Principal Program/Project Manager - Injectable Device Engineer

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Check out the job we have available below!

Summary

This role will be an authority in injectable device development. Incumbent will lead device evaluation, process development, product integration, and manufacturing of patient-centered injectable drug products. A key focus area would be on the successful development of drug/device combination products for a client asset. The position will work with the department head to assess appropriate device/drug product development and delivery strategies via internal and external partnerships, handling the budget and internal resources for the development of clinical and commercial phase drug products. Enables the development of phase-appropriate regulatory strategies and products.

Responsibilities:

• Leads activities for the selection of an autoinjector device platform for a client asset, an injectable drug in development. Develops a strategy to evaluate and implement the chosen platform.
• Direct process development, product integration, and manufacturing of patient-centered, differentiated injectable drug products, with focus on a client asset.
• Progresses the development of a client asset for delivery via an autoinjector and prefilled syringe. Direct work at CDMO’s to evaluate the product in pre-filled syringes and to develop and evaluate product performance in an autoinjector.
• Participates in developing drug product development and delivery strategies through internal/external partnerships as well as product integration into drug/device combination products.
• Leads manufacture of prefilled syringe drug product and auto-injector assembly. Lead process characterization and process validation studies for late-stage programs to enable robust commercial manufacturing processes.
• Leads development of CMC strategy to implement PFS/Auto-injector in a late stage development program. Provide subject matter expertise for regulatory interactions including inspections, audits and is accountable for the technical content of drug product sections of regulatory submissions.
• Work on drug product development strategies with key collaborators in Research, Clinical Development, Regulatory Affairs, Quality, and Commercial organizations.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Knowledge, Skills and Abilities:

• Substantial years of injectable device development experience with 5+ years of experience leading device development for biologics.
• Experience in managing drug product and device development at external CDMO’s.
• Deep knowledge of development of autoinjector and pre-filled syringe drug-device combinations, biologics drug product manufacturing, aseptic processes, and knowledge of current regulatory guidelines and cGMP requirements is essential.
• Direct experience in preparing regulatory submissions including BLA/MAAs and engaging with regulatory inquiries is required.
• Experience in developing CMC strategy for development programs. Ability to manage timelines, budgets and integrated development plans.
• Intellectual agility - able to pivot based on shifting priorities and balance multiple projects seamlessly.
• Natural collaborator who enjoys working on a cross-functional team
• Demonstrated communication, problem-solving, and negotiation/decision-making skills

Working Environment:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.