Senior Method Transfer & Validation Scientist Job at Insight Global, Sanford, NC

aDNKTGJIVzlOT3pCZWRWWFZvYVpaZG56R3c9PQ==
  • Insight Global
  • Sanford, NC

Job Description

Job Summary: Our pharmaceutical client is seeking a highly skilled and experienced Senior Method Transfer and Validation Scientist to join our team. The successful candidate will have a strong background in analytical chemistry, specifically in method transfer and validation. This role will involve overseeing and coordinating the transfer of analytical methods from development to quality control laboratories and ensuring that these methods are accurately validated and compliant with regulatory requirements.

Key Responsibilities:

  • Lead and manage the method transfer process, ensuring seamless transition of analytical methods from development to quality control.
  • Oversee method validation activities, including the development and execution of validation protocols, analytical procedures, and reports.
  • Ensure that all method transfer and validation activities are conducted in compliance with regulatory guidelines, such as ICH, FDA, and EMA.
  • Collaborate with cross-functional teams, including R&D, quality control, manufacturing, and regulatory affairs, to facilitate method transfer and validation projects.
  • Troubleshoot and resolve technical issues related to method transfer and validation.
  • Provide technical expertise and guidance to junior scientists and laboratory staff.
  • Maintain accurate and detailed documentation of all method transfer and validation activities.
  • Stay current with industry trends and advancements in analytical chemistry and regulatory requirements.

Qualifications:

  • Ph.D. or Master's degree in Analytical Chemistry, Chemistry, or a related field.
  • Minimum of 5-7 years of experience in analytical chemistry, with a focus on method transfer and validation.
  • Strong knowledge of regulatory requirements and guidelines related to method validation and transfer.
  • Proven experience in developing and validating analytical methods for pharmaceutical products.
  • Excellent problem-solving skills and ability to troubleshoot complex analytical issues.
  • Strong leadership and project management skills.
  • Experience with a variety of analytical techniques, such as HPLC, GC, LC-MS, and spectroscopy.
  • Experience working in a cGMP environment.

Job Tags

Similar Jobs

Omnia Promotions

Business Management Consultant Job at Omnia Promotions

 ...opportunity for those few who embody an entrepreneurial spirit? Do you thrive in a fast-paced environment? Our entry-level Business Management Consultant opening is an excellent opportunity to join an industry leader and grow with us in an environment that is both challenging... 

Waves Express Car Wash

Express Car Wash Manager-in-Training Job at Waves Express Car Wash

 ...Start 2025 with a Splash! Join the Waves Express Car Wash Team as a Manager In Training! Kick off the new year with an exciting opportunity at Waves Express Car Wash! Recently named "Best of South Carolina" and "Best of the Upstate," we're searching for energetic, customer... 

Moubius LLC

Founder & Chief Executive Officer Job at Moubius LLC

 ...to accelerate their business growth (financing options available). Preferred Qualifications: Experience as a founder or CEO with 2+ years in an early-stage startup. Successful track record in fundraising and scaling a business. Strong vision for growing... 

Columbia University

Student Research Worker | Columbia University Job at Columbia University

 ...University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary We are seeking a part-time Student Research Worker at the School of Nursing who will work on projects focused on the influence of... 

Brawta Jamaican Jerk Joint

Apprentice Baker Job at Brawta Jamaican Jerk Joint

 ...Halifax, is looking for an enthusiastic Apprentice Baker to join our team! Position Details: Pay: Starting at $15.20/hour (minimum wage) Type: Part-Time Role: Assist in creating our delicious desserts, pastries, and authentic Jamaican patties....