Senior Manager, Analytical Chemistry
$135,000–$215,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Direct the development, optimization, validation, and transfer of analytical procedures for testing in-process yield, purity, key intermediates, and impurities. Participate in cross-functional task forces to coordinate analytical activities at CMOs and CROs, while assessing and selecting vendors, soliciting quotes, and finalizing contracts. Contribute to remediation of deviations, implementation of corrective and preventive actions, and change controls. Author and review regulatory CMC submissions including method validations, reference standards, batch analyses, characterization, stability, and specification sections. Identify and organize analytical documents to support robust method life-cycle management. Assess and select CRO/CMOs, solicit quotes and finalize contracts with finance and legal. Contribute to fulfilment of pre- and post-approval commitments and annual product reviews.
Required Qualifications
- Minimum of Bachelor's degree with over 7 years' experience or Master's degree with over 5 years' experience in analytical method development or quality control in the pharmaceutical industry
- Experience in analytical techniques for monitoring yield and purity during organic synthesis
- Knowledgeable in the testing of raw materials, excipients and components
- Familiarity in procedures for characterization, qualification and management of intermediate and impurity standards
- Authorship and/or review of analytical method development, validation and transfer documents
- Demonstrated knowledge and experience in the interpretation and application of ICH, compendial, cGMP and pharmaceutical best practices
- Familiarity in qualification of trace impurities, including extractables, leachables and nitrosamines
- Well versed in analytical and characterization procedures, for example, HPLC, GC, MS, elemental impurities and moisture analyses
- Competent in the use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems
- Excellent interpersonal, organizational, problem-solving, customer service and communication skills
- Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of scientific quality and compliance
- Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs
- This role may involve some travel
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