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Director, Manufacturing at Emergent BioSolutions

Director, Manufacturing

Emergent BioSolutions , MA (On Site) Full-Time

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


The Director of Manufacturing is responsible for the production of viral products to meet business requirements in a cGMP manufacturing environment.Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies.Manages staff within the upstream, downstream and central services manufacturing teams to meet the site goals and priorities.Directs the production plan for upstream and downstream, coordinating activities with manufacturing staff and other cross functional departments.Overall responsibilities include manufacturing product according to production schedule and site targets, execution of production processes, review of GMP documentation, employee training, development, quality of product, deviation investigations, productivity improvements, and cost control.Expected to be a solid technical leader and people manager with good background in cell culture and virus culture operations.ESSENTIAL FUNCTIONSLead the central services, upstream and downstream functional teams in terms of production, materials managements, training and adherence with cGMP, CBER, USP, WHO, EP, JP, Global Quality Directives (GQDs) or other guidance.Develop strategies to increase manufacturing performance year-on-year, by growing capabilities and capacity within the department. Anticipate risks to business performance and take measures to mitigate them.Instill a culture of continuous improvement with gradual steps to increase reliability and efficiency within the department.Provide technical support within the manufacturing area for the design of manufacturing processes for new products or process improvements and document in peer-reviewed process flow diagrams, protocols, SWI/SOPs, batch records, and specifications. Partner with Manufacturing Science and Technology to bring new technologies into manufacturing area. Develop technical expertise in the manufacturing area and provide technical instruction on new/improved processes to appropriate audiences, primarily manufacturing Associates. Expected to be a knowledgeable and experienced leader in understanding cell culture, virus culture and downstream manufacturing operations. Direct and guide complex troubleshooting issues and ensure robust corrective actions.Execute commercial runs, engineering runs, PQ runs, or other process development studies that define critical quality attributes (CQA) and critical process parameters (CPPs) for Validation and are necessary for the startup of new processes and equipment in manufacturing. Implement and reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe and clean working environment. Attend all safety training and exercise self-disciplined to follow all HSE policies. Provide support to integrate best practices, where appropriate, into manufacturing.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 & SKILLSBachelors of Science in a related discipline with 12-15 years of cGMP experience or a Master’s of Science in a related discipline with 8-10 years of cGMP experience. Knowledge of cGMP and CFR requirementsStrong communication skills: oral/written and listeningPersonal Competencies: Self-awareness, Integrity, Team player, Creative, Highly MotivatedMust be able to work in a complex matrixed environmentMust be able to influence without authority across various departmentsPer 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.

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