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Grifols Shared Services North America, Inc Principal Analytical Scientist, MS&T in Emeryville, California

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Summary:

The Principal Analytical Scientist will be an associate within the MS&T team and will have primary oversight of the MS&T analytical operations. The main responsibility of the Principal Scientist will be to develop and lead and mentor Junior level associates to develop robust analytical methods in support of developing and optimizing recombinant protein production processes at the Grifols Diagnostics Solutions, Emeryville CA.

Primary responsibilities for role:

  • Lead a team of 4-5 scientists and can identify and request needed resources as required

  • Provide technical leadership to staff with focus on verbal and written communications, teamwork, and problem solving

  • Develop new techniques, solve complex problems, author technical protocols and reports; and evaluate new instrumentation or process techniques.

  • Will monitor, explore and evaluate next generation technologies to speed up analytical development. This individual will also be responsible for technology transfer to third parties including partners and CDMO

  • Independently designs and takes lead with regards to the execution of laboratory-based studies, analyzes and interprets results for novel and scientifically complex experiments, participates in analytical improvements, development, and qualification activities.

  • Uses scientific knowledge to make decisions on projects. Analyzes data and results and makes recommendations that impact both the science and the business

  • The individual will be accountable for scientific data review including data integrity verification, statistical analysis and technical report writing.

  • Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.

  • Leads cross-functional project teams and directs resources in the preparation of procedures or technical reports.

  • Directly interfaces with other departmental groups such as R&D, Quality Control, Quality Assurance, Regulatory Affairs, Supply Chain and Manufacturing

  • Advanced ability to set and meet deadlines, multitask, as well as to identify, request, and prioritize resources across functional area based on project needs.

Knowledge, Skills, and Abilities:

  • Technical expertise in analytical (development and qualification) methods used for recombinant proteins and monoclonal antibodies.

  • Has advanced knowledge and technical experience of analytical techniques such as SDS-PAGE, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits, Lowry, Bradford, Western Blotting, Mass Spectrometry, Dynamic Light Scattering, and Differential Scanning Calorimetry (DSC).

  • Demonstrate an understanding of above techniques and able to troubleshoot methods and recognize anomalous data

  • Ability to introduce new/modern analytical techniques that can reduce times and increase throughput

  • Experience in analytical technology transfer within and between organizations (internal and external), manufacturing support and troubleshooting

  • Independently applies sound scientific principles in development of innovative solutions to complex technical problems.

  • Influences the development of overall objectives and long-range goals of the organization.

  • Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.

  • Demonstrated teamwork, organizational, and leadership skills

  • Extensive working knowledge of cGMP environments (understanding of equipment, technology, and quality systems requirements)

  • Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.

  • Proficient with the use of MS Office software(MS Excel, MS Word, MS Powerpoint) and application software including Unicorn, JMP, Minitab, Design Expert etc).

Education:

  • Bachelor’s Degree in science or engineering preferred with a minimum of 15 years of experience, Masters with 13 years or PhD with 10 years in product development, manufacturing science and technology, process engineering within the pharmaceutical industry required.

  • 7 years of experience working in a pharmaceutical manufacturing site

  • Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements

Occupational Demands:

  • 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: 242087

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