Clinical Supplies Associate, CMC

COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 4,000 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA (North America HQ), contributes important ophthalmic research & development and commercialization efforts, and is home to our regional business teams. This office currently employs about 140 people with large growth plans. Santen employs over 300 people in North America including our Ontario, Canada office and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Clinical Supplies Associate, CMC (Chemistry, Manufacturing, and Controls) position for Pharmaceutical Development Operations group is a permanent position, responsible for clinical supply preparation, logistics coordination, and inventory maintenance as well as document review and archiving of GMP and GCP clinical supply documentation.This is a critical role in assuring smooth clinical supply to allow completion of clinical studies in the US. This position requires interacting with different internal functional groups (e.g., Clinical Operations, QA, Regulatory, Project Management) and external vendors (CMO, drug depot, courier, customs broker, etc.), to support various drug development clinical studies. This is an integral US based R&D role in Process Development and Transfer group, under Pharmaceutics and Pharmacology Department, Product Development Division.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Participate in clinical study planning meeting to understand supply requirements and provide feedback on clinical supply design and quantities; provide updates at clinical study team meetings.
• Preparation of label text, kit list specifications, packaging design, in conjunction with clinical operations, and work with labeler-packager CMO.
• Review and approval of essential GXP documents such Master Batch Records, Dispensing/Distribution Protocols, Shipment Forms, IMP Manual and related forms.
• Coordination of labeling and packaging of clinical supplies that meet clinical study design requirements and timelines. Provide support for bulk shipment logistics, inventory tracking and accountability, temperature excursions, manual shipment requests, resupply and relabeling activities.
• Provide clinical supplies feedback on IRT database set up and UAT, maintain study parameters in IRT system, and provide support for Data Management.
• Summarize investigational product labeling text required for IND Module 1. Review clinical study supplies related information in clinical protocol, IB, and Quality Section of IND.
• Review clinical and registration drug product batch records, and as needed tabulate process parameters data to create batch information summary. Assist in review and compilation of required documentation that support drug development studies, regulatory submissions, and preapproval inspections.
• Organize and archive GMP documents related to PD/ CMC studies in Document Control Room and GCP artifacts related to investigational product in Trial Master File.
• Perform other CMC/PD and clinical supplies logistics support functions as needed.

QUALIFICATIONS:

Core competencies, education, and experience.

• Excellent communication skills, can collaborate smoothly with other functional groups and vendors, customer-focused value creation.
• Bachelors degree required, science related preferred.
• 1-3 years experience in pharmaceutical/ biotechnology/ life science industry or other manufacturing area, such as clinical supply labeling and packaging coordination.
• GMP/GCP background required.
• Experience and familiarity in use of documentation database and IRT systems (e.g., Veeva Vault, Medidata RAVE RTSM, etc.).
• Proficiency in MS Office Suite, including Excel and Project.

For more information about our company and the work experience, please visit www.santenusa.com.