Executive Director & Head of Device Engineering

Employer:            Coherus Biosciences, Inc.                                        Ref #90828

Position: Executive Director & Head of Device Engineering

Duties:                  

Lead the Device Engineering Team in the development and commercialization of drug-device combination products for parenteral administration from discovery to transition to manufacturing. Lead characterization and development of device design and manufacturing processes, including managing the entire product lifecycle for a wide variety of drug delivery devices to support all therapeutic modalities in the pipeline. Work with device development team members, vendors, partners, consultants and external CMOs to ensure device development activities including development, verification, validation, risk management, and process validation are created and executed per device regulations and applicable standards for US distribution. Author, review, and approve device and combination product design control documents to support device development deliverables, including design inputs and outputs, design transfers, protocols, reports, risk management, and design validation. Lead and provide technical oversight over device manufacturing and combination product Contract Manufacturing Organizations (CMOs) to ensure successful clinical and commercial Good Manufacturing Practices (GMP) production of device constituents and drug-device combination products. Serve as the company device expert during regulatory agency interactions, partner audits, and inspections. Manage project budgets and device constituent purchasing controls and manage all contractor services spending.

Education:            Master’s degree or foreign equivalent in Biomedical Engineering, Biotechnology, or related field

Experience:          8 years of experience as Director, Vice President, Program Manager, Consultant, or related occupation.

Special Requirements: Must have at least 5 years of prior work experience in each of the following:

1. Drug device combination product leadership role managing key partner relationships including overseeing technical design & development activities, product & process characterization, product testing, and equipment & process validation activities.
2. Application of 21 CFR 820 in medical device development engineering activities including design verification, validation, risk management and process validation for development of drug delivery device combination products, through development & commercial supply lifecycle.
3. Leading the development and commercialization of combination biologic drug products in compliance with FDA and Ex-US health authority regulatory requirements, working with drug & process development teams to incorporate device design requirements driven by formulation and/or drug specifications.
4. Leading a team of device engineers for the development of device and combination product programs in compliance with 21 CFR 820, 21 CFR Part 4, ISO 13485, cGMP, ISO 14971, ISO 10993, ISO 62366 and ISO 11608 requirements (ISO standards are …