Process Engineer Associate II, MS&T
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.
The Technology Transfer Associate position reports to an Engineer within the MSAT Department at the Emergent Bayview manufacturing facility. The individual performs research and/or development in collaboration with others on new products, formulations or processes or modifications to existing products or processes. The Technology Transfer Associate collaborates with the broader team to set developmental study objectives, executes the studies in a leading or contributing role and presents the data for internal and external communication.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Conduct, plan and lead tech transfer of one or more processes into manufacturing
• Compare manufacturing batches and evaluate process performance
• Assist in the development of clinical and commercial drug products
• Author and review technology transfer documentation (including run summaries, reports and client Presentations)
• Develop, edit, review and sign cGMP documentation
• Provide technical support for writing of project proposals, including development of process flow diagrams from process descriptions and development of a bill of materials
• Support technical writing needs of the MSAT group
• Select, integrate, evaluate and become subject matter experts of process equipment
• Support acceptance testing and training on capital equipment
• Support all MSAT team goals including covering other pipeline projects as necessary to achieve MSAT team goals
• Develop protocols, execute and report experiments that determine evaluation of key and critical process parameters
• Travel for person-in-plant (or lab) runs as required for process transfer and troubleshooting
• Evaluate incoming processes for operability and develop risk assessment plans
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
Bachelor of Science degree in an Engineering discipline or equivalent field with at minimum classroom training biologics drug substance manufacturing equipment.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Biologics manufacturing and/or technology transfer training in one or more of the following areas:
o Antibody therapeutics manufacturing
o Viral or non-viral vaccine manufacturing
o Microbial protein expression
• Hands-on biologics expression of vaccines and/or therapeutics
• Ability to work collaboratively in multi-disciplinary teams
• Excellent leadership, presentation, computer, and communication skills
• Experience using statistics software for process evaluation
• Proficient with desktop software and basic programming experience
• Experience with identifying and evaluating process equipment
• Experimental design experience
• Applied technical writing skills
• Master’s degree with relevant industry experience
• Ability to operate process and analytical equipment and other instruments
• Familiarity with analytical methodologies for determining protein structure, concentration, and purity
• Chemical engineering and/or molecular biology background
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.