Emeryville, CA, United States
Oct 27, 2020
Biotech Bay
Required Education
Associate Degree
Position Type
Full time

The Manufacturing Organization supports the Technical Operations (TechOps) business by compliantly and successfully producing products in line with commercial cGMPs. The Scientist II will be an associate within the Upstream MS&T team. The main responsibility of the Scientist II is to work with Senior and Junior level associates to develop robust Upstream processes in support of developing and optimizing production processes including process parameter optimization, process characterization, scale-up/tech transfer for large scale product production and support successful implementation of production processes at commercial scale.

Primary Responsibilities for Role
  • Demonstrate ability to learn new techniques, work with Senior and Junior level associates to solve problems, prepare technical reports; and evaluate and implement new instrumentation or process techniques.
  • Ability to design and execute laboratory-based studies to screen, optimize, and scale production processes, analyzes and interprets results for scientifically complex experiments, participates in process improvement, development, and qualification activities.
  • Executing complex scientific protocols in a highly coordinated team environment from preparation, testing, and data analysis
  • Independently prepares and edits procedures or technical reports, including data interpretation, suitable for regulatory submission, effectively communicates technical results in cross-functional settings.
  • Ensure their own experimental and testing work is performed exactly as defined in the approved study protocols or SOPs/guidelines.
  • Maintains laboratory facilities and equipment in accordance with company policies and industrial best practices.
  • Maintaining the labs in a clean and organized manner to ensure efficient performance of activities. Coordinating vendor visits for onsite service, work with instrumentation group for other calibration events.
  • A flexible schedule with the ability to do some shift work and availability on weekends.
  • Troubleshoot, repair, clean and operate equipment as needed.
  • Improve laboratory practices to increase throughput and decrease errors.

Knowledge, Skills and Abilities
  • Has technical/scientific knowledge of biopharmaceutical processes, at both process development and manufacturing scales of operation:
  • Technical expertise in the upstream process development of mammalian cell culture/microbial derived recombinant proteins and monoclonal antibodies. Ability to lead efforts for developing and optimizing cell culture processes including process parameter optimization, process characterization and scale-up/tech transfer for large scale product production.
  • Ability to set up, operate and sample bench-scale/pilot scale bioreactors
  • Evaluate and maintain fermentation data in the databases.
  • Familiar/experience with with Applikon/Sartorius bioreactors, AMBR and/or other high throughput systems for cellular characterization and process development
  • Familiar/experience with different harvesting and cell lysis techniques such as centrifugation/continuous centrifugation (disc stack centrifuge), filtration, dynomill, microfluidzer
  • Knowledge of process scale-up and scale-down methodologies, including process characterization and design of experiments
  • Experience in process technology transfer within and between organizations, manufacturing support and troubleshooting
  • Design and write up studies to characterize Fermentation process parameters with high risks identified in the Lifecycle Stage 1 risk assessments to define their criticality and to define Proven Acceptable Ranges (PAR) for Critical Process Parameters (CPPs)
  • Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.
  • Experience in cGMP and large-scale manufacturing equipment and operations is a plus.
  • Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
  • Capable of representing the functional area on a cross-functional team and presenting technical data at team meetings.
  • Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.
  • Proficient with the use of MS Office software (MS Excel, MS Word, MS Powerpoint) and application software (not limited to) including Unicorn, JMP, Minitab, Design Expert etc)

  • Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology): PhD +3 yrs, MS +6 yrs or BS +8 yrs of experience

  • Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

EEO Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.