Senior Bioassay & Impurity Method Scientist

BioCT Innovation Commons; New Haven (CT); On-site; USD 138,392 - 207,590; Full time

Benefits offered by this job

Health benefits including medical, prescription drug, dental, and vision

401(k) retirement plan

Paid vacation and holidays

Job summary

BioCT Innovation Commons is seeking a Development Scientist III in New Haven, CT, to lead the development, qualification, and optimization of bioassays essential for biotherapeutic product testing. The role includes method development and the creation of regulatory documents.

Ideal candidates will hold a Ph.D. or master's degree in a relevant field and possess at least 6 years of experience in analytical method development. A collaborative approach, strong scientific knowledge, and exceptional communication skills are required.

Qualifications

• Ph.D. with 6+ years in analytical method development.
• Experience in method qualification in biotech or pharmaceutical.
• Strong knowledge of cGMP and regulatory standards.

Responsibilities

• Develop and qualify bioassays for therapeutic proteins.
• Author SOPs and draft regulatory filing documents.
• Lead scientific problem-solving efforts across functions.

Skills

Analytical method development

ELISA binding assay

Enzymatic assay

Cell-based assay

Problem-solving skills

Interpersonal skills

MS Office proficient

Education

Ph.D. or master's degree in Biochemistry, Molecular & Cellular Biology or related

Tools

MS Office Suite

SoftMax Pro

Job description

BioCT Innovation Commons is seeking a Development Scientist III in New Haven, CT, to lead the development, qualification, and optimization of bioassays essential for biotherapeutic product testing. The role includes method development and the creation of regulatory documents.

Ideal candidates will hold a Ph.D. or master's degree in a relevant field and possess at least 6 years of experience in analytical method development. A collaborative approach, strong scientific knowledge, and exceptional communication skills are required.