Associate Scientist II

Location
Gaithersburg, MD
Posted
Jan 15, 2022
Ref
824221300
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time


 

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.

Develop formulations for vaccines and characterization methods for the final drug product to ensure superior stability and manufacturing feasibility. Conduct pre-formulation and formulation development studies for liquid, frozen and lyophilized vaccines. Optimize formulations to ensure superior stability and manufacturing feasibility under GMP conditions. Determine leading formulations for clinical trials. 

Within CDMO, support execution of project work.  Support various projects simultaneously in the operational execution.  Support various tech leads to execute their development plans.  Prepare documentation, experimental designs, perform sample preparation/manufacturing, analytical/characterization testing and data analysis.  Prepare data summaries and presentations.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Support scientists to develop appropriate assays to measure the content and purity of the biological and adjuvant molecules in the liquid and dry products.
•    Support scientists to develop physicochemical characterization assays and apply them at different stages of product development.
•    Perform data analysis using appropriate statistical methods.
•    Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting the project(s) progress.
•    Help to identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules in liquid and lyophilized vaccines.
•    Plan, perform and execute short and long-term stability and compatibility studies and experiments to support CDMO projects, animal toxicity studies, CTM phase I/II/III studies and more.
•    Review and interpret data and present to immediate supervisor, team members, clients and upper management on regular basis.
•    Write SOPs, protocol, monographs and technical reports; seek approval from management and R&D QA.
•    Satisfactorily completes all development, cGMP/GLP and safety training in conformance with Departmental requirements.
•    Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.  
•    Performs other duties as assigned.

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
Education: Bachelor’s degree in physical sciences with some or no previous pharmaceutical industry experience or MS degree with no industry experience.

Experience: No necessary hands-on experience in developing formulations of vaccines and biologics but strong educational/scientific relevant background expected (especially preferred is strong biochemistry, chemical engineering, protein science knowledge).

Knowledge: Strong knowledge of scientific principles and concepts related to vaccine development. Chemistry, biochemistry, DoE and JMP analysis, (plus: regulations and guidelines in pharmaceutical industry (FDA, USP, EU, others)).  Knowledge in GLP or cGMP is preferred. 

Skills: Ability to work to tight deadlines and adapt to changing priorities in a fast-paced environment; ability and understanding in the selection of appropriate stability indicating techniques for evaluation of formulations; understanding and hands-on experience in running stability programs. Measurable learnings (e.g. Can perform at an Intermediate level of Excel and Word, Typing at 50 wpm, Advanced knowledge of research protocols, etc.).

 

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.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

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.