Scientist, Analytical Development
Exciting opportunity for experienced analytical development leader to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections. We are looking for talented people with a passion for having a direct impact on patients' lives in the near term.
This individual will work within the Process and Analytical Development (PAD) team on analytical method development in support of manufacturing and clinical laboratory testing. This Analytical Development Scientist will also work closely with the Quality team to facilitate the tech transfer of analytical methods.
- Work within the Process and Analytical Development team on all assay development, qualification, and validation activities in support of GMP and clinical laboratory testing
- Plan and execute all required analytical method development activities
- Coordinate tech transfer activities required for GMP testing and product characterization to the QC department
- Author technical documents, such as development reports, and qualification/validation protocols and reports
- Work with CMOs/CROs or external partners on method development, product characterization, and technology transfers
- Author and review sections of regulatory submissions such as INDs and meeting briefing documents
- Perform risk assessments and gap analyses for analytical methods and aim to enhance compliance and robustness
- Develop plans to identify, purchase, and qualify new equipment for testing methods
- Manage and coordinate individual projects, as assigned
- Serve as SME for assay troubleshooting and resolution
- Provide technical support for non-conformance investigations
- Ensure that analytical development facilities are maintained at a high standard of cleanliness and organization.
- Serve as the technical point of contact for outsourced assay vendors during assay development and validation processes
- May supervise analytical staff as the department grows
- Highly skilled in assay development, qualification, and validation
- Strong understanding of method validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance for testing of drug substances and drug products including requirements for clinical phase appropriate validation/qualification
- Ability to solve complex technical issues and drive to closure
- Skill in building and maintaining cross functional relationships across areas
- 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)
- Excellent communication skills; verbal and written; with various levels of internal and external organizations
- Ability to conduct technology transfers (e.g., to/from partners, academic institutions, or third-party contract laboratories)
- Master's or PhD in Microbiology, Molecular Biology, Chemistry, Biochemistry, Analytical Chemistry
- 5+ years of experience in the pharmaceutical and biotechnology industries
- Minimum of 2-3 years biopharmaceutical industry experience in analytical development and product characterization including tech transfer to QC laboratories both internally and externally
- Experience in typical analytical techniques 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 laboratory 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.