Exciting opportunity for experienced Process Engineer to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections. This position will work within the Process and Analytical Development (PAD) department. This Process Engineer will support scale up of manufacturing processes and troubleshoot manufacturing issues at any stage of development while working closely with manufacturing, analytical and quality leadership to ensure processes are robust.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
- Design and conduct process development activities for scaling of APT's bacteriophage manufacturing process. This includes bioreactor fermentation, batch harvest, filtration clarification, tangential flow filtration, and purification.
- Will be responsible for set-up and execution of experiments on development manufacturing equipment.
- Will determine process requirements. Helps design, install, and commission new processes and equipment into upstream and downstream manufacturing process. Will be the Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment in assigned area(s).
- Performs troubleshooting, corrections, and process performance optimization as appropriate for development.
- Monitors bioprocess equipment performance. Identifies equipment issues and performs troubleshooting, corrections, and process performance optimization as appropriate for development.
- Track in process metrics across manufacturing runs, will identify trends and opportunities for improvement.
- Will work closely with Process Development scientists and Manufacturing leadership
- Prepares comprehensive reports documenting experimental conduct and results. Contribute to internal technical reports to support regulatory filings.
- 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, including those outsourced to third party vendors
Please note this job description is not an all-encompassing and comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
- Experience with bioreactors, fermenters and various filtration and purification techniques required
- Excellent communication skills with demonstrated ability to interact with and build relationships at many levels of organizations to accomplish objectives
- Strong project management skills and adept at working collaboratively with cross functional teams and third-party vendors
- 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)
- Experience conducting technology transfers (e.g., from internal partners or academic institutions or to a third-party contract manufacturing organization)
- Other duties as needed.
- Bachelor of Science, Master's or PhD in Chemical or Biomedical Engineering
- 5+ years of experience in the pharmaceutical and biotechnology industries
- 3+ 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 processes is preferred
Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.
Candidates will be provided a copy of the physical/mental/environmental requirements upon request
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.
*Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through the Adaptive Phage Therapeutics Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Adaptive Phage Therapeutics, and no fee/payment will be paid. Recruiters interested in working with Adaptive Phage Therapeutics can submit their information to email@example.com and we will contact you if needed.