, validation, and testing within the pharmaceutical, medical device, or combination product industry.

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Required Skills:

Analytical Chemistry, Chemical Biology, Collaborative Development, Combination Products, Design Failure Mode and Effect Analysis (DFMEA), GMP Compliance, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Medicinal Chemistry, Project Management, Project Management Support, Quality Control Management, Quality Management Systems (QMS), Test Method Validation

Preferred Skills:

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