Full-Time Sr. Scientist R&D
Job Description
*Job Title:* Senior Scientist R&D *Location: *Baltimore, MD *Job Description: * Responsible for the development of analytical methods for pharmaceutical drug development including Extractable and Leachables studies. Manage a team of laboratory analysts and perform Laboratory duties as needed *Key Tasks and Responsibilities: * * Position includes direct reports. Lead team of direct reports/analysts to complete assigned tasks * Assign daily tasks to direct reports. Ensure that the analysts are trained on assigned tasks and that they are in good compliance. Alert Project Manager and/or Operations Director of potential issues * Maintain SME status for instruments used in method development activities or assigned laboratory (as applicable) * SME on method development activities (as assigned by supervisor). Ensure that methods (if successful) will pass validation criteria if applicable. Transfer methods after full development activities to validation. * Maintain Extractable/Leachable laboratory. Develop methods for Extractable and Leachable studies. Participate in management of Extractable/leachable programs. Participate in Business Development activities, including reviewing Proposal and Scope of Work * Assist Project Manager in planning client and project timelines * Assist Project Manager in tracking labor hours of direct reports for assigned tasks and ensure the hours align with approved budgets (as applicable) * Ensure laboratory equipment is under calibration before use. Notify Operations Director and/or Quality Manager of equipment issues * Ensure assigned laboratory(ies) are kept in cGMP compliance and are tidy. Participate in continuous improvement of laboratory organization and efficiency. Review OQ/PQ documents as required. * Participate in project kick-off meetings, client meetings and phone calls as required by Project Manager or Operations Director * Plan project resource needs and communicate to Operations Director and Project Manager * Create or review study protocols, test methods and study reports. Route them for review internally as well as client. Ensure timely signature of these documents * Assist Project Manager in interpreting data. Prepare data and summary tables, graphs, etc. for final reporting as per client specifications * Review data collected by direct reports on a periodic basis * Lead or participate in laboratory investigations as needed * Submit binders for data upon study completion. Update Project Manager of submission status * Participate in performance reviews of direct reports * Approve timesheets of direct reports, review PTO request from direct reports and submit to supervisor for final approval (as applicable) * Develop personal goals for Management by Objectives (MBOs) with the help of supervisor, work toward those goals throughout the year. Make recommendations to supervisor for raises and bonuses of direct reports * Attend training and seminar to improve technical and supervisory skills as assigned by supervisor. * Create and verify spreadsheets for data entry and final reporting. * Maintain laboratory equipment per SOPs * Ensure laboratory area remains clean and orderly and organize cleaning operations as needed * Conduct training for analysts on study protocols and test methods. * Supervise receipt and shipment of client samples, chemicals, packages and documents. Assign these tasks to direct reports as needed. * Train analysts on laboratory equipment, assign training tasks to direct reports as needed, help Operations Director in designing and implementing cross-training activities * Train analysts on various in-vitro laboratory techniques pertaining to nasal sprays, pulmonary products (such as metered dose inhalers, dry powder inhalers, nebulizers) and other pharmaceutical dosage forms as per the FDA guidelines * Maintain SOPs as assigned * Proficiency with Microsoft Office Word and Excel * Follow cGMP guidelines and ensure cGMP are followed within laboratory area * Other duties as assigned by supervisor *Supervision: * * Ability to supervise Analysts * Assist direct reports in planning growth and development * Maintain knowledge of company policies and follow them consistently * Approve timesheets and requests for PTO (as applicable) * Complete annual performance review (as applicable) *Skills and Attributes: * * Ability to complete projects within budget and in a timely manner * Ability to work independently take initiative and handle multiple tasks simultaneously with minimal supervision and adhere to reporting deadline schedules * Follow safety rules and regulations * Strong organizational skills * Ability to meet deadlines * Strong communication skills * Strict attention to detail * Superior speaking skills * Ability to travel * Ability to lift up to 25 pounds *Experience Requirement: * * Master’s Degree at minimum (PhD preferred) in Analytical Chemistry or related discipline * Minimum Five (5) years of experience in the pharmaceutical industry in analytical method * development / validation with strong emphasis on HPLC, GC and MS Why Kelly®? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of [benefits](https://www.mykelly.us/us-mykelly/perks/)?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. [Equal Employment Opportunity is The Law.](https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) ]]
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