Catapult Solutions Group is looking for a fulltime Supply Chain Manager (Associate Director) for a generic drug company. This is a remote position, but the Supply Chain Manager needs to be in the Eastern Time Zone.
The Supply Chain Manager (Associate Director) will be responsible for the supply chain network of both commercial and development stage products, including contract manufacturing, raw material suppliers, packaging vendors and cross-functional oversight of third-party logistics (3PL) vendors. The individual must have a strong understanding of systems validation to ensure that any packaging and labeling computerized systems (i.e. systems to support DSCSA and other regional requirements) are compliant with quality systems as well as how to manage integration of data with other CMOs.
· Contribute to product development by identifying high-quality raw materials that meet cGMP and budget requirements.
· Identify high-quality development (CDMO) and manufacturing (CMO) partners.
· Ensure that supplier, product distribution, and commercial supply agreements are established and ready to support product launches and ongoing supply.
· Identify alternate sources for all materials and facilitate their qualification.
· Coordinate and organize vendor audits as needed.
· Lead implementation of serialization activities for new and existing products.
· Identify serialization partner, establish serialization systems.
· Collaborate with external supply chain partners (CMOs, 3PLs, wholesalers, distributors, customers) for real time visibility to support serialization activities.
· Collaborate and participate with both internal and external project teams related to serialization and product security.
· Provide on-time manufacturing and delivery of trade and sample products to the 3PL distributor and sales reps, avoids product stock-outs, and ensure sufficient safety stock inventory.
· Lead and organize technical discussions with vendors and internal technical teams and facilitate exchange of documents between teams; evaluate and agree on long-term supply arrangements with suppliers where possible to ensure cost competitiveness in the market.
· Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply or distribution to the marketplace in the event of a supply chain disruption.
· Develop strategic business plans, supply chain continuity establishes necessary company infrastructure, procedures, policies and budgets required for the successful implementation of long-term supply chain strategy.
· Acts, as needed, to quickly implement corrective and preventive actions (CAPA) in the event of a manufacturing or distribution incident, serious adverse event, or recall.
· Manage or assist with other ad hoc projects as requested.
Skills & Requirements
· Track record in managing third-party manufacturing operations, logistics and supply chain functions in the pharmaceutical industry.
· Ability to travel domestically and internationally to contractor locations, as needed.
· Excellent negotiation, leadership, communication and interpersonal skills.
· Entrepreneurial mindset with the ability to function independently and work with cross-functional teams in a dynamic work environment.
· Experience with DSCSA requirements and TraceLink or similar platforms.
· Experience with cold chain product distribution preferred.
· Knowledge of innerworkings of a pharmaceutical warehouse distribution, or third party logistics (3PL) distribution, including exports and customs clearance.
· Knowledge of warehousing and distribution operations in a cGMP manufacturing environment.
· BS degree in supply chain, pharmaceutical sciences, or related field.
· 7+ years of experience in pharmaceutical product supply chain, vendor management, and distribution systems.