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Research Scientist - Microbiology, Bioburden

PPD Inc.
Rahns, Pennsylvania, US
Closing date
Dec 2, 2021

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PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees. Overview Seeking a highly skilled scientist with a demonstrated track record of applying knowledge to the introduction of innovative solutions in the area of microbiology testing. This is an exciting and unique role where the applicant will have the opportunity to evaluate novel microbiology methods for testing chemical and biological products. The successful applicant will focus on the development and validation of transformational microbiology methodologies, driving execution of proof of concept studies, validation and implementation into biological and pharmaceutical products and processes. Key responsibilities * Seek rapid/alternative microbiological technologies for microbiological tests (such automated colony counters and rapid bioburden, sterility, mycoplasma and adventitious viral agent assays). * Review the technologies and advise on their feasibility. * Design and execute proof of concept studies for new rapid microbiology technologies. * Execute method development and GMP validation for the rapid methods. * Provide validation and testing data for the new method for internal advocacy and external regulatory submission. * Maintain training records and familiarity with applicable SOPs and controlled documents * Work to GMP standards as appropriate. * Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements. PPD Defining Principles: We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-LM2 Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: * An understanding of the theoretical and practical aspects of Pharmaceutical Microbiology (knowledge of rapid/alternative methodologies an advantage) * Demonstrated hands-on and/or practical experience in microbiological analysis of pharmaceutical products * Able to provide original thinking for microbiology methodology development, with particular focus on novel on line and off line microbiology testing * Experience with GMP laboratory operations and FDA regulations is strongly preferred * Strong team working skills, able to effectively work across interdisciplinary groups * Experience with molecular techniques such as NGS NexGen Sequencing is preferred * Experience in microbiology method development/validation in pharmaceutical products is preferred * Knowledge of pharmaceutical environmental and manufacturing microbiology is preferred * Capacity to think innovatively and flexibly, comfortable with complexity * Strong desire to learn/scientific curiosity, with cross functional learning agility * Proficient in Microsoft Excel and Word * Proven ability to interpret data by performing trend analysis * Proven ability in technical writing skills * Ability to independently optimize analytical methods * Proven problem solving and troubleshooting abilities * Good written and oral communication skills * Time management and project management skills * Ability to work in a collaborative work environment with a team Working Environment: PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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