Senior Scientist

Job Summary:

The Manufacturing Organization supports the Technical Operations (TechOps) business by compliantly and successfully producing products in line with commercial cGMPs. The Sr. Scientist will be an associate within the MS&T team. The main responsibility of the Sr. Scientist is to work with Senior and Junior level associates to develop robust Upstream, Downstream or Analytical processes/assays 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.

Essential Job Duties:

• Demonstrate ability to develop new techniques, solve complex problems, author technical protocols and reports; and evaluate and implement new instrumentation or process techniques.
• Design and takes lead with regards to the execution of laboratory-based studies to screen, optimize, and scale production processes, analyzes and interprets results for novel and scientifically complex experiments, participates in process improvement, development, and qualification activities.
• Independently prepares and edits procedures or technical reports of a complex nature, including data interpretation, suitable for regulatory submission.
• Provides guidance and may manage work activities of other staff members for specific projects or objectives.
• Direct interaction and effective collaboration with project team members, including presenting data at project team meetings; critical review of data; and active involvement in solving technical challenges that arise during development.
• Interfaces with other departmental groups such as R&D, Quality Assurance, Regulatory Affairs, Supply Chain and Manufacturing
• The individual will be accountable for scientific data review including data integrity verification, statistical analysis and technical report writing.
• 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.
• A flexible schedule with the ability to do some shift work and availability on weekends.

Job Requirements:

• Bachelor's Degree is required. Degree in Biology, Chemistry, Chemical Engineering or closely related scientific / technical discipline is preferred.
• Minimum of 12 years of related experience in product development, manufacturing science and technology, process engineering within the pharmaceutical industry required • Has considerable Technical/Scientific knowledge in professional field of specialization and biopharmaceutical processes, both process development and manufacturing scales of operation
• Has considerable Technical/Scientific knowledge in professional field of specialization and biopharmaceutical processes, both process development and manufacturing scales of operation
• Has considerable knowledge and technical expertise 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
• Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements

*This job description is accurate at the date of publication . It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned, and qualifications required may change over time.

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. 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.

#SMF