Drug Process Development, Senior Engineer
Compensation: $101,640.00 - $147,870.00 /year *
Employment Type: Full-Time
This position provides technical and program management leadership to collaborate with Avedro s CDMOs for process development and scale-up of drug fill/finish processes from concept through commercialization, launch and beyond. He/she will support CDMOs with manufacturing equipment characterization, process characterization, technical transfer, process engineering, analytical methods, and product lifecycle management. The candidate s responsibilities include supporting fill finish site selection process, defining equipment user requirements, factory acceptance tests, functional characterizations, and process performance qualification for formulation and fill/finish. Additionally, this role will lead project planning and authoring of Tech Transfer plans and reports role that requires close collaboration with small multifunctional teams to meet program deliverables.
Primary Responsibilities Include
- Acts as single Point of Contact (POC) for Avedro to provide expertise/knowledge of clinical & commercial manufacturing site capabilities and practices in drug substance, storage, formulation, filling of vials/syringes/devices, and inspection. Provide oversight to contract manufacturing of drug product and drug substance manufacturing including compounding, filtration, and fill/finish, across a diverse range of unit operations.
- Work with external partners to support development, qualification, supply, and cGMP manufacture / packaging / labeling. Creates equipment user requirements, conducts FAT, Process Characterization and Validation in all sterile fill finish processing areas
- Maintain database containing pedigree of all GMP manufacturing and development activities (i.e., raw material lot # s, assay, yield, deviations, and other critical attributes).
- Maintain critical quality attributes, in-process and release data tracking and trending analysis as well as in-process equipment parameter tracking and trending analyses.
- Provides Engineer in plant oversight to GMP related activities during fill/finish run at CDMO.
- Assist in execution of formalized process risk assessment to support registration and submission.
- Lead fill-finish tech transfer projects and scale up activities. Work with cross-functional teams during development and pilot scale batch production, engineering batches, validation campaigns, process changes, and scale-up/transfer trial at new and/or existing CMOs.
- Lead cross-functional tech transfer teams using Project Management methodologies, track project status, provide routine updates to leadership and perform risk identification and mitigation
- Use experience in Process Development to provide resolution for technical challenges that may be encountered during Tech Transfer
- Author Tech Transfer Master Plans and Tech Transfer Summary Reports
- Maintain a high level of compliance and efficiency during tech transfers and at CMOs to drive the organization to world-class manufacturing standards
- Work with R&D drug development team in the early stages of drug development to ensure manufacturability at commercial scale
Education and Skills Requirements
- Bachelor s Degree in Chemical or Pharmaceutical Manufacturing Engineering or higher required.
- Expert working knowledge of aseptic syringe filling, packaging and labeling for parenteral drugs in a regulated environment is required.
- Experience with GMP manufacturing processes, technology transfer, risk assessments, and change controls during a scale-up/commercialization effort is required
- Minimum 5-7 years experience technical and/or manufacturing role for pharmaceuticals with 3-5 direct experience in a Technology Transfer/Validation role for multiple products/CMOs
- Understanding of FDA/EU GMP Requirements and ISPE Tech Transfer
- Equipment installation, qualification and validation (IQ, OQ, PQ, FAT, SOPs)
- Expertise in GMP/ISO verification and validations of manufacturing processes (cGMP)
- Batch record and SOP writing and review. Investigations, deviations, OOSs, and change control
- Excellent organizational and program management skills. Proficient in Excel and Microsoft Project.
- Ability to work independently and in team environments
- Ability to travel domestic and international 30% for technical transfer and CDMO oversight.
- Excellent communicator in both written and verbal methods
Associated topics: bioengineer, design, develop, engineer, manufacturing, manufacturing engineer, mechanical, mechanical engineer, process engineer
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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