Emergent BioSolutions (NYSE: EBS), headquartered in Gaithersburg, Maryland, is a global life sciences company that provides a diverse portfolio of specialty products and services that address public health threats. The company develops, manufactures, and commercializes medical countermeasures (MCM) against chemical and biological, (CBRN) threats, as well as explosive-related threats and existing and emerging infectious diseases (EID). In 2018, the company diversified the scope of its public health threat mandate significantly by acquiring Adapt Pharma, the maker of NARCAN® Nasal Spray for opioid overdose reversal, and PaxVax, the maker of Vivotif® and Vaxchora®, which are marketed travelers vaccines for typhoid and cholera, as well as a number of R&D programs at various stages of development.
Emergent BioSolutions continues to drive innovation and achieve significant growth YOY-growing from a company with only one product and less than $300M in revenue in 2012 to a broader base with 10 products that are now marketed or procured globally. The company is on target to exceed $1B revenues for 2019, one year ahead of plan, while advancing the founding mission to protect and enhance life. The company operates through four business units:
* CONTRACT DEVELOPMENT & MANUFACTURING
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 Quality Assurance Team Lead position is responsible for the daily coordination and execution of QA shop floor activities, ensuring batch release timelines are met, and setting daily priorities for QA shop floor team members. This position is a hands-on leadership role at Emergent which spends a large amount of time on the production floor directly overseeing operations.
In addition to coordination of shop floor activities, the team lead is responsible for execution of batch review/release, quality system work, and shop floor quality oversight of production activities.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Product Manufacturing Support
* Resolve manufacturing issues of moderate complexity with minimal oversight.
* Performs inspections of the manufacturing facilities to ensure compliance with internal Emergent procedures and cGMPs.
* Reviews Product Manufacturing records to ensure product specification and process requirements are met in accordance with Emergent standard operating procedures.
* Ensure documentation supporting product manufacturing and testing follows good documentation practices (GDP) and principles of data integrity. Troubleshoots documentation issues on the floor in real-time with manufacturing associates.
QA Shop Floor Coordination
* Provide scheduling of daily floor support tasks and oversight of floor operations.
* Act as the primary trainer of new hires in the QA shop floor
* Provide performance review feedback to Management.
* Work with area management to ensure scheduling coverage for PTO, and Call-ins to prevent manufacturing process delays.
Quality Systems and Continuous improvement:
* Author QA deviations related to shop floor activities
* Reports quality issues that may impact product delivery to Sr. Management and Value Stream
* Directly supports internal and external inspections and audits by directly interacting with auditors as a subject matter expert for QA shop floor operations
* Coordinate/lead cross functional teams in process mapping and other exercises designed to facilitate process and system understanding, and problem solving.
* Is responsible for identification and implementation of shop floor continuous improvement initiatives of moderate complexity to improve product flow and reduce product review cycle times.
* Supports Deviation investigations inclusive of a detailed root cause analysis and sufficient corrective actions.
* Communication is key in this role. Communication of daily production priorities from manufacturing leadership to the QA shop floor team members is a central responsibility of this role.
* Must have a high degree of personally accountability for meeting production timelines and ensuring site compliance with regulations and internal procedures
* High degree of integrity
* Ability to deal with interpersonal conflict in a constructive manner
* Organizational skills are required to manage the scheduling of personnel working 24 hours 7 days a week
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
* BA/BS (preferably in an applied science)/or equivalent work experience
* >5 years of experience working in an FDA regulated industry with at least 3 years of experience within Quality
* Experience with pharmaceutical manufacturing operations and cleanroom behavior
* Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
* Familiarity with Visual Inspection, fermentations, SOP revisions, performing Root Cause Analysis, CAPA, and Change Control preferred
* Ability to make sound decisions regarding moderate complexity compliance-related issues with a low level of direct supervision.
* Strong Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP) and current industry trends.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the 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.
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.