Scientist/Senior Scientist, Bioanalytical Sciences
We are seeking a detail oriented and highly motivated Scientist/Senior Scientist to join the Bioanalytical Sciences team at Amunix Pharmaceuticals.
The successful candidate will be responsible for developing, performing and outsourcing Cell-Based and/or Ligand Binding Potency Assays (e.g. ELISA) in support of CMC activities to help advance research, pre-clinical, and clinical stage programs. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
- Develop, optimize and outsource complex cell-based assays for assessing the potency of XTENylated molecules and relevant metabolites.
- Help manage transfer and oversight of potency method qualification/validation and stability and lot release sample analysis for GMP drug substance and drug product lots at selected CROs.
- Perform in-house potency characterization of manufactured lots, stability and in-process samples (in-house and outsourced production).
- Document all activities in an electronic notebook, compile data and analyze results in a timely fashion.
- Present data in group settings to update other teams on progress of assay development.
- Write development reports and contribute to writing of relevant sections in IND/ IMPD submissions to regulatory authorities
- Perform routine equipment maintenance, calibrations, and verifications as needed.
- Work cross-functionally with members of other departments to complete tasks when required.
- A minimum of a Bachelor's degree in a scientific discipline with 8+ years of work experience, Master’s degree with 6+ years or Ph.D. with 2+ years of work experience. Equivalent experience may be accepted.
- Experience developing Cell-Based and Ligand Binding Potency Assays is a must.
- Experience and understanding with successful implementation of bioanalytical method validation per current regulatory guidance and expectations is a must.
- Experience with transfer of assays internally and externally is desirable.
- Experience working in a GMP or GLP environment is desirable.
- Ability to work in a fast-paced, dynamic environment with effective time-management skills.
- Self-motivated to carry out both new and routine tasks.
- Must be willing to work as part of a team and demonstrate good interpersonal skills.
- Proficient working with SoftMax Pro (PLA), Microsoft Word, Excel, and PowerPoint.
- Past experience with electronic notebook systems and relevant potency analysis techniques and software a plus.
Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients’ lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality. Amunix is currently located in South San Francisco.
Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.
HOW TO APPLY
To apply, please submit your cover letter and resume to firstname.lastname@example.org