Senior Scientist - Analytical Development
- Location: Baltimore, MD
- Working situation: On-site
- Level: Senior Scientist
Our client, a growing pharmaceuticals firm, is working to produce innovative drug therapies with multiple products in pipeline from pre-clinical to the commercialization stage. With a focus in pioneering therapies that address unmet medical needs, our client is proud of their continuous dedication to research and development. As they expand their portfolio and enter new therapeutic areas, we are seeking a highly skilled and motivated individual to join their team.
The Senior Scientist - Analytical Development will lead a project team, by providing expertise in analytical development for intermediate and active pharmaceutical ingredient manufacturing operations, from all phases of the drug development cycle. You be a leader on the analytical development team, overseeing the design, optimization, and validation of analytical methods crucial for characterizing drug candidates and ensuring their quality and safety. Your expertise will drive the successful progression of drug development programs, making a significant impact on patients' lives worldwide.
The Senior Scientist - Analytical Development will:
- Supervise molecule characterization, method validation, method development, and method transfer ensuring drug efficacy
- Define and plan out strategies for early- to late-stage development in the drug product lifecycle
- Develop and optimize a wide range of analytical methods, such as chromatography, mass spectrometry, spectroscopy, and others, for the characterization of drug substances and drug products
- Lead cross-functional project teams to drive and execute CMC development plans
- Work closely with the regulatory affairs team to prepare and review sections of regulatory submissions related to generics projects, supporting investigational new drug (IND) applications and new drug applications (NDAs).
- Partner with CMC and Quality, to support cGMP manufacturing
The Senior Scientist - Analytical Development has the following qualifications:
- Master's degree with 6+ years of industry experience
- 4+ years of experience in contributing to CMC efforts from Phase I to Phase III (desired)
- 3+ years of experience in small molecule analytical development (desired)
Company Benefits:
- Excellent PTO package
- Inviting and vibrant team culture
- Long term incentives in the terms of equity or stock at this level
- Competitive 401K program, health insurance, and HSA accounts
If you're fuelled by a burning passion for innovation, a relentless pursuit of analytical excellence, and a desire to constantly push the limits of drug development, we invite you to seize the opportunity and apply for this exceptionally rewarding position today!
