Scientist, Process Development
Exciting opportunity for experienced process development leader to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections.
This individual will develop and scale-up bacteriophage amplification and purification processes and transfer those processes to GMP manufacturing. The scientist will support and troubleshoot manufacturing issues at any stage of development while working closely with manufacturing, analytical and quality leadership to ensure processes are robust.
- Conduct process development activities and is responsible to set-up and run experiments on development manufacturing equipment
- Design and conducts well controlled experiments with an understanding of Quality by Design approaches
- Prepare comprehensive reports documenting experimental conduct and results
- Work closely with analytical resources to analyze experimental data and provide recommendations for future experiments
- Work closely with formulation experts to continue development and refinement of final drug formulations
- Prepares comprehensive reports documenting experimental conduct and results
- Participate in the assembly, operation, disassembly, and cleaning of equipment
- Prepare draft SOPs and batch records for use by manufacturing
- Assist manufacturing with validation of new processes and provides technical support
- Manage and coordinates individual projects, as assigned
- Serve as SME for process troubleshooting and resolution
- Ensure that process development facilities are maintained at a high standard of cleanliness and organization
- Serve as the technical point of contact for outsourced vendors
- May supervise process development staff as the department grows
- Experience with bioreactors, fermenters and various filtration and purification techniques required
- Experience with analytical method development desired
- Excellent communication skills with demonstrated ability to interact with and build relationships at many levels of organizations to accomplish objectives
- Ability to manage multiple priorities with a sense of urgency to meet timelines
- Adaptability to change
- Working knowledge of US and global regulations for GMP manufacturing of drug substances and drug products including requirements for clinical phase appropriate validation/qualification.
- Demonstrated skill with quality management systems (e.g., Deviations, CAPAs, Change Management)
- Ability to conduct technology transfers (e.g., from internal partners or academic institutions or to a third-party contract manufacturing organization)
- Bachelor of Science, Master's or PhD in Chemical or Biomedical Engineering
- 10+ years of experience in the pharmaceutical and biotechnology industries
- 5+ years demonstrated experience in upstream and downstream process development including tech transfer to GMP manufacturing
- Experience in typical unit operations utilized in manufacturing of microbiology and virology products
- Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint)
- Experience in design, qualification, and start-up of manufacturing facilities preferred
Compensation: Salary is industry-standard and is commensurate with experience.
APT is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. At APT, we don't just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our therapeutics, and our community.