Senior Specialist Data Review - Biologics (Large molecules)

Job Description 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 Qualifications Education/Experience (BMQ: Master’s degree in a science-related field with 15-17 years of experience in Bio/Pharmaceutical 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. Additional Information 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