Specialist, Supply Chain, External Mfg Oper

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 Manufacturers ensuring adherence to quality systems, cGMP compliance, planned manufacturing and delivery targets and customer fulfilment requirements for current commercial segments along with supporting integration of new products into the portfolio.  This position is a hybrid model of working both onsite and remote.

ESSENTIAL FUNCTIONS

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

General Responsibilities:
•    Primary liason for all External Manufacturing activities including strategic scheduling, facilitating meetings, problem solving, change management implementation, performance monitoring, contract negotiation, supplier development, and total cost analysis.
•    Represent Supply Chain as a dedicated or support member on applicable Integrated Process Teams as needed.
•    Participate and provide impactful information in Value Stream Meetings related to the external manufactures 
•    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.
•    Oversight of external manufactures and responsible for developing and maintaining effective communication tools, including weekly structured meetings internally and externally and ensuringavailability of the information.
•    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 to deliver operational excellence goals

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 allocation of work to the external partners in accordance with contract requirements, planned shutdown activities and quality performance to ensure uninterrupted flow of material supply.
•    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.
•    Maintain and continue to refineeffective 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.
•    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.
•    Team player and ability to manage multiple priorities and collaborate efficiently and effectively.

Compliance:
•    Ensure maximum compliance with current Good Manufacturing Practices, Sarbanes Oxley and other areas of mandatory regulatory oversight.
•    QMS Management: Initiate, author, route and complete applicable Quality Notifications including Deviations, CAPA’s and Change Controls.
•    Create / Revise Departmental Standard Operating Procedures and Work Instructions.
•    Ensure all training requirements are met to perform work.

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.
•    5-8 years of related experience required
•    Experience in working in a cGMP Manufacturing environment.
•    SAP and Document Management (Veeva) 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 Six Sigma 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), Microsoft Teams)
•    Travel to External Partners required.  Estimate 5-10% annually
 

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.