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 SUMMARY
The Associate BioProcessing Specialist position reports to The Sr Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites.
- ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Operates pharmaceutical manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment.
- Identifies, plans and implements innovative technological programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost-effective manner.
- Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
- Interfaces, schedules and performs on-site monitoring of outside services of all manufacturing equipment.
- Acts as qualified trainer for pharmaceutical manufacturing equipment.
- Investigates and resolves problems and provides clear and concise communication to supervisor/management.
- Executes projects with moderate to minimal instruction and management oversight.
- Partners with manufacturing development and serves as the manufacturing SME for tech transfer activities and process design.
- Executes batch records according to GMP and site quality standards.
- Writes and revises controlled documentation (SOP's, Forms, Technical Reports, Batch Records, Protocols, etc.)
- Responds to off-hour alarms as assigned by the Manager Manufacturing
- Partners with and serves as manufacturing support to Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process
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
- Bachelor degree in relevant field required or sufficient scientific and technical depth has been achieved from professional experience.
- Minimum 2 years of GMP pharmaceutical experience
- Expert knowledge of the installation, operation, cleaning and maintenance of pharmaceutical manufacturing equipment
- Knowledgeable of application and practices of current GMP's, international regulatory requirements and guidelines.
- Computer literate (Word, Excel and PowerPoint)
- 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.
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.