Sr Director, Manufacturing Operations

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.

I.    JOB SUMMARY 
The Sr. Director, Manufacturing applies their extensive biopharmaceutical experience to lead the planning, management and execution of sterile drug product preparation, formulation, filling, inspection, labeling and packaging production activities.  Primary responsibility is to provide oversight of daily manufacturing operations for the fill/finish facility for internal and CDMO products and services.  This position will lead and coordinate the required internal resources to develop and execute the near and long-term site strategy to maximize manufacturing outcomes, and pro-actively plan for changing conditions. This position requires collaboration across the organization to deliver on site goals, operational excellence initiatives and quality improvement.    

II.    ESSENTIAL FUNCTIONS
•    Oversight and management of the processes and teams to meet the site drug product preparation, formulation, filling, inspection, labeling and packaging schedule and objectives.
•    Ensures facilities, equipment and infrastructure are operating in a state of control meeting cGMP requirements.
•    Assures all employees operate in compliance with policies and procedures, and where applicable, practice contemporary aseptic behavioral practices in accordance with cGMP requirements.
•    Ensure maximum compliance with current Good Manufacturing Practices, Good Distribution Practices, OSHA, USDA, and other areas of mandatory regulatory oversight.
•    Accountable for project deliverables, adherence to the cost center (OPEX) budget and development and management of Capital expenditure for Manufacturing.
•    Management of production areas in a safe and compliant manner; participate in and ensure manufacturing departmental compliance for both internal and external audits.
•    Support scale-up, technology transfer, and manufacturing for new product initiatives to assure operational readiness.
•    Provide technical guidance for complex manufacturing operations.
•    Resource planning, staff development and talent and performance management.
•    As required, author, review and verify the regulatory documentation related to the Manufacturing process.
•    Champion continuous improvement and operational efficiency to eliminate waste and reduce COGS with the manufacturing operations
•    Support Management development programs through participation and ensuring participation of area management under scope of responsibility.
•    Assist with development and maintenance of the Site Master Plan relevant to Manufacturing.
•    Develop and maintain performance metrics for site manufacturing activities and communicate department progress to management and staff.

•    NOTE: 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.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    12-15 years technical experience in a biopharmaceutical cGMP manufacturing environment, preferably in sterile drug product filling and packaging facility, with at least 5 of those years in an upper level management capacity. 
•    Experience with FDA, Canadian and European inspections with product launch of biologics or medicinal products is required, experience with additional regulatory agencies beneficial.
•    Extensive experience with FDA audits and regulatory requirements for operating in a cGMP facility 
•    Extensive experience working with drug product and biopharmaceutical manufacturing contract and development manufacturing organizations (CDMO), as a service provider or managing CDMO networks.
•    Strong leadership skills, both with subordinates and peers, with emphasis on relationship development and implementation of company culture improvement initiatives.
•    Works under limited supervision; work should only be required to be reviewed for accuracy and consistency with meeting overall objectives 
•    Excellent written and oral communication abilities. Must be 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. 
•    Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint, Visio) 
•    Familiarity with specialized industry software applications (SAP, JMP, Documentum) preferred but not required. 
•    Ability to effectively maintain a culture of continuous improvement is essential
•    Strong attention to detail is required

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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.