Lead BioProcess Associate
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.
LEAD BIOPROCESS ASSOCIATE
Emergent BioSolutions is currently seeking a Lead BioProcess Associate for our Canton Location. The successful candidate will have a bachelor’s degree in a scientific discipline and a minimum of 3-5 years of related experience. Substitution of Associate Degree, Program Certificate, or High School Diploma will be assessed based on additional experience and working in a GMP environment. The ideal candidate will have a technical understanding of operations carried out within a cGMP manufacturing area and understanding of MFG operations and cleaning techniques, have the ability to maintain and operate laboratory equipment and have excellent written and verbal communication skills. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
The Lead Bioprocess Associate is primarily responsible for assuming a leadership role in the context of the production of bulk vaccines in accordance with cGMP documentation to meet the production schedule and goals of the site. Operations include Media/Buffer Preparation including aseptic processes, operation of autoclaves and parts washer, manifold preparation, filter testing, and cross-functional production activities as needed. Responsible for operating in a safe and GMP compliant manner, to ensure production goals are met.
- Assumes a lead role in the production processes described in the job summary for bulk vaccine manufacturing in accordance with cGMP documentation in the manufacturing area. Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision.
- Works with other departments and personnel on projects related to licensed process including Validation, Facilities, MSaT, and Quality groups.
- Reports regular status of production operations to both management and production team.
- Experienced in Media/Buffer Preparation. Ability to perform aseptic process operations as required by operating procedures.
- Operation of autoclave, parts washer, filter integrity tester, manifold preparation, and production activities as needed.
- Maintains equipment in area as required per procedure and observes cleaning techniques and performs cleaning activities in the area as directed.
- Experienced in initiating and performing Deviation investigations.
- Ensures training requirements are kept up to date in operations being performed.
- Maintains a cGMP ready state of production facility. Documents work performed in logbooks and batch records in accordance with good documentation practice procedures
- Identifies and initiates process deviations, troubleshoots issues immediately, and assists with investigation and potential corrective actions to quality incidents.
- Owns quality systems including document revisions, deviations, change controls, CAPAs and effectiveness checks.
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 & SKILLS:
- Bachelor’s Degree in a scientific discipline required. Substitution of Associate Degree, Program Certificate, or High School Diploma will be assessed based on additional experience working in a GMP biopharmaceutical/ biotech production environment.
- A minimum of 3-5 years of related experience in a GMP biopharmaceutical/ biotech production environment.
- Must have a technical understanding of operations carried out within a cGMP manufacturing area and understanding of MFG operations and cleaning techniques. Must be quality focused with knowledge and understanding of cGMP quality systems and their application to manufacturing operations.
- Ability to maintain and operate laboratory equipment such as pH meters, conductivity meter, filter integrity tester, scales, pumps, and autoclave.
- Excellent written and verbal communication skills.
- Must be a team player and able to work cross-functionally in a matrixed environment.
Interested? Please visit www.emergentbiosolutions.com to apply today!
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.