Director, External Supply Operations
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Director, External Supply role is responsible for developing new and improving existing systems and processes to manage our Medical Device Business Unit. This is a highly visible hands-on position that will have sole responsibility for managing all aspects of Emergent’s external manufacturing partners to deliver uninterrupted supply and total cost effectiveness. Works closely with Quality, R & D. Technical Operations, Regulatory Affairs, and Sales Operations deliver on our commitments and exceed Customer expectations while upholding Emergent’s high level of customer service, compliance adherence and product requirements. Using Operational Excellence principles, develops strategic plans to improve productivity, quality, and efficiency of operations. Delivers on Global Supply Chains core value proposition of Spend Value, Efficiency and De-Risking of the end-to-end supply chain
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Serve as the primary business contact with external manufacturing partners both domestic and international for Emergent’s Auto Injector manufacturing, sterile fill/finish & assembly operations.
• Manage supplier relationships, interfacing with site and corporate positions within the organization including C-level
• Develop and implement supply chain system solutions for external manufacturing operations that are compliant and cost effective
• Ensure that manufacturing is optimized, manage expiry of materials and minimize obsolete inventory risk.
• Direct and analyze all elements of the supply chain and make recommendations as to how the process can be optimized
• Provide cost savings recommendations and ensure spend is within budget
• With assistance from Finance, provide quarterly updates on COGS for products within the BU’s
• Accountable for Department Cost Center performance.
• Lead or assist with Global supply chain projects and initiatives as required.
• Works collaboratively with key stakeholders across the organization to determine business process owner(s) and/or subject area ownership, establishes organizational accountability, policies, standards and procedures with respect to all aspects of the External Manufacturing business
• Provide assistance with capital projects involving modifications at external manufacturers for new capabilities and manufacturing improvements
• Seek input to provide recommendations and formulate action plans for open issues based on industry best practices and hold issue owners accountable to hitting delivery targets
• Track, monitor, and report performance metrics related to operations, quality, cost, and customer service
• Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones
• Coordinate efficient implementation of product/process changes at contract sites and efficient coordination between external manufacturers and Project Management / Product Development
• Represent business at S&OP meeting providing supply analysis, options, mitigations and recommendations to address any supply chain gaps within the portfolio
• Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect performance goals
• Position will develop business continuity plans as a means to insure continued uninterrupted supply and develop supply market knowledge within key processing technologies, defines opportunities for leveraging across the supply base within
• Manage 3PL and external warehouse activities to support customer and business demands
• Demonstrate strong business acumen to understand the customers’ needs and formulate effective solutions
• Uphold Emergent’s core values, commitment to quality and corporate responsibility
• Advance EBS’s strategic areas of focus while ensuring a continuous, equivalent focus on “One Operations” key areas including leadership / employee development, advancement of best in class business processes, operational excellence, financial discipline / data driven decision making and quality / compliance.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s Degree in Supply Chain or Operations Management
• 8-10 years of related experience within medical device, combination drug device, biotechnology, pharmaceutical, or contract manufacturing industry required
• Minimum 5 years of Management experience
• Ability to work within a matrixed organization
• Multiple disciplines in CMO management, aseptic fill operations under cGMP manufacturing, distribution both domestic and international
• Working knowledge of International distribution regulations and requirements including but not limited to controlled substances, customs documentation, import / export VAT and tax considerations etc.
• Serialization knowledge DSCSA & EU FMD preferred
• Solid understanding of US and European regulations including application in the day-to-day environment
• Demonstrated strengths in relationship management that results in optimum service and performance
• Effective communicator with strong leadership and interpersonal skills
• Excellent analytical problem-solving skills
• Strategic and tactical thinking
• Ability to collaborate with internal and external partners at multiple levels.
• Ability to manage, prioritize and work cross functionally to influence behaviors and gain consensus
• Experience with developing and maintaining department budgets
• Experience in Lean principles and concepts
• Hands on experience with SAP preferred
• APCIS Certification preferred
• Skills in a second language German or French beneficial
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.