Senior Analytical Sciences Leader – Biologics & Biosimilars

OcyonBio, LLC

Aguadilla (PR)

On-site

USD 180,000 - 240,000

Full time

11 days ago

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Benefits offered by this job

Health, dental, and vision benefits

Professional training and development

Stock options program

Job summary

OcyonBio, LLC in Aguadilla, PR seeks a Senior Leader – Analytical (Tech) Lead to drive analytical sciences strategy and tech transfer for biologics and biosimilars. You will lead cross-functional teams across development, transfer, validation, and regulatory-facing activities to support global filings and commercial manufacture.

The role requires deep analytical expertise, leadership in a CDMO environment, and collaboration with global regulatory agencies.

Qualifications

Must hold a Bachelor's or Master’s in a relevant science field; PhD preferred.
Minimum 20 years of industry experience with 5+ years in a top-tier leadership role.
Extensive hands-on and leadership in analytical development and GMP testing.
Experience with regulatory inspections by major global agencies.

Responsibilities

Provide strategic leadership for analytical sciences across development and commercial testing.
Lead method development, qualification, validation, and lifecycle management.
Oversee technology transfer from development to manufacturing with regulatory focus.
Ensure readiness for FDA/EMA/Health Canada inspections and audits.
Oversee release and stability testing in line with global regulations.
Guide advanced analytical techniques including HPLC and bioassays.