Analytical Development Scientist

Description:The Scientist, Analytical Development will act as the subject matter expert and operate as an independent researcher in the lab. You will conceive, implement, and analyze experiments to produce independent data. You will be responsible for method development, validation, and transfer of methods used to test biopharmaceutical products or raw materials. You will be responsible for complex decision-making and re-evaluation, optimization, and troubleshooting of methodologies as requested and will lead technical discussions with clients. In addition, this position will guide Analysts regarding their performance and will manage small to mid-sized projects to ensure completion promptly to the satisfaction of both the client. Execute experiments, following the company’s SOPs, Deviations, and Change Control programs and cGMP guidelines Perform development and validation of analytical testing procedures for drug substances, drug products, and raw materials Make complex decisions and perform activities relating to the writing of test protocols, method development, and validation of analytical testing procedures Participate in and lead investigations for OOS, OOT, and deviations. Participate and execute Corrective Preventative Actions (CAPA) Duties include preparation for testing by using good time management skills for each assigned task, adequacy of testing documentation, proper application of test procedures, proper techniques for data capture and recording, and preparation of the final report of analysis Utilize advanced analytical techniques to identify root causes and determine courses of action Provide expert technical support to clients, internal and other groups Ensure equipment is adequately maintained; perform calibrations and qualifications as required In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations in identifying the cause of failure, and prepare a deviation report and CAPA if it is appropriate Ensure that all client requests for analytical testing information or time and materials estimates for quotation purposes (or information regarding any other services) are met in a timely and effective manner Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective mannerSkills:ftir, karl fischer, analytical chemistry, Laboratory, Gmp, IQ OQ PQ, instrumentationAdditional Skills & Qualifications:Bachelor's degree in Chemistry, Biochemistry, Biology, or a related field3+ years of experience performing advanced method development and testing, analysis, and data interpretation in a regulated pharmaceutical or biopharmaceutical lab environmentMaster's degree in Chemistry, Biochemistry, Biology, or a related field 1+ years’ experience performing advanced method development and testing, analysis, and data interpretation in a regulated pharmaceutical or biopharmaceutical lab environment PreferredExperience Level:Intermediate LevelDiversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.About Actalent Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.