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Sr. Scientist, Analytical Development
4 months ago
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.
Job Summary:
Scorpion Therapeutics is seeking a highly skilled and motivated Senior Scientist, Analytical Development to join our CMC team. The Senior Scientist will play a key role in advancing our pipeline of novel cancer therapeutics by leading the development and implementation of analytical methods to characterize drug candidates and support formulation development.
Key Responsibilities:
- Lead the design, development, and implementation of analytical methods for the characterization of small molecule drug candidates, including but not limited to HPLC, LC-MS, CE, spectroscopic techniques, and other relevant methodologies.
- Oversee method validation studies in compliance with regulatory guidelines (e.g., ICH, FDA) and facilitate the transfer of analytical methods to internal and external stakeholders, including contract research organizations (CROs) and manufacturing partners.
- Design and execute stability-indicating studies to evaluate the stability profile of drug substances and drug products under various conditions, ensuring regulatory compliance and product quality.
- Collaborate closely with other functions, including Chemical Development, Formulation Development, Regulatory Affairs, and Quality Assurance, to provide analytical support and contribute to the overall success of development programs.
- Analyze experimental data, prepare technical reports, and maintain detailed documentation in accordance with internal SOPs and regulatory requirements. Ensure data integrity and accuracy throughout the analytical development process.
- Identify opportunities for process innovation and improvement of analytical development workflows to enhance efficiency and productivity.
- Ensure compliance with relevant regulations and guidelines governing analytical methods, including GMP/GLP requirements, and actively participate in quality assurance activities, such as internal audits and regulatory submissions.
Qualifications:
- PhD or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or related field with a minimum of 3-5 years (PhD) or 8 years (Master's) of relevant industry experience in pharmaceutical or biotechnology settings.
- Proven expertise in analytical method development and validation for small molecule therapeutics, with hands-on experience in a variety of analytical techniques and instrumentation.
- Strong understanding of regulatory requirements (e.g., FDA, ICH) governing analytical development and quality control in drug development.
- Excellent problem-solving skills, attention to detail, and ability to work effectively in a fast-paced, multidisciplinary team environment.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with colleagues at all levels of the organization.
- Experience with stability studies, formulation development, and knowledge of physico-chemical characterization techniques is desirable.
- Demonstrated track record of scientific innovation, leadership, and project management skills is a plus.
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
