This individual will be an integral leader of process development for our viral vector program and help advance our client's portfolio of cell therapy products. The individual will be responsible for viral vector process design and development, scale up processes as well as monitoring of the viral manufacturing platforms to support continuous
platform advancement opportunities.
location: Arcadia, California
job type: Permanent
salary: $170,000 - 200,000 per year
work hours: 9 to 5
education: Masters
responsibilities:
- Establish internal analytical capability for vector release, characterization and in-process assay development.
- Develop and implement state-of-art and innovative viral and non-viral analytical methods to support platform development for Upstream, Downstream, Formulation functional areas, and qualify assays
- Responsible for analytical related SOPs, methods, and reports, generate reference standards, assay qualification/validation protocols, and reports related to vector manufacturing
- Establish tracking and trending analyses of process development and cGMP production runs, including evaluation of critical reagents and a lot-to-lot variability, in order to improve process standardization
- Collaborate closely with other departments to enable effective and successful project
- development; actively engage in cross-functional collaboration with peers to overcome
- challenges
- Serve as internal SME on Analytical Analysis and prepare reviews or edit regulatory documents and responses to questions for FDA and/or international agencies
- Draft timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologies
- Participate and influence cross-functional development team to advance production activities
- Develop manufacturing processes for viral vector products and develop process improvements and efficiencies
- Author, review and approve technical documentation, including but not limited to study
- protocols, process development and validation reports and process/manufacturing sections of regulatory document
- Lead and develop a high-performing team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PD organization as well as being a key player in interactions with stakeholders and partner organizations
- Lead and oversee the design, planning and execution of studies to support cutting edge process design and development
- Develop and execute process characterization studies to develop a thorough understanding of operating and performance parameters
- Foster growth and development of staff, including hands-on training if needed
qualifications:
- MS/PhD in Molecular Biology, biochemistry, chemical/biochemical engineering or related disciplines with a minimum 5+ years of in-depth technical experience in purification process development for viral vectors
- Knowledge and experience in purification process engineering and process scale-up/scale-down design is essential.
- Leadership experience as a successful
leader in a strategic multifunctional environment. - Strong business acumen and critical thinking.
- Industry experience in process characterization and validation.
- Hands-on experience with technology transfer of manufacturing process.
- Knowledge of cGMP, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Excellent interpersonal communication and presentation skills.
skills: Cell Biology, GMP (Good Manufacturing Practice), Process Engineering
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.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.