Specialist, Supply Chain Management

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.

JOB SUMMARY

External Manufacturing Specialist, Supply Chain provides oversight and day to day management of Emergent's Contract Manufacturing Organizations that support the Devices Business Unit ensuring adherence to quality systems, cGMP compliance, planned manufacturing targets and customer fulfilment requirements for current commercial segments along with supporting integration of new products into the portfolio. This position is located in Lansing, MI.

Essential Functions

• Point of contact for External Manufacturing activities in the Medical Devices Business Unit including scheduling, issue resolution, change management implementation, performance monitoring, supplier development, etc.
• Represent Supply Chain as a dedicated or support member on applicable Integrated Process Teams as needed.
• Ensure successful Performance Management process execution to drive consistency between Company and Department Goals and Objectives and Day-to-Day business operations.
• Work within approved quality system to oversee Change Management processes, Non-Conformances, CAPA and associated production related document revisions.
• Responsible for managing SAP Quality Notifications adhering to performance to plan metrics
• Maintain collaborative relationships with Manufacturing, Quality, Validation and Facilities Maintenance to assure the complete scope of planning activities remains connected with other tangential business operations and compliant with Quality requirements.
• Responsible for developing and maintaining effective communication tools, including weekly structured meetings and publicly available (e.g. intranet, Share Point) documents.
• Responsible for analyzing risk within the Supply Chain, developing mitigation plans and implementing Enterprise Risk Management solutions.
• Create and maintain data in SAP system in accordance with departmental procedures. Execute transactions to support supply chain operations.
• Compliance with Supply Chain Management responsibilities for Sarbanes Oxley process controls.
• Support Device Business Unit development projects serving as the commercial supply chain representative. Assist in creation of operational requirements and equipment selection.
• Support Global Supply Chain harmonization initiatives across Emergent sites.

Contract Manufacturing Organization Management:

• Responsible for monitoring External Manufacturer's Commercial Supply Agreements to ensure compliance with all applicable provisions for goods and service are maintained.
• Responsible for scheduling work at external partners in accordance with contract requirements, planned shutdown activities and quality performance to ensure uninterrupted flow of materials.
• Develop and report out on effective metrics, KPI's and monitoring programs to assure constant vigilance with respect to Supplier Performance. Establish jointly owned continuous improvement programs with suppliers.
• Responsible for systematic onboarding of new suppliers and the continued oversight of Supplier Development program including minimally one annual performance review.
• Responsible for SAP inventory transactions to ensure NLT 98% accuracy of all Emergent purchased materials located at External Manufacturers.
• Responsible for managing the coordination of customer deliveries while maintaining compliance with applicable export laws.
• Encourage implementation of Industry Best Practices for Supply Chain activities.
• Adherence to Company's Master Production and Delivery Schedule.

Culture Management:

• Collaborate with support departments to build effective teams through common understanding of Company goals, objectives, communication tools and committee structures.
• Live Emergent's core values and operate within a Culture of Accountability.
• Integrate Situational Leadership II principles and Performance Management into day to day tasks.
• Ability to effectively maintain a culture of continuous improvement is essential.

Compliance:

• Ensure maximum compliance with current Good Manufacturing Practices, Sarbanes Oxley and other areas of mandatory regulatory oversight.
• Initiate, route and complete applicable Quality Notifications including Deviations, CAPA's and Change Controls.
• Create / Revise Departmental Standard Operating Procedures.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

EDUCATION, EXPERIENCE, SKILLS

• Bachelor's Degree in Supply Chain, Operations Management, Biology, Biochemistry, Engineering or other related field.
• Minimum of 3 years of medical device or pharmaceutical industry experience required
• Experience in working in a cGMP Manufacturing environment.
• SAP experience preferred.
• Experience with 3rd party manufacturing preferred
• Experience with serialization systems adhering to DSCSA & EU FMD preferred.
• Prior Aseptic processing knowledge preferred.
• Plastic Injection molding experience preferred.
• Combination Drug Product experience preferred.
• Prior Supplier Development experience desired.
• Excellent written and oral communication abilities, able to present complex theoretical concepts and empirical performance data effectively in both oral and written formats, for audiences ranging from senior executives through entry level employees.
• Exhibit strong leadership skills, both with subordinates and peers, with particular emphasis on relationship development and implementation of company culture improvement initiatives.
• Must have continuous improvement mindset with strong LEAN principles and practices.
• Ability to manage both small and large projects with team-oriented focus.
• Excellent Analytical skills with a high attention to detail required.
• Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint, Visio).
• APICS or other accredited Supply Chain Certification preferred.
• International travel to External Partners required. Estimate 5-10% annually.

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

• 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 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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.