API Category Sourcing Specialist:
How will you make an impact?
The API (Active Pharmaceutical Ingredient) API Category Sourcing Specialist will report to the Senior Manager, Global Drugs and Pharmaceutical Products, and collaborate with Softgel, and all Drug Product Formulations Manufacturing sites to source mainly generic API for formulation at development, and commercial manufacturing stages. The scope of this role is to (i) Manage all API sourcing end to end management for the two Softgel Manufacturing sites (Tilburg and High Point); (ii) Sell the API sourcing capability in conjunction with Sales/Business Managers for the rest of formulation sites to grow the global Pharma Services Division Business.
What will you do?
- Drive the business acquisition of the API (Active Pharmaceutical Ingredients) Sourcing Services in conjunction with Sales/Business Management to support and enable the growth of the Pharma Services Division formulation business which includes both development and commercial projects.
- Understand the business requirements in terms of IP (Intellectual Property), API chemical and physical properties related to the critical quality attributes of the formulation product, technical (capacity, lead time, batch size), EHS (including DEA, High Potent), regulatory and documentation, logistic and license, and economic requirements.
- Manage all API Sourcing activities for Thermo Fisher’s drug product manufacturing sites globally.
- Apply the Thermo Fisher Sourcing Management Process to propose a robust sourcing strategy, evaluate the market place for the best suppliers, perform compliance (including financial solvency) due diligence, accompany QA, and EHS audits, assess all potential supplier value chain risks, leverage the preferred supplier network, and lead contract negotiation with Legal to secure the supply. Lead and coordinate all the expectation, communication, governance structure (including escalation, and deliver a solution to the any issues) with suppliers.
- Act as the liaison between the core project team and global and site support functions such as regulatory, EHS, legal, finance, procurement and supply chain.
- Provide continuous API Sourcing support throughout the lifecycle of projects including but not limited to sample requests, specification revisions, technical discussions, change controls, conflict resolution, relationship governance management.
- Identify, build, and maintain mutually beneficial relationships, partnerships, and alliances with select suppliers through Supplier Relationship Development programs
- Partner with Thermo Fisher legal representation to execute CDA/non-compete documents and Master API Supply Agreements.
- Lead engagement with business partners to influence business strategy leveraging supply market insights and align sourcing strategies
- Consolidate the global spend information on API. Perform spend analytics by supplier, regions, sites, and categories. Identify synergies and coordinate the global value capture opportunities for API, to track the implementation and realization to increase the product gross margin for Thermo Fisher.
- Devise and implement API risk mitigation strategies to ensure continuity of supply via alternate source and supply agreement pathways.
- Contribute to continuous improvement in sourcing processes, tools, and operating model.
- Act as a decision maker for API category/functional sourcing strategy and supplier selection.
- Drive operating efficiencies by understanding business needs and complex supply markets.
- Access supplier capability and innovation for the business.
- Represent the API Category through KPI (Key Performance Indicator) reporting to procurement leadership
How will you get here?
- Bachelor degree desired, high school diploma/GED is minimum requirement
- 5-7 years of experience in API or Raw Material Procurement, Supply Chain, Sourcing, or related experience required
- 5+ years’ experience in API Procurement related field (Procurement, Supply Chain, Sourcing, or related function).
Knowledge, Skills, Abilities
- Active Pharmaceutical Ingredient (API) sourcing category
- Controlled Substance Sourcing and Procurement in accordance with governing agencies
- Tailored API sourcing approach to specific drug product formulations and end market
- Procurement strategy creation and implementation
- Drug development lifecycle management
- Regulatory pathways for drug filing (NDA, ANDA, 505b2) as well as ICH and cGMP guidelines
- Supplier performance management framework
- Establishing business continuity plan through supply chain/logistics design
- Negotiation, conflict resolution and stakeholder management
- Leading global, cross-functional project teams
- Translating business objectives into procurement priorities.