Sr. Manager, Supply Chain, External Manufacturing Operations – Emergent BioSolutions – Lansing, MI, USA
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 Sr. Manager, Supply Chain/ External Supply Chain Operations role is responsible for developing new and improving existing systems and processes for external manufacturing operations. This is a highly visible hands on position that will have sole responsibility for managing all aspects of the external manufacturing partners to deliver uninterrupted supply and total cost effectiveness while upholding Emergent’s high level of customer service, compliance adherence and product requirements.
- Serve as the primary business contact with external manufacturing partners both domestic and international for Emergent’s Auto Injector manufacturing, fill/finish & assembly operations and sterile liquid fill / finish.
- Manage supplier relationships, interfacing with site and corporate positions within the organization including C-level
- Develop standard operating procedures, process documentation including process flows and SAP transaction instructions as needed to support the business.
- Develop and implement supply chain system solutions for external manufacturing operations that are compliant and cost effective
- Develop and manage to a master production plan in a complex supply chain environment.
- Ensure that manufacturing is optimized, manage expiry of materials and minimize obsolete inventory risk.
- Manage and negotiate contractual compliance and performance issues with external manufacturers
- 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.
- Lead or assist with supply chain projects and initiatives as required.
- Track project deliverables utilizing appropriate tools
- 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
- Provide technology transfer and manufacturing support:
- Manage planning and coordination of product transfer to the contract site(s)
- Develop budget, timeline and coordinate transfer team activities to achieve seamless product transfer to the contract site(s)
- Drive risk management as part of transfer.
- Lead site issue management and resolution; provide issue escalation to the right level
- Demonstrate strong business acumen to understand the customers’ needs and formulate effective solutions
- 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/demand 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 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
- Ensure risk assessments and appropriate risk mitigation plans are established for uninterrupted supply
- Coach and mentor staff to resolve conflicts and identify and mitigate risk.
- Uphold Emergent’s core values, commitment to quality and corporate responsibility.
Education, Experience & Skills
- Bachelor’s Degree in Supply Chain or Operations
- 8-10 years of related experience within the biotechnology, pharmaceutical, or contract manufacturing industry
- Minimum 5 years of Management experience
- Multiple disciplines in CMO management, aseptic fill operations under cGMP manufacturing, procurement, distribution both domestic and international.
- Solid understanding of US and European regulations including application in the day to day environment.
- Previous experience working with FDA and participating in regulatory agency inspections
- Experience with Medical Device preferred
- Demonstrated strengths in relationship management that results in optimum service and performance
- Prior hands on experience with SAP in purchasing, demand planning, production planning, warehouse management and sales & distribution
- Experience in working with and negotiating supply agreements and equipment contracts
- Skills in a second language German or French beneficial
- 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.
- Ability to manage and prioritize multiple tasks
- Desirable to have experience with developing and maintaining department budgets
- Working knowledge of International distribution regulations and requirements including but not limited to customs documentation, import / export VAT and tax considerations etc.
- Prior experience with ITAR regulations preferred
- Experience in Lean principles and concepts.
- APCIS Certification preferred
- Ability to travel both domestic and international (between 10-25%)
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, lift/carry 25 lbs, and pull 40 lbs. Use phone, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, in hot/cold temperatures, where ventilation is needed, in multiple locations, and in contact with Select Agents.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.