Lead technical activities for viral vector process development in a cGMP/FDA-regulated environment. You will execute experimental strategies, perform sophisticated analytical assays (FFU, Flow Cytometry, ddPCR), and translate complex data into actionable results. This role requires a meticulous researcher skilled in designing preventative solutions for complex analytical challenges in biopharmaceutical innovation.
location: Carlsbad, California
job type: Contract
salary: $50 - 70 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Execute analytical assay activities and experimental plans for viral vector process development.
- Perform routine testing: FFU, Flow cytometry-based potency, TCID50, qPCR/ddPCR, and ELISA.
- Generate worksheets, summary reports, and technical transfer documentation.
- Independently plan experiments, interpret complex data, and design preventative solutions for technical issues.
- Lead technical transfers of analytical methods between internal and external sites.
- Collaborate with cross-functional partners and communicate findings to technical leadership and product management.
qualifications:
Required:
- BS degree with 4+ years of experience, MS degree with 3+ years of experience, or a PhD with 2+ years of experience
- Possess knowledge and technical expertise in biologics analytical techniques and method development, including Flow Cytometry, qPCR/ddPCR, ELISA, and cell-based assays (Plaque assays, TCID50, and FFU).
- Ability to apply expert technical knowledge to design assays and to complete complex project.
- Possess critical and analytical thinking skills to effectively solve problems and improve outcomes.
- Effective communication skills for presenting scientific and technical ideas.
- Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment.
- Knowledge of ICH quality guidelines.
- Academic and/or industry-based background in Cell Biology or Virology is desirable.
skills: Cell Biology, Assay Development, Assay Method, Assay Verification, Good Laboratory Practices (GLP), Cell-based Assays, Good Manufacturing Practices (GMP), International Council for Harmonization (ICH)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
