Director of Clinical Operations

Description

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development with a focus on cGMP 1994 we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies 2004 we opened our peptide production facility in Menlo Park CA and in 2014 we expanded our production capability through the addition of a new state of the art building dedicated to cGMP peptide 2017 we passed a FDA inspection and were recommended to be approved for commercial drug substance 2023 we added additional cGMP clinical production capacity in Milpitas 2025 we are expanding to Montana as a result of SB535.

We need a driven operator to own the steps immediately before manufacturing (biopsy sequencing HLA / neoantigen selection patient ID) and after manufacturing (site readiness patient monitoring experimental treatment center setup pharmacy / compounding coordination and concierge services) while keeping the program inspectionready.

What youll do

A)Premanufacturing orchestration (biopsy sequencing patient ID)

• Stand up the biopsy tissue pipeline with hospital partners; own chainofidentity & chainofcustody from tissue acquisition to sequencing and epitope selection; implement standard labeling (e.g. ISBT128 CoI) and sample tracking.
• Contract and manage CLIAcertified sequencing labs (or inhouse partners) for tumor / normal WES / WGS RNAseq and HLA typing; enforce SLAs and QCs.
• Drive the neoantigen calling workflow with bioinformatics (variant calling HLA binding prediction ranking) and handoff to manufacturing slotting.
• Ensure proper consent / eConsent language covering tumor sequencing data use and recontact; keep Part11 and FDA esystems guidance in mind for EDC / eTMF / eConsent.

B)Manufacturing interface

C)Postmanufacturing clinical execution

and USP

(if hazardous components) and ensure California 503B license coverage when work occurs instate or across state lines.

D)Program build & reporting

Requirements

You might be a fit if

Nicetohaves

).

Benefits

Required Experience :

Director

Key Skills

Risk Management,Negiotiation,Operational management,Smartsheets,Strategic Planning,Team Management,Budgeting,Leadership Experience,Program Development,Supervising Experience,Financial Planning

Employment Type : Full-Time

Experience : years

Vacancy : 1