Analytical Development Analyst - Abzena

Analytical Development Analyst

Location: San Diego, CA
Area: Quality

Abzena San Diego is seeking a talented individual to join our Analytical Development group in San Diego, CA. As a member of the Analytical Development team, this role will support product development programs at Abzena. Specifically, the individual will provide a technical support in developing and optimization of analytical methods to support process development, product pre – formulation studies, material release and in-process monitoring; draft analytical test methods, product specifications, method qualification/validation protocols and reports.

 Current Responsibilities

  • Provide technical support in developing and optimization of analytical methods to support process development, product pre – formulation studies, material release and in-process monitoring.
  • Experienced/proficient at least three of the following methods: HPLC, CE, PCR, SDS-PAGE, ELISA, DLS, DSC, HIAC and functional assays.
  • Support assays qualification and transfer to Quality Control lab, generate assay qualification and validation protocols and reports.
  • Perform assay troubleshooting and improve analytical methods as needed.  Data interpretation and analysis.
  • Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols.
  • Author and review documents such as Standard Test Methods, Technical Reports.
  • Support continuous improvement of lab processes for increased efficiency.
  • Interact closely with Quality Control and R&D Departments.
  • Maintain Analytical lab equipment, follow the schedules for the appropriate calibration and maintenance activities.  Provide assistance as needed during IQ/OQ.
  • Provide assistance as needed to maintain functioning Analytical Laboratory, including material ordering, inventory control and other duties.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
  • Safely operate laboratory equipment in accordance with established practices.

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena’s policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena business.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.

 

Qualifications/Skills Required:

 

  • BS degree in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
  • Minimum three (3) years’ experience.
  • Required experience in optimization, development and qualification of analytical methods.
  • Experience with three or more of the analytical methods such as HPLC, CE, DLS, DSC, HIAC and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is required.
  • Experience with understanding basic principles of HPLC and plate based assays such as ELISAs.
  • Knowledge of and experience in GMP, following STM’s, or willingness to become GMP proficient.
  • Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
  • Ability to use routine laboratory equipment including, but not limited to, HPLCs, plate readers and electrophoresis equipment.
  • Ability to work well under pressure, multi-task, be organized and have good communication skills.

 

 

FLSA:  Exempt

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