Analytical Development Scientist/Sr. Scientist

With over 30 years of expertise, Gannet BioChem is a leading specialty CDMO specializing in the development, scaling, and manufacturing of polyethylene glycol (PEG) reagents—essential components in advanced biopharmaceutical and therapeutic products. Operating from a state-of-the-art 124,000 sq. ft. FDA-inspected facility in Huntsville, Alabama, Gannet BioChem delivers end-to-end GMP production, supporting clinical and commercial therapeutics. With a highly experienced team, flexible production capabilities, and a commitment to quality, Gannet BioChem provides reliable, innovative solutions to meet the evolving needs of the global biopharmaceutical industry. For additional information and to submit a resume, please visit GannetBioChem.com or follow us on LinkedIn.

Key Responsibilities

• The Scientist/Sr. Scientist participates and occasionally leads developing the recombinant protein production process.
• Performs analytical method development and product characterization of recombinant proteins and conjugated proteins derived from microbial and/or mammalian expression systems.
• Performs day-to-day hands-on operations for development and optimization of analytical methods. Characterizes protein molecule and complex protein conjugates using various analytical methods, i.e. HPLC, CE, mass spectrometry, Biacore, etc.
• Qualifies analytical methods phase appropriately.
• Provides analytical support for upstream and downstream process development.
• Oversees the activities at CROs for advanced characterization.
• Involved in analytical method transfer and qualification/ validation at CROs/CMOs.
• Oversees analytical results to support GMP production.
• Reviews and/or authors the CMC sections of regulatory filing documents.
• May participate in the development of patent applications.
• Writes and/or approves complex reports and protocols.
• Maintains knowledge of regulatory compliance requirements.
• May assist with implementing organizational systems, identifying capital equipment, and projecting resource requirements.
• May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements.

Qualifications

A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted. A minimum of 4 years work experience in a biotechnology/pharmaceutical industry, preferably in analytical development, is required.

Post-doctoral work may serve as experience.

Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.

Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.

Excellent written and verbal communications and teamwork skills are essential. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Must possess good oral and written communication skills.

Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities.

Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required.

Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are a plus. Previous management skills are a plus. Must be willing to work as part of a team.