Qualifications:

• Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment.
• In-depth experience related to method development, optimization, validation, and tech transfers.
• Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data.
• Ability to provide support for regulatory and client audits, as well as interact with clients.
• A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products which could include HPLC (MWD, DAD, ELSD, RID detection), UV/Vis Spectroscopy, qPCR, Capillary Electrophoresis, MS, Genetic Analyzer, Place Readers, Gel Imagers, etc.
• Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin).
• Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs).
• Sets stretch goals and links them to strategic outcomes and business deliverables.
• Strong leadership and motivational capabilities.
• Exercises sound judgment within defined procedures and policies to determine appropriate action.
• Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them.
• Ability to be self-motivated, proactive, accountable, and flexible.
• Ability to work well under pressure, handle multiple tasks/projects and meet deadlines.
• High attention to detail, highly organized, and excellent documentation skills.
• Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.
• Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.