Scientist

<p><b>What You Will Achieve</b></p><ul><li>Consistently performs routine and complex analytical chemistry activities with a degree of independence.  Demonstrates technical expertise in one or more analytical areas. </li><li>Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, inprocess samples, finished product, process &amp; cleaning validation samples, package samples and components as well as some specialized techniques.</li><li>Assays are performed in compliance with USP, FDA and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements.  In addition, the individual writes, reviews and approves protocols, reports, and investigations associated with the laboratory and to support method validation activities.</li><li>This position is responsible for providing time sensitive in-process testing in support of Operations as needed and with OBE 5 drug products.</li><li>Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations.  This may require adjusting work hours as required or needed.</li><li>Compiles validation data into comprehensive reports.  Work on analytical methods in support of new product launches and existing marketed products.  Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes.  Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize, excipients, in-process materials, and finished products. </li><li>Participate in Laboratory investigations, create Change Control, revise test methods, write protocol and perform approvals.</li><li>The position is accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements.</li></ul><p></p><p><b>How You Will Achieve It</b></p><p></p><p><b>Conducts assays</b></p><p>In addition to high technical competence, the colleague understands and can articulate the <span>scientific/regulatory</span> principles that underlie practices and guide future <span>projects/studies/reviews</span> development. </p><p></p><p><b>Analyzes results</b></p><p>Analyzes and interprets <span>project/study/investigation/review</span> results independently.  May utilize Laboratory Information Management Systems (LIMS).  Develops problem solving skills.  Makes tactical decisions independently based on the results. </p><p></p><p><b>Trains &amp; Mentors</b></p><p>Trains analysts in new and existing procedures, techniques and governmental regulations as directed by management.  Takes initiative; seeks out additional assignments, etc.</p><p></p><p><b>Lab Support</b></p><p>Responsible for planning and execution of all tasks needed to achieve routine goals. Seeks advice on planning from management when there are priority conflicts. Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner.  May assist in coordinating the testing activities of the group.</p><p></p><p><b>SOPs and Admin</b></p><p>Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.</p><p></p><p><b>Here Is What You Need</b></p><p></p><p>Applicant must have a BS/BA in Chemistry or Biochemistry or Advanced degree preferred with 6 years of experience; OR MBA/MS with 4 years of experience.</p><p>This position requires 6 years' experience within Quality Control or other relevant analytical experience in the pharmaceutical industry. General lab equipment. Equipment troubleshooting.</p><p>Candidates will have prior experience in most, if not all, of the following:</p><ul><li>Making sound and effective decisions under pressure</li><li>Working with other manufacturing sites to understand a broader perspective</li><li>Exposure to Regulatory inspections including direct interactions</li><li>Ability to effectively work within Quality Control, and across network channels, to accomplish goals</li></ul><p>Knowledge of the following areas are critical for success in the role:</p><ul><li>ICH and other applicable industry standards</li><li>Understanding the principles of Data Integrity</li></ul><p></p><p><b>Organizational Relationships</b></p><ul><li>Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role <span>responsibilities. </span> Include any external interactions as appropriate.</li><li>Manufacturing.</li><li>Work priorities, provide information, discuss problem batches, <span>manufacturing/technical</span> issues, deviations and other events with potential impac