Grifols Shared Services North America, Inc Specialist, MS&T in emeryville, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
The Specialist will serve as a subject matter expert in the Fermentation Manufacturing areas. The main responsibility of the Specialist is to provide technical expertise in the areas of process development, scale up and technology transfer, process troubleshooting during routine manufacturing, and process characterization/robustness studies in support of commercialization activities.
Primary Responsibilities for the Role
Works with associates with regards to process development, technical support, process monitoring, and optimization/improvement activities for manufacturing
Supports process technology transfer and scale-up to commercial facilities
Executes laboratory-based studies, analyzes and interprets results, participates in process improvement, development, and qualification activities
Support with ability to drive Manufacturing Process Improvements
Ability to support Manufacturing technically in the event of an issue.
Work with Quality to conduct comprehensive deviation investigations in the event of failure events to identify root cause and corrective actions.
Author Product Impact Assessments (PIAs) and Risk Assessments to assist QA in the determination of the releasability of product lots as required
Own and manage assigned corrective/preventative actions (CAPAs).
Ability to Initiate, own, and manage change control records as required to support departmental projects and assigned CAPAs
Revise applicable department documentation including Batch Production Documents (BPDs) and Standard Operating Procedures (SOPs).
Support Scientists/Engineers with maintaining equipment in labs to ensure efficient performance of activities.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Knowledge, Skills, and Abilities
Knowledge of process scale-up and scale-down methodologies, including process characterization design of experiments
Experience with upstream mammalian cell culture/microbial derived recombinant proteins and monoclonal antibodies production processes.
Support efforts for developing and optimizing upstream 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
Familiar/experience with different harvesting and cell lysis techniques such as centrifugation/continuous centrifugation (disc stack centrifuge), filtration, dynomill, microfluidzer
Working knowledge and experience in cGMP environments (understanding of equipment, technology, and quality systems requirements
May be required to work periodically out of normal business hours
Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment.
Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.
Proficient with the use of MS Office software(MS Excel, MS Word, MS Powerpoint) and application software including Unicorn, JMP, Minitab, Design Expert etc).
Exposure to SAP a significant plus
5S, OpEx, and Lean manufacturing experience a plus Education Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology)Minimum Requirements: BS with a minimum of 3+ years’ experience in a regulated biotechnology / medical device industry, or minimum 1+ years’ work experience with a Masters degree. Equivalency 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.
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.
Learn more about Grifols
Req ID: 120348
Type: Regular Full-Time
Job Category: Manufacturing