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.
This role requires research into new technologies and procedures for the purposes of process development in pilot plant, technology transfer and/or process improvements. Responsibilities of primary importance are to ensure the successful execution of pilot plant studies. This role also requires the ability to train those who are less experienced on topics, techniques, and equipment for which one is considered a subject matter expert. The Bioprocess Specialist may provide technical direction on the manufacturing floor to other operations staff members, assist with problem solving/troubleshooting, and escalate risk when necessary.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Identifies, plans and implements innovative technological programs and solutions to enable the manufacture of vaccines in a high quality, and more productive manner.
• Serve as a subject matter expert for GMP manufacturing equipment in their respective area of responsibility
• Contributes to process design and technical transfer activities.
• Writes, revises and executes all types of controlled documentation (SOP’s, Production Batch Records, Technical Reports, Protocols, etc.).
• Interfaces with Validation, Engineering, Facilities and Operations personnel in start-up, testing and operation of new or improved manufacturing equipment.
• Presents data/project updates to Emergent management and inter-departmental teams
• Develops project plans including work scope, timeline and cost estimates for process improvements
• Participate as department representative in various site/company initiatives
• Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
• Leads/facilitates root cause investigations and/or problem-solving initiatives
• Establish tracking and trending analyses of cGMP production runs
• As necessary, may assist with operational testing/qualification of biopharmaceutical manufacturing equipment.
Some night and weekend work may be required.
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
• Minimum of 3-5 years of biopharma experience
• Bachelor’s degree in Engineering, Life or Physical Sciences or commensurate experience.
• Strong knowledge based regarding the installation, operation, cleaning and maintenance of pharmaceutical manufacturing equipment
• Knowledgeable on application and practices of current GMP’s, international regulatory requirements and guidelines.
• Computer literate (Word, Excel and PowerPoint)
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.
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.