Senior Leader- Analytical Sciences

Biosimilar Sciences PR LLC

4d•Onsite

About The Position

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies. OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow. We are seeking an accomplished Senior Leader – Analytical Sciences to provide strategic and operational leadership across analytical development, technology transfer, and commercial GMP testing for biologics and biosimilars. This role is critical to supporting global regulatory filings, commercial manufacturing, and lifecycle management programs. The ideal candidate will bring deep expertise in analytical sciences, proven leadership within a reputed CDMO, and extensive experience interacting with global regulatory agencies.

Requirements

PhD or Master’s degree in Analytical Chemistry, Biochemistry, Biotechnology, Microbiology, or a related scientific discipline (PhD strongly preferred).
Minimum 20 years of overall industry experience, with at least 5 years in a top-tier leadership role within a reputed CDMO or biopharmaceutical organization.
Extensive hands-on and leadership experience in: Analytical Development and GMP commercial testing Tech transfer for biologics and biosimilars Global regulatory submissions and post-approval support
Proven exposure to and successful management of US FDA, EMA, Health Canada, and other global regulatory inspections.
Strong technical expertise in HPLC, cell-based assays, and microbiological assays.
Demonstrated experience with biosimilar analytical characterization and similarity assessment is highly desirable.
Deep understanding of ICH, FDA, EMA, and global regulatory guidelines relevant to analytical sciences.
Excellent leadership, communication, and stakeholder management skills.
Ability and willingness to relocate to Aguadilla, Puerto Rico, and work full-time on site.
Proven ability to operate effectively across multicultural teams and multiple time zones.

Nice To Haves

Demonstrated experience with biosimilar analytical characterization and similarity assessment is highly desirable.

Responsibilities

Provide strategic leadership for Analytical Sciences across development, tech transfer, validation, and commercial testing activities for biologics, biosimilars, and peptides.
Lead and oversee analytical method development, qualification, validation, and lifecycle management in a GMP environment.
Drive technology transfer of analytical methods from development to commercial manufacturing sites, ensuring robustness and regulatory compliance.
Ensure readiness and support for regulatory inspections and audits by US FDA, EMA, Health Canada, and other global agencies.
Oversee commercial release and stability testing in compliance with global regulatory expectations.
Provide technical oversight for advanced analytical techniques, including but not limited to: HPLC and related chromatographic methods Cell-based bioassays and potency assays Microbiology and sterility-related assays
Lead biosimilar characterization programs, including analytical similarity assessments covering: Primary structure (e.g., amino acid sequence, post-translational modifications) Secondary structure Tertiary and higher-order structure
Collaborate cross-functionally with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.
Build, mentor, and lead high-performing global analytical teams across diverse cultures and time zones.
Support global client interactions and act as a scientific and regulatory thought leader for analytical sciences.