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Director of Analytical Development

Company: Salubrent
Location: Kannapolis
Posted on: November 17, 2021

Job Description:

Director of Analytical DevelopmentSalubrent Pharma Solutions - Kannapolis, NC 28081. Position Summary. Director of analytical development will be responsible for analytical activities for Salubrent customers in support of drug substance and product manufacturing and testing.. Key Responsibilities. Provides strategic leadership and technical expertise in analytical method development for release and stability testing of drug substance, raw materials, intermediates, and drug product.. Review the available literature and gain knowledge on the product assigned. Involved in execution of routine testing and validating the methods for solid dose and aseptic products. Involved in execution of methods for analysis of new products or modification of existing products to meet customer specifications and regulatory requirements. Coordinates with customer internal departments to review, approve qualification/validation of analytical methods. Manage customer product stability study programs. Supervise/train analytical chemists, scientists, or technicians to ensure their activities comply with project and organizational goals and departmental cGMP/ cGLP regulations.. Involved in critical thinking & testing to face challenges in a project. Calibrate in-process testing equipment. Assists in evaluation and testing of raw materials, in-process and finished dosage forms. Communicate internally with stakeholders and internal staff to support project advancement and improving transparency & distributing timely information about the project.. Provide strategic inputs for the project advancement.. Collaborate with scientists and technicians in the formulation department, reviewing their laboratory notebooks,. Support and coordinate the recruitment process of new hires and the development of the analytical team.. Manage multiple projects simultaneously and report project progress to the customer and internal project manager.. Qualifications and Requirements. Bachelor's degree in Chemistry or related field with 5+ years or PhD with 3+ years of pharmaceutical industry experience in solid oral formulation analytical development, sterile experience is a plus.. Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, dissolution, and particle size.. Functional understanding of analytical development and associated regulatory and quality requirements.. In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance.. Excellent verbal and written communication skills. Problem solving and good interpersonal skills. Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities. Able to work in a cross-functional team environment and to be a team player as well as the ability to work independently. Willingness to travel periodically as needed (when travel conditions permit). About Salubrent. Established in 2020, Salubrent Pharma Solutions is a technology enabled Contract Development and Manufacturing Organization (CDMO) focused on offering flexible, state-of-the-art aseptic services to clinical and commercial stage life science companies in critical need of small batch development and production of sterile injectable products beginning in late 2022. Salubrent's Analytical Services division will be the first revenue generating division by providing full-service analytical development and testing services from our Kannapolis, NC laboratory location.. Thousands of employers search for candidates on Indeed. Yes. -. I plan to apply. -. No, I don't intend to apply

Keywords: Salubrent, Kannapolis , Director of Analytical Development, Executive , Kannapolis, North Carolina

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