Senior Manager Clinical Supply Chain

Sr. Manager Clinical Supply Chain

Contract Position

Location: Remote

Scientific Search has recently partnered with an exciting publicly traded biopharmaceutical company that is gearing up for their first approval and is searching for a Contract Sr. Manager of Clinical Supplies.

Responsibilities

• Perform necessary audits (remote and in-person) for packaging, labeling, storage, and other relevant logistics operations across sites in US, EU and other markets
• Serve as person in plant (PIP) for necessary GMP operations across sites in US, EU, and other markets
• Review and approve label text, specifications, proofs, batch records, packaging, and distribution instructions for clinical products
• Manage clinical supplies, leverage, and improve existing distribution (both control room and cold chain) network, coordinate shipment of GMP supplies to clinical sites in US, EU, and other markets
• Oversee and adapt towards necessary processes technology transfers as supply chain evolves from clinical to commercial partners
• Contribute to the development of phase appropriate control strategies, out of specification and out of trend investigations and implementation of relevant supply chain improvements
• Collaborate with QA to establish quality agreements, audit reports, develop specifications, investigate deviations, and implementation of CAPAs
• Ensure internal and external compliance with quality and regulatory in support of robust supply chain operations at the vendors
• Author sections of the CMC modules in support of regulatory submissions
  
  

Requirements

• BS/MS/PhD in biochemistry, biochemical engineering, pharmaceutical sciences or equivalent.
• 5 to 8 years of experience in developing supply chain operations towards labeling, packaging, kitting, and distribution of GMP supplies to clinical sites.
• Proven experience in developing supply chain strategies, management and forecasting of clinical supplies, budget planning, outsourcing, raw material qualifications, release of packaged GMP drug products and successful delivery to clinical sites
• Must be well versed with global import/export requirements and guidance documents (FDA/EMA/ICH)
• Exposure to GMPs and GDPs of clinical and commercial products
  
  

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.