Sr Manager, Production

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.
Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
JOB SUMMARY Responsible for the direct management/supervision of production supervisors.
Provide leadership and decision making for the Production department and oversee all aspects of prep, formulation, setup and operation of equipment and processes associated with sterile filling.
ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Oversee all equipment preparation, equipment operation, product formulation, and clean room procedures to ensure that Emergent SOPs and policies are followed and that the highest standards are met.
Monitor and ensure all personnel comply with CGMP regulations, adhere to Emergent policies, safety regulations, and adhere to Emergent SOP and Batch Record directions.
Develop and train Technicians and Supervisors through counseling and guidance.
Ensure adequate training is provided to Technicians in order for them to complete their job assignments.
Interface with the Quality Assurance, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues.
Document issues through deviations and assist with investigations, as necessary.
Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
Interact with clients and auditors to provide information and technical expertise on Component Preparation, Formulation, and Filling operations.
Provide input and help develop manufacturing schedule to ensure optimal use of resources.
Review documentation and ensure that it complies with Good Documentation Practices.
Review, provide technical expertise for, and assist in development of batch records to comply with CGMP regulations and to efficiently use Emergent resources.
Track and trend expenditures to ensure budget and client requirements are met.
Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
Provide technical expertise for these projects.
Review and approve protocols and reports.
Collaborate with Quality Assurance On the Floor (QAOTF) to identify and improve GDP and GMP practices that will result in reducing deviation creation and increase Right First Time (RFT).
Identify process improvements withing manufacturing area and partner with Operational Excellence (OE) team to increase capacity and drive efficiencies.
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 BA/BS in science or technical field with a minimum of 7 years experience in CGMP or regulated environment Minimum of 5 years of supervisory experience Lyophilization and Terminal Sterilization experience preferred.
Restricted Access Barrier (RABS) or Isolator experience preferred.
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.