Sr. TD Scientist/Engineer II or Principal TD Scientist/Engineer I
Redwood City, CA
We are looking for a Sr. TD Scientist/Engineer II or Principal TD Scientist/Engineer I, Process Development (Upstream PD) to join the Process Development team at our Redwood City, CA office. This position reports directly into the Director (Upstream) of Process Development and will play a key role to help advance our lead program to commercial launch and our pipeline products into and through the clinic.
The incumbent will be responsible for developing, implementing, and then executing upon the operational vision for the Upstream PD group. As such, the incumbent will be expected to have a strong technical background knowledge of all Upstream processes, including cell passaging, media development, bioreactors, PAT, and scale-up. The incumbent will be expected to lead and execute on various late-stage initiatives, including process characterization using DOE/QbD principals. This role requires strong technical skills, a collaborative Team focus, the ability to juggle multiple projects, and an ability to adapt to changing priorities.
- Identify and lead efforts to evaluate process changes with the goal of optimizing the existing AAV manufacturing process to enhance robustness, scale-ability, and/or yield
- Technical involvement in the design and implementation of Upstream process development activities, including scale-up, media development, lysis, filtration, and process characterization
- Author and review technical documentation including development reports, risk assessments, process descriptions, and process history
- As Process Subject Matter Expert, lead process related investigations, including designing and executing investigational studies at small-scale
- Independently solves complex technical problems of ranging scope
- Follow appropriate laboratory procedures and produce competent and reproducible results to a high technical standard
- Appropriately analyze data, interpret and present results to cross functional teams, and maintain accurate records with no supervision
- Ensure safe workplace in compliance with the company and EHS rules and regulations
- Collaborate and work closely with other Process Development teams, Analytical Development, Technology Transfer, External Manufacturing, Regulatory and Program Management to understand and deliver on customer requirements
- Coordinate and manage day to day activities in the lab in order to adhere to the company's timelines and goals
- Routinely mentor junior associates on scientific background and technical aspects of work
- Represents our company at technical presentations and conferences to showcase our capabilities at the cutting edge of AAV upstream process development
- Other responsibilities may be assigned as needed
- For the Principal TD Scientist/Engineer I position, PhD with 7+ years of industry experience or MS/BS with 12+ years of industry experience with a Biochemical or Chemical Engineering degree is required
- For the Sr. TD Scientist/Engineer II, PhD with 5+ years of industry experience or MS/BS with 10+ years of industry experience with a Biochemical or Chemical Engineering degree is required
- Hands on experience with stir-tank bioreactor process at various scales in an industry setting is required
- Prior experience working with Baculovirus/AAV is a plus.
- Prior experience working with and/or in a GMP operating environment and technology transfer activities is a plus
- Direct experience utilizing PAT and DOE software (JMP, DesignExpert) is required
- Experience drafting technical reports and protocols is required
- A working understanding of analytical tools needed to support Process Development is required
- Highly motivated team player with excellent verbal and written communication skills, who is capable of leading by example and exceeds expectations in all aspects of the role
- People management and/or leadership experience is required.
Job Type: Direct Placement
Location: Redwood City, CA
Job ID: 21-00961
Date Updated: February 23, 2021