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Scientist, Product Development

Location: 

San Diego, CA, US, 92121


 

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 Scientist will be a key member of the Product Development team, and will report to the Director, Drug Product Development. The position will focus on development of vaccine formulations from preclinical through Phase III, and commercialization. The main responsibilities will include the design, execution, and documentation of experiments to develop formulations and processes for virus-like particle, attenuated virus, and bacterial based vaccines. The successful candidate will be able to work in a fast-paced team environment and be able to learn new skills quickly.

 

ESSENTIAL FUNCTIONS

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

•    Develop novel liquid and lyophilization formulations to improve product stability
•    Design assays to support formulation screening and characterize product stability
•    Write and revise SOPs, GLP, and GMP documentation
•    Write and review development reports to support regulatory submissions
•    Manage associates running project-specific assays (e.g. BCA/ELISA/PCR/TCID50)
•    Development of manufacturing processes for clinical material from lab scale and scaling-up
•    Work with CMO for tech transfer of process to manufacture clinical material
•    Perform biological/biochemical and/or chemical analyses based on SOP to measure product stability
•    Ensure compliance with GLP and other regulatory and safety guidelines
•    Organize and manage development stability studies
•    Analyze and present relevant data

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: PhD/MS/BS degree in chemistry, biochemistry, pharmaceutical sciences, materials science, chemical engineering or a related field.

Experience: Minimum of 0-4 years for PhD, 4-6 Years for MS, 6-10 Years for BS degree of experience in the biopharmaceutical industry

Knowledge: Applicant should be familiar with GMP and GLP guidelines, current technological developments/trends in area of expertise, scientific principles, and practices

Skills: Proficient in Microsoft Excel, Word, and PowerPoint, strong written and verbal communication skills, strong organizational skills

Abilities:

•    Follow company policies and procedures (SOPs) to complete assignments
•    Safely handle BSL2 organisms (virus like particles, virus, bacteria)
•    Understanding of bio-chemical and physical properties of therapeutic biomacromolecules
•    Understanding of molecular interaction with formulation excipients, relevant analytical techniques, and data interpretation
•    Understanding of Design of Experiment (DoE) for formulation development and supporting statistical analysis 
•    Hands-on experience with particle size characterization techniques (Dynamic Light Scattering, Laser diffraction, Particle Imaging)
•    Knowledge and experience of molecular biology techniques (Western blot, SDS-PAGE, ELISA etc.) for formulation development
•    Work independently in the laboratory to support product development
•    Understanding of the drug product manufacturing process and scale-up
•    Develop and support collaborative relationships
•    Effectively prioritize tasks and managing multiple projects
•    Summarize data for presentations and regulatory submissions
•    Analyze and present data to colleagues cross-functionally
•    Lead troubleshooting tasks to resolve complex problems
•    Lyophilization of vaccine product experience preferred
•    Experience on mRNA formulation development and lipid nanoparticles is plus
•    Experience on pre-filled syringes and combination device is plus

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: San Diego