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Supply Chain Specialist, Fill Operations

Company: Emergent Biosolutions
Location: Lansing
Posted on: November 23, 2022

Job Description:





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 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.



ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.



General Responsibilities:

* Primary point of contact for External Manufacturing regarding, change management, performance monitoring, supplier development, purchase parts inventory and production documentation.

* Represent Supply Chain as a dedicated or support member on applicable Integrated Process Teams as needed.

* Facilitates the CMO Integrated Process Teams meetings and maintains key data relative to CMO performance and KPI monitoring

* Ensure successful Performance Management process execution to drive consistency between Company and Department Goals and Objectives and Day-to-Day business operations.

* Work within the approved quality system to oversee Change Management processes, Non-Conformances, CAPAs and associated production related document revisions.

* Responsible for developing and maintenance of 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

* Collaborate with External Manufacturing Partners in assessing equipment reliability to ensure uninterrupted supply and develop three to five-year forecast replacement strategy.

* Oversee Capital Expenditure sanctioning and implementation as required

* Compliance with Supply Chain Management responsibilities for Sarbanes Oxley process controls.

* Assignment to Departmental projects as required.

* Supports local SCM team with quality systems requirements as needed



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

* 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.

* Support development of effective metrics, KPI's and monitoring programs to assure constant vigilance with respect to Supplier Performance.

* Encourage implementation of Industry Best Practices for Supply Chain activities.

* Responsible for the implementation and continued oversight of Supplier Development program including minimally one annual performance review.

* Responsible for SAP inventory accuracy of all Emergent purchased materials located at External Manufacturers; including facilitating inventory cycle counts as required by the governing SOP.

* Monitors and maintains inventory levels of purchased materials at External Manufacturers. Works closely with procurement on placement of replenishment orders to maintain inventory levels and/or resolving delivery discrepancies and delays.

* Support Master Scheduler regarding adherence to Company's Master Production and Delivery Schedule.



Culture Management:

* Collaborate with Manufacturing Operations Management team 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 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, Operations Management, Biology, Biochemistry, Engineering or another related field.

* 3-5 years of related experience required

* Experience in working in a cGMP Manufacturing environment.

* SAP experience preferred.

* Prior Aseptic processing knowledge 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)

* Travel to External Partners required. Estimate 5-10% annually


Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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.



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.

Keywords: Emergent Biosolutions, Lansing , Supply Chain Specialist, Fill Operations, Professions , Lansing, Michigan

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