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Job Details


Emergent Biosolutions

Sr. Associate, Analytical Development

Pharmaceuticals

All

Full Time

On Site

No

San Diego, California, United States


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.

JOB SUMMARY

We are seeking for the highly motivated Senior Associate to join the Analytical Development team at Emergent BioSolutions in San Diego. The Senior Associate will work under the guidance of scientists on a variety analytical method development, optimization, validation, and transfer in support of vaccine product characterization, release, and stability programs. The primary focus of the Senior Associate will be to design, plan, and execute laboratory experiments, keep accurate and updated laboratory entries evaluate new technologies, analyze data, interpret and present results, and maintain detailed records per GxP requirements. Operating in a cross-functional and dynamic environment, this position may interface with the Analytical Chemistry group as methods are transferred into that group for cGMP testing and may interface with Process & Product Development and external customers.

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

• Participate in development, optimization, qualification, and validation of analytical methods (e.g., binding assay like ELISA, Octet, Gyrolab and tissue culture and cell-based immunoassays, like TCID50 and, LumaCyte, SDS-PAGE, Western blot, protein quantification, etc.) in a development as well as regulated GxP environment.
• Perform compendial methods such as pH, conductivity, osmolarity, etc.
• Generate data and analyze test results, organize data in a presentation-ready format and maintain detailed records.
• Identify potential problems, and work together with senior analyst to investigate and troubleshoot assays.
• Work productively and cooperatively with other team members as well as on independent assignments.
• Draft new or revise existing assay and instrument SOPs, worksheets, protocols, reports, and other documentation as needed.
• Assist in maintaining inventories of chemicals, reagents, reference, and other test materials and supplies.
• Perform routine maintenance and calibration of laboratory equipment and instrumentation.
• Maintain lab in inspection ready state in accordance with standard laboratory practices and procedures.
• Conduct and document laboratory work consistent with company requirements.
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
• B.S. or M.S. degree in Biology/Biochemistry or closely related scientific discipline with 3+ years (1+ years for M.S.) of relevant experience.
• Familiarity with analytical methods, assay development/transfer.
• Knowledge or/and experience with protein characterization, electrophoresis, aseptic techniques, cell culture.
• Some experience with developing, implementing, and transferring QC-suitable analytical test methods compliant with regulatory requirements is plus.
• Ability to carry through on assignments and meet deadlines.
• Ability to follow SOPs and comply with GxP requirements.
• Some understanding of regulatory requirements, including FDA/EMA, GMP, ICH, USP/EP is a plus.
• Possess a strong work ethic along with a solid organizational, time management, problem-solving, and interpersonal skills.
• Experience recording data in laboratory notebooks or data collection forms.
• Excellent written and verbal communication skills.
• Ability to work together with other as well as show some independence to design, troubleshoot, and execute experiments.
• Experience working in a fast-paced environment.
• Ability to learn new skills quickly.
• Basic computer skills, including MS Word, Excel, PowerPoint.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 [Register to View] .

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.