Job Posting Title

Senior Scientist - New Product Introduction (NPI)

Job Description

Place of Performance:
CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603.

Job Overview

OcyonBio is seeking a highly motivated Senior Scientist - New Product Introduction (NPI) to support the transfer, introduction, and lifecycle management of new biopharmaceutical products into GMP manufacturing operations. This role provides technical leadership for technology transfer activities, supports operational readiness, and collaborates cross-functionally to ensure successful scale-up and commercialization of manufacturing processes within a regulated environment.

The ideal candidate will have experience supporting drug product technology transfer activities, particularly in sterile or parenteral manufacturing operations, and will thrive in a fast-paced startup environment requiring both strategic thinking and hands-on execution.

Responsibilities

• Lead and support technology transfer activities for new products entering GMP manufacturing operations.
• Collaborate with Manufacturing, MSAT, Quality, Engineering, Supply Chain, and Validation teams to support successful product introductions.
• Support transfer and scale-up activities for aseptic filling, formulation, filtration, and related manufacturing processes.
• Provide technical support for drug substance process transfers and upstream/downstream operations as applicable.
• Author, review, and execute technical documents including protocols, reports, risk assessments, batch records, and SOPs.
• Support engineering runs, process validation, PPQ activities, and process performance monitoring.
• Evaluate process data, identify risks or gaps, and implement scientifically sound solutions.
• Support deviation investigations, root cause analysis, CAPA implementation, and change control activities.
• Assist in developing manufacturing processes and control strategies aligned with regulatory expectations and industry best practices.
• Support interactions with external partners, clients, and CDMOs during transfer and onboarding activities.
• Provide technical mentorship and scientific guidance to junior team members and cross-functional partners.
• Demonstrate flexibility and a hands-on, startup-oriented mindset to support evolving operational needs.

Experience and Education

• Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related scientific discipline required.
• Advanced degree preferred.
• Minimum 5 years of experience in GMP biopharmaceutical manufacturing, MSAT, process development, or technology transfer roles.
• Experience supporting technology transfer or new product introduction activities within regulated pharmaceutical or biotechnology environments.

Qualifications

• Strong understanding of GMP regulations, process documentation, and manufacturing operations.
• Experience authoring and reviewing technical and GMP documentation.
• Knowledge of process validation, PPQ, and lifecycle process verification principles preferred.
• Familiarity with risk management tools and structured problem-solving methodologies preferred.
• Experience supporting sterile, aseptic, or parenteral manufacturing operations preferred.
• Experience working with CDMOs, external manufacturing partners, or client-facing technical transfer activities preferred.
• Understanding of FDA cGMP regulations, ICH guidelines, and industry best practices related to tech transfer and manufacturing sciences.

Skills

• Strong analytical and problem-solving skills.
• Strong technical writing and documentation capabilities.
• Effective cross-functional communication and collaboration skills.
• Ability to manage multiple priorities in a fast-paced startup environment.
• Ability to balance strategic thinking with hands-on execution.

Working Conditions

• Work performed in GMP manufacturing and office environments.
• Periodic presence in classified cleanroom and manufacturing areas may be required.
• Use of required PPE and gowning procedures in controlled environments.
• Flexibility to support extended hours during transfer activities, validation runs, or operational startup efforts.

What We Offer
• Competitive salary (DOE)
• Health, dental, and vision benefits
• Professional training and development opportunities
• Participation in company stock options program

If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare.

To learn more about us, please visit our website: https://ocyonbio.com