Manager, Supply Chain

Act as the liaison between Synta Pharmaceuticals and third-party Clinical Services Organizations ( CSOs ) to effectively manage the labeling, packaging and distribution activities for all Synta Clinical Trials. Perform defined functions related to Synta's Drug Product Clinical Trial Material (CTM) manufacturing at third party Contract Manufacturing Organizations ( CMOs ).

Responsibilities:



Schedule CSO to perform labeling, packaging and on-time distribution of GMP CTM supplies to clinical sites in the US and abroad to meet clinical supply and delivery requirements

Manage GMP API and Drug Product inventories at CSO to ensure sufficient supplies are available to support internal product development and clinical supply demands

Provide effective and timely communication (inventory levels, documentation status, shipping status, etc.) to internal Clinical personnel, whilst maintaining all necessary blinding requirements per the clinical trial

Coordinate with Clinical personnel to determine an annual labeling, packaging and distribution budget for active clinical trials; maintain compliance with this budget and communicate variances internally as soon as possible

Establish measures and metrics to define supply chain performance and provide recommendations to management to optimize operations both internally and externally relating to clinical supply services

Identify, evaluate and recommend suitable CMOs for drug product manufacturing requirements

Collaborate and coordinate with the Drug Product Formulation Development group to successfully tech transfer manufacturing technology to selected CMOs

Manage identified CMOs in the drug product supply chain to ensure on-time performance delivery, quality products and budget compliance per Synta's requirements

Oversee manufacturing of cGMP CTM batches for Phase 1 through Phase development products, supervising each manufacturing operation performed by the designated CMOs during production to ensure compliance with approved manufacturing batch record procedures, applicable guidelines and regulations and cGMP's

Qualifications:



Bachelors or post-graduate degree in Science, business or related area and 7+ years of industrial experience in a Pharmaceutical or Biological manufacturing company

Phase 1 through Phase 3 clinical labeling, packaging and distribution experience managing a third-party CSO

Good understanding of formulation development and GMP manufacturing aspects of various dosage formulations ( injectables, solid oral, etc.) for Clinical Phase 1 through late stage development products

Aseptic parenteral manufacturing experience is preferred

Process tech transfer to CMOs and proven project management experience in this role is a requirement

Proven experience in trouble-shooting manufacturing equipment and processes, including equipment evaluation, Design of Experiments (DOE) and validation requirements (D/I/O/PQ and Process Validation)

Demonstrated ability to work effectively with Process Development, Quality, Regulatory and Clinical Departments

Strong interpersonal communication, technical writing, decision-making and teamwork skills

Team player, results- and detail-oriented; ability to handle aggressive, no-contingency project timelines

Willingness to travel extensively within the US and abroad