Manager Chemical Development
GlaxoSmithKline
- Waltham, MA
- Permanent
- Full-time
- Provide process engineering support and scale up of small molecule drug substance and antibody-drug conjugate development programs.
- Collaborate and coordinate in cross-functional teams, both internally and with CDMOs (contract development and manufacturing organizations) to develop robust, scalable, cost effective and safe processes.
- Responsible for timely deliveries to support IND/IMPD enabling toxicology studies as well as manufacture of phase-appropriate cGMP drug substance.
- Work closely with external partners for the evaluation, technology transfer, scale-up and implementation of new processes and/or equipment.
- Troubleshoot new and existing product or process issues related to yield, quality, and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate.
- Develop and contribute to assessments for identifying, managing, and reducing product / process risk utilizing a variety of techniques including Technical Risk Assessments, Failure modes and effects analyses (FMEAs), and Hazard and Operability Studies (HAZOP).
- Create, review and/or approve technical documents including batch records, engineering / development reports, protocols and risk assessments.
- Construct, manage and analyze data from experiments to screen, optimize, and scale synthetic chemical processes.
- BS/MS in chemical engineering or related field science with 3+ years of experience in pharmaceutical research and development or biotechnology.
- Experience with ADC conjugation/ bio-conjugation
- Experience working in a virtual-CMC development/commercialization environment, collaborating with external partners.
- Experience in the development and/or manufacturing experience of highly potent active pharmaceutical ingredients (HPAPIs)
- Experience with technology transfers, technical risk assessments, and product control strategies.
- Experience with design of experiments (DoE) and modelling tools.
- Experience with purification unit operations such ultrafiltration/diafiltration (UF/DF) and chromatography
- Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential.