Sr Scientist, CMC Process Development

The Position

The Senior Scientist works in the Chemistry, Manufacturing, and Controls Group focusing on process validation and other aspects of small-molecule and macromolecule process development. This is an ideal position for an individual with an organic chemistry background who has an interest in projects related to novel technology in synthesis, purification and characterization of oligonucleotides and bioconjugates, with a focus on process validation.

Responsibilities

• Perform synthesis, purification, and characterization of small molecules and macromolecules with a focus on developing robust procedures.
• Identify improvements to existing synthetic routes and execute novel chemistries which offer safety and manufacturability benefits, independently and/or collaboratively with a team.
• Coordinate with intra- and inter-departmental staff to support internal scale-up campaigns.
• Identify, characterize, and develop control strategies for potential drug substance impurities.
• Design and execute process optimization activities to establish proven acceptable ranges around critical process parameters in support of regulatory filings.
• Write procedures to facilitate technology transfers.
• Utilize analytical techniques to characterize products and product-related impurities.
• Prepare technical reports, presentations, policies and procedures, and contribute technical expertise to regulatory filings.
• Present data and technical information to intra- and inter-departmental colleagues and management.
• Maintain a well-documented laboratory notebook.
• Track project deliverables and provide updates on progress to team members, management, and cross-functional teams.
• Provide leadership, technical guidance and development to junior scientists.
• Demonstrate expertise and the ability to apply advanced scientific principles, theories and concepts to a broad range of problems and develop innovative solutions related to drug substances and process characterization/validation.
• Critically analyze and interpret data/results and outcome of experiments and propose appropriate pathways and remediation to management.
• Embrace cGMP requirements for all work associated.
• Demonstrate flexibility with changing priorities.

Requirements:

• PhD. with at least 2+ years, or M.S. with at least 7+ years, or B.S. with at least 10+ years of relevant industrial or academic experience, in Chemistry or related field
• Excellent verbal and written communication skills
• Excellent problem-solving skills
• Expertise in synthetic organic chemistry and relevant analytical technology

Preferred:

• Direct experience with synthetic process development, oligonucleotide workflows, solid phase synthesis, or bioconjugation
• Prior experience with regulatory writing and filings
• Prior experience and familiarity with GLP/GMP regulations and process validation
• Experience with small-molecule or macromolecule analytical techniques (e.g., HPLC, UV-Vis spectrophotometry, mass spectrometry, etc.)
• Experience with JMP or similar statistical analysis software
• Be able to perform complex math functions and be able to draw and interpret graphs and charts