Senior Specialist Data Review - Biologics (Large molecules)

Position Summary:
Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations

Essential Duties and Responsibilities:

• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
• Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, compound evaluation and other subjective review based on testing performed; perform complex calculations to verify results
• Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
• May serve as technical advisor for analysts with regard to QA/QC of data
• Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area
• Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees
• Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas
• Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
• Conducts all activities in a safe and efficient manner
• Attention to details
• Works in collaboration
• Performs other duties as assigned
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrate and promote the company vision
• Regular attendance and punctuality
• Read and understand analytical procedures

Education/Experience (BMQ:
Master’s degree in a science-related field with 6-10 years of experience in Bio/Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements.

Theoretical / Practical experience with analytical techniques such as Ligand binding assays, ELISA, Gel electrophoresis, Proteomics, Flow Cytometry, TEM, PCR, cell culture and cell-based assays (such as reporter gene, cell signaling, and cell proliferation). etc. Knowledge of USP/EP compendia, and laboratory software applications such as LIMS, Electronic Notebook is preferred.

Key Candidate Attributes:

• Self-motivation; excellent quality of work and attention to detail
• Ability to communicate effectively with coworkers and internal/external clients
• Ability to learn new tasks quickly and to move easily from task to task
• Ability to handle prioritization and multiple tasks simultaneously
• Ability to use a personal computer and learn necessary programs
• Good communication skills (oral and written)
• Organizational ability and good judgement
• Science background/education and/or laboratory experience
• Strong Math Skills
• Logical Thinking, Good Reasoning Ability
• Motivation to excel
• Coaching/mentoring of peers