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 at our Canton site location. The successful candidate will have a Bachelor’s Degree in a scientific discipline, a minimum of 3-5 years of related experience in a GMP biopharmaceutical/biotech production environment and have a technical understanding of equipment and operations common to executing procedures in support of cGMP FDA licensed manufacturing areas. The ideal candidate must be quality focused with knowledge and understanding of cGMP quality systems and their applications to manufacturing operations. 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 Manufacturing 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 focus on Upstream Cell Culture activities including unit operations of Static and Dynamic Cell Culture, Microcarrier Separation and Concentration. The candidate will also conduct general GMP operations as needed to support activity including equipment assembly, solution preparation, operation of autoclaves, and parts washing. Knowledge and experience of aseptic behavior is a benefit to the candidate. Responsible for operating in a safe and compliant manner, to ensure production goals are met.
- Assumes a lead role in the production processes for bulk vaccine manufacturing in accordance with cGMP documentation for Upstream Cell Culture activities including unit operations of Static and Dynamic Cell Culture, Microcarrier Separation and Concentration. Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision.
- Reports regular status of production operations to both management and production team.
- Works with other departments and personnel on projects related to licensed process including Validation, Facilities, M-Tech, and Quality groups.
- Demonstrates expertise on some or all related areas of licensed process.
- Ensures all training requirements are completed per the standards set forth by the site.
- Maintains a cGMP ready state of production facility. All work is documented compliantly within logbooks and batch records in accordance with good documentation procedures.
- Contributes to the quality compliance aspect of the needs of the department in the areas of document revision, deviation report writing and assisting in the execution and implementation of change controls.
- Identifies any procedural issue including process deviations, troubleshoots issues immediately, and assists with investigation and potential corrective actions to quality incidents.
- Acts as SME or system owner for specific pieces of equipment and procedures. The candidate will assist supporting departments by contributing towards the execution of maintenance, validation, and qualification of equipment and procedures as necessary.
- 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.
EDUCATION, EXPERIENCE & SKILLS:
• Bachelor’s Degree in a scientific discipline required. Substitution of Associate’s 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 equipment and operations common to executing procedures in support of cGMP FDA licensed manufacturing area.
• Must be quality focused with knowledge and understanding of cGMP quality systems and their application to manufacturing operations.
• Ability to maintain and operate common 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 under the career section 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.