Grifols Shared Services North America, Inc Sr. Manager in Emeryville, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
The Sr. Manager will lead a team of specialists and scientists in the areas of recombinant protein process development, technology transfer and technical support for downstream Manufacturing operations at Grifols Diagnostics Solutions, Emeryville CA. The Sr Manager will have primary oversight of the MS&T laboratory/pilot plant function where suitable scale-down models will be defined and qualified as appropriate in support of process development, scale up and technology transfer, process troubleshooting during routine manufacture, and process characterization/robustness studies in support of commercialization activities.
Primary responsibilities for role:
Leads downstream/purification process development, technical support, process monitoring, and optimization/improvement activities for manufacturing
Uses scientific knowledge to make decisions on projects. Analyzes data and results and makes recommendations that impact both the science and the business
Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams
Extensive working knowledge of cGMP environments
Direct interaction and effective collaboration with other team members with regards to prioritizing resources, projects, and deliverable
Manages people (including staffing, delegation, managing and measuring work) and performance (including motivating and developing strong performers and effectively confronting and resolving performance issues)
The individual will be accountable for resource allocation, project scheduling and prioritization, scientific data review including data integrity verification, statistical analysis and technical report writing
Monitors department expenses and makes recommendations on departmental capital budget items
Strong ability to set and meet deadlines, multitask and prioritize resources based on project needs.
Maintains laboratory facilities and equipment in accordance with company policies and industrial best practices
Active participation in health authority audits (FDA, EMEA) and review of regulatory submissions
Author Product Impact Assessments (PIAs) and Risk Assessments to assist QA in the determination of the releasability of product lots as required
Drive and review Change Controls for the implementation of Purification process changes into Manufacturing
Work with QA to identify and implement appropriate Corrective Actions and Preventative Actions (CAPAs) from the root causes of investigations to prevent their re-occurrence
Lead a team of 8-10 scientists and specialists (B.S. to Ph.D. level) and can identify and request needed resources within or across functional areas.
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
Support direct and indirect staff member development through: coaching and mentoring, providing timely and candid feedback, helping craft meaningful individual development plans, and tailoring individual goals which help to contribute to successful achievement of site and corporate goals.
Knowledge, Skills, and Abilities:
Technical expertise in protein purification of derived recombinant proteins and monoclonal antibodies.
Technical/scientific knowledge of biopharmaceutical processes, at both process development and manufacturing scales of operation
Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
Has advanced knowledge of process scale-up and scale-down methodologies, including process characterization design of experiments
Experience in process technology transfer within and between organizations, manufacturing support and troubleshooting
Hands-on experience in modern protein purification techniques (chromatography, affinity, ion-exchange, hydrophobic, mixed mode, experience working with AKTA, Unicorn, clarification/filtration, ultrafiltration/diafiltration) are required.
Working knowledge of AKTA systems and associated software, AKTA Unicorn and Assist software
Working knowledge and ability to program Unicorn and Assist Plate Reader software or an equivalent
Proactively promotes positive Safety Culture and cGMP operating principles
Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
Skilled in application of standardized root cause analysis, investigation tools and methodologies.
Proficient with the use of MS Office software(MS Excel, MS Word, MS Powerpoint) and application software including Unicorn, JMP, Minitab, Design Expert etc).
Direct expertise with Lean, 5S, Operational Excellence
- BA/BS degree in chemistry, biology, engineering or related field with 15 years of related experience. MS + 14 years’; PhD + 12 years.
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.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
EEO Minorities/ 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. 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.
Req ID: 250727_1