Required Skills:

• Bachelor's degree minimum, with a degree in Engineering or Science and Business is preferred - Not tied to degree as much, more experience.
• No less than 5-7 years' of strong experience with a Pharmaceutical packaging background and Packaging equipment knowledge.
• Strong experience with the following:
  • Pharmaceutical manufacturing (operations, quality, technology/technical, supply chain) roles with a significant portion in management, team leadership, influencing skills, communication to drive business outcomes & cross functional team engagement. Lastly, Strong Project Management skills

• SAP, Microsoft Office, use of an MRP/ERP system not super tech savvy.
• Supply chain knowledge, knowledge of MSAT (manufacturing, science & technology).
• Experience leading large teams in led large teams in ops space.
• Experience managing third party suppliers or experience having worked in an external supplier management firm.
• Compliance Deep understanding of GMP and EHS compliance and compliance risk
• World Class Supplier Mindset proven Lean Six Sigma skills
• Business & Financial Acumen
• Titles incumbent may have held in the past: Operations Supervisor/Area Head, Manufacturing Area Director, Supply Chain Lead, Project Manager Operations, Packaging Equipment Designer
• Seeking a very collaborative forward thinking, leader!
• Organized, self-driven, multi-tasker by nature.
• Lead by example and your communication demands attention.
• Motivated, grounded and not easily overwhelmed.
• Focused and strategic.
• Thrive in fast-paced environments and have no problem adapting to your surroundings.
• Extremely detail-oriented and you have great, new ideas to share.
• Have top-notch interpersonal skills; an expert with creating trust and building/maintaining lasting relationships.

Project Description:
The External Manufacturing (ExM) Operations Manager will support the ExM Operations Director in satisfying customer demand to the External Manufacturing Partners. The incumbent will manage the process by achieving Compliance, Supply, Continuous Improvement & Cost; working as part of responsible, cross functional teams and in partnership with external partners. This role will have 2 main functions; 1- As an External manufacturing lead which will manage the relationship between external manufacturing partners. They will work with partners to review batches, resolve issues (delayed shipments, etc.), analyze supply impacts, determine if customer will receive shipment. The other piece is project management; Managing new, incoming external manufacturing product projects such as looking for & vetting new suppliers to build new relationships with. The resource will be working with the Client's oversight on this piece.

• Supporting the ExM Virtual Plant Manager (VPM), overseeing our company's relationship with the contract manufacturer. The VPM serves as the air traffic controller of all information/interactions between the Client's Manufacturing Division and the contract manufacturer and establishes boundaries and rules of engagement.
• As required, resource will engage with cross functional team (Supply Chain, Quality, Technical Operations, Planning) & will be responsible for delivering daily/weekly/monthly/annual requirements to their external partner(s).
• Responsible for operational related activities as delegated by the VPM:
  • Compliance (Quality Risk management, Deviation Management, Product Release, Change Control)
  • Meeting Demand
  • Production Planning
  • Materials Management (MRP entries)
  • Logistics including shipping of product to the downstream location
  • Technology issues
  • Oversight of shop floor production
  • Linking end to end (upstream and downstream) and with Supply Chain Management to ensure optimal flow of materials
  • Represent the VPM in forums as delegated by the VPM

• Routine presence at external partners site on the production floor. Building a strong relationship with the site team and able to assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site. Formulate the partnership with the external partner and the MSD cross-functional team action-orientated and time-bound improvement plans.
• Resource will work with the MSD team and external partner to understand current/future capacity based on agreed improvements
• Responsible for maintaining the integrity of the MSA (Master Supply Agreement), ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon are executed, including purchase orders, forecasts, deliveries, and approving invoice payments.
• Responsible for inventory control. Depending on the location of goods (at External Party or at the Client), He/She ensures adequate documentation of material disposition.
• Supports periodic Business and Operations Review Meetings and the annual Plan for the relationship with clear goals and targets, and annual "state of the union presentation for the relationships s/he manages which includes successes and failures in order to leverage across ExM.
• Strategically supporting the VPM's plans.
• Understands broad CMO business environment, specific opportunities & potential partners and their operations area
• Specific to Commercialization of new or existing
• Responsible for ensuring fulfillment of operations activities related to commercialization, new product introduction and commercial supply of pediatric and spray dried intermediate products.
• Ensure commercial item code creation
• Ensure shipping lane set up and qualification of product in the shipping lane
• BOMs or Bill of Materials
• Ensure Product standard cost set up
• Cold chain management system setup at external partner
• Understand product importation/exportation requirements
• Operations support for Product PPQs
• Operations support for packaging and artwork
• Is a delegate for the VPM as required
• Fully Remote 25% travel - May travel to a US Site This role may require time at the manufacturing and partner sites to ensure ongoing success, spanning Western Europe and the US

This 23+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: [ Link removed ] - Click here to apply to External Manufacturing (ExM) Operations Manager Pharmaceutical Packaging

ALPHA'S REQUIREMENT #21-00700
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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