Remote Senior Scientist, Biologics Analytics (PhD)

IT Engagements, Inc.; Washington (District of Columbia); A distancia; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

IT Engagements, Inc. is seeking a Sr. Scientist in Biologics Analytical Development (PhD) for a remote role.

You will contribute to recombinant protein process development, analytical method development, and product characterization across microbial and mammalian systems. The role involves active collaboration with cross-functional teams and external partners to advance innovative biologic therapies. You will develop and validate analytical methods, review regulatory documentation, and support

Formación

• PhD in a scientific or engineering discipline required.
• Equivalent experience may be considered.
• Demonstrated technical expertise and independent thinking.

Responsabilidades

• Develop, optimize, and qualify/validate analytical methods for biologic products.
• Characterize recombinant proteins and protein conjugates using a variety of analytical techniques.
• Support upstream and downstream process development programs.
• Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.
• Review analytical data supporting GLP and GMP manufacturing activities.
• Review CMC sections of regulatory submissions.
• Contribute to patent application activities as appropriate.
• Independently analyze laboratory experiments.
• Collaborate with cross-functional teams and external partners.
• Author and approve technical reports, protocols, and scientific documentation.
• Maintain compliance with applicable regulatory and quality requirements.

Conocimientos

Problem solving

Analytical abilities

Communication skills

Interpersonal skills

Collaboration

Educación

PhD in a scientific or engineering discipline

Equivalent experience considered

Herramientas

Waters Empower

MS Word

MS Excel

PowerPoint

Descripción del empleo

IT Engagements, Inc. is seeking a Sr. Scientist in Biologics Analytical Development (PhD) for a remote role.

You will contribute to recombinant protein process development, analytical method development, and product characterization across microbial and mammalian systems. The role involves active collaboration with cross-functional teams and external partners to advance innovative biologic therapies. You will develop and validate analytical methods, review regulatory documentation, and support