Senior Associate, Product Development

Location
San Diego, CA
Posted
May 22, 2022
Ref
836203800
Hotbed
Biotech Beach
Required Education
Associate 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.

Emergent Biosolutions is seeking for a highly motivated individual to join the Product Development team and will report directly to the Sr. Scientist, Product Development. This successful candidate will focus on formulation and assay supports for clinical phase to post-commercial stages of drug product development. 

 

ESSENTIAL FUNCTIONS

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

The candidate will participate in development work and provide analytical support, including but not limited to: 

•    Design experiments and analyze results of development studies 
•    Ensuring compliance with GLP and other regulatory guidelines
•    Conducting analysis of in-process and finished formulations
•    Tracking and performing biological/biochemical and/or chemical analyses of product to ensure stability 
•    Training on project-specific assays and be able to train others
•    Performing routine molecular biological assays and analytical laboratory functions based on SOP. Conduct troubleshooting activities as needed. (e.g. BCA, ELISA, cell culture, TCID50, SDS-PAGE, etc.)
•    Developing and optimizing lyophilization cycles that are well-documented and easily scaled-up
•    Preparing reagents and formulation buffers
•    Supporting formulation screening and scale-up activities for project teams with cross-functional collaboration
•    Reviewing data obtained for compliance to specifications and reports abnormalities
•    Writing and reviewing SOP and other related GLP/GMP documentation
•    Documenting experiments with a strong attention to detail
•    Working in a team-based lab environment and providing technical/analytical supports to other Scientists and Associates 

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: A minimum of a bachelor’s degree in chemistry, biochemistry, molecular biology, pharmaceutical development, or a related field.

Experience: Minimum of 2+ years of relevant experience in formulation and product development in the biopharmaceutical industry

Knowledge: Applicant should be familiar with GMP and GLP guidelines, how to keep a laboratory notebook, and concepts of assays such as PCR/ELISA/TCID50

Skills: Strong benchtop skills, proficient in Microsoft Excel, Word, and PowerPoint, excellent written and verbal communication skills, strong assessment and problem-solving skills, and strong organizational skills

Abilities:

•    Design, execute and interpret experiments with a high degree of reliability and independence is preferred
•    High capability of multitasking and handling multiple projects at the same time in a fast-paced environment
•    Experience with handling Virus like particle (VLP), Adenovirus, live-attenuated virus and bacterial formulations is preferred
•    Hands-on experience with molecular biology techniques, e.g. ELISA, BCA, PCR, SDS-PAGE is required.
•    Ability to maintain cell culture lines (mammalian, bacterial) and perform cell-based assays (CFU, PFU, TCID50, Cytotoxicity).
•    Ability to perform characterization assays for formulation development, such as DLS, pH, Osmolality, Moisture content, UV-Vis, Intrinsic Fluorescence measurement
•    Experience with lyophilization development is recommended but not required
•    Ability to organize development stability studies and manage samples
 

 

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.