Job Description:

• He/She collaborates with scientific staffs to plan experimental work and executes protocols in support of biologics process development, formulation development, and stability studies.
• The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products.
• The individual is also responsible for writing sections or subsections of technical reports, method and/or operational SOPs.
• He/She independently carries out multiple analytical methods to support Client biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

Responsibilities:

• The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories).
• Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Client internal and applicable regulatory requirements.
• Client internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
• Support development of phase appropriate separation methods to support toxin development programs
• Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
• Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
• Make high quality scientific presentations at internal management, regional and national meetings to help advance Client's image as the thought and product leader in the neuromodulator field. Present and defends product, assay and process data to regulatory agencies.

Qualifications:

• Bachelor's Degree or equivalent education with typically seven years of experience, or Master's Degree or equivalent education with typically five years of experience.
• Preferably someone with a bachelor's degree and several years of experience or with a master's degree and up to a few years of experience. I am open to hiring someone with a bachelor's degree and only some industry experience or master's degree and limited industry experience.
• Experience in the area of developing and qualifying in vitro cell-based assays to reflect the relevant molecular mode of action.
• Experience in cell culture and state-of-the-art cell and molecular biology techniques.
• Knowledge and experience in developing, validating, and transferring separation methods for biologics, including qELISA (quantitative), Cell-Based Potency Assays (CBPA), enzyme activity / functional assays and other bioassays.
• Understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• General understanding in CMC development strategy of biologics drugs is expected.
• Understanding of how neurotoxin structure relates to biological function is a plus.

Job Types: Full-time, Contract

Pay: $54.66 per hour

Expected hours: 40.00 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Irvine, CA 92612: Relocate before starting work (Required)

Work Location: In person