Manager, External Manufacturing Ops

Location: 

Gaithersburg, MD, US, 20879


 

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.

Manager, External Supply role is a highly visible hands-on position that will have sole responsibility for managing assigned external manufacturing partners for Emergent.  Responsible for end-to-end supply chain and customer fulfilment supporting current and new products for both Commercial and Medical Countermeasure Business Lines.  Works closely with Quality, R & D. Technical Operations, Regulatory Affairs, and Sales Operations delivering on our commitments and exceeding Customer expectations while upholding Emergent’s high level of customer service, compliance standards and product requirements.  Using Operational Excellence principles, develops strategic plans to improve productivity, quality, and efficiency of operations.  

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

General Responsibilities:
•    Point of contact for External Manufacturing Operations activities including scheduling, issue resolution, change management implementation, performance monitoring, supplier development, etc.
•    Represent Supply Chain as a dedicated or support member on applicable Integrated Teams serving as the End-to-End Commercial Supply Chain representative. 
•    Responsible for Product and component planning and delivery to ensure uninterrupted supply.
•    Responsible for creating and maintaining data in SAP system in accordance with Global Departmental Capabilities and procedures.  Execute transactions to support supply chain operations. 
•    Represent External Supply and present at S & OE meetings
•    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.
•    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.
•    Ensure successful Performance Management process execution to drive consistency between Company and Department Goals as well as Objectives and Day-to-Day business operations.

External Manufacturing Operations 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 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.
•    Familiarity of Domestic and International distribution regulations and requirements.

Culture Management:
•    Collaborate with support departments to build effective teams through mutual understanding of Company goals, objectives, communication tools and committee structures.
•    Live Emergent’s core values and operate within a Culture of Accountability.
•    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. 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s Degree in Supply Chain, Operations Management, Biochemistry, Engineering, or another related field.
•    Minimum 5 years of related experience within medical device, combination drug device, biotechnology, pharmaceutical, or contract manufacturing industry required
•    Experience working in a cGMP Manufacturing environment.
•    Ability to work within a matrixed organization
•    Multiple disciplines in CMO management, aseptic fill operations, tableting, device assembly/packaging under cGMP. 
•    Hands on experience with SAP preferred 
•    Exhibit strong leadership skills with particular emphasis on relationship development and implementation of company culture improvement initiatives.
•    Ability to collaborate with internal and external partners at multiple levels.
•    Ability to manage, prioritize and work cross functionally with team-oriented focus to influence behaviors and gain consensus 
•    Effective communicator with strong leadership and interpersonal skills
•    APICS or other accredited Supply Chain Certification preferred.
•    Six-sigma/LEAN certified preferred. Must have continuous improvement mindset with strong LEAN principles and practices.
•    Experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint, Visio).

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Washington DC