Job at a glance
CambrexAnalytical Development, Group LeaderUS-IA-Charles CityJob ID: 2026-5015Type: Regular Full-Time# of Openings: 1Category: Analytical DevelopmentCambrex - Charles CityOverview The Group Leader of Analytical Development will supervise day to day laboratory activities while providing leadership in the development, validation, transfer, and verification of the analytical methods used on site. This supervisory role will be focused on training of staff, career development support, project management, customer interaction, provide management oversight project results reporting, team collaboration, plant support work and bench to analytical technology transfer.ResponsibilitiesSafely and efficiently managing a group of 5-8 direct reports with varying levels of experience and degrees to develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.Effectively and professionally communicating project status to internal and external clients during weekly teleconferences and email correspondence.Investigating and solving analytical technical issues.Assisting with or leading efforts to transfer documented analytical methods to Quality Control and Process Support departmentsProviding guidance and/or project leadership for cross functional project teamsProviding guidance to laboratory personnel on safe laboratory practicesPerform analytical chemistry assays based on new and existing methodologies and qualify reference materials.Training staff on analytical techniques and instrumentationParticipating in the evaluation of new business opportunitiesMaintaining laboratory notebooks documenting work and writing technical reports to document analytical methodsMaintain compliance with GMP SOPs and DEA regulationsCoordinate off-site testing as necessaryParticipation in design/execution in R&D initiatives Grow/maintain connections with dependent departments Qualifications / SkillsDemonstrated success in validating analytical methods to support production in a safe, efficient and economically viable mannerMastery of compliance requirements within cGMP, safety and regulatory environments requiredStrong operational knowledge of analytical instrumentation including HPLC, GC, LC/MS, FTIR, UV-VIS, NMR and data stations requiredExperience in pharmaceutical laboratory experience requiredFamiliarity with cGMP regulations required.Working knowledge of Empower 3 beneficialQualifications4 year degree in Chemistry, with analytical emphasis.
Advanced degree beneficial8 or more years of industrial experience in a method development and validation role with a focus on small scale pharmaceutical method validation PI287031732