Sr. Scientist, Analytical

Job Title: Sr. Scientist, Analytical

Job Number: 34039

Location: Boston, MA

Job Description

We are seeking an Analytical Development Bioassay Scientist to be responsible for developing cell-based and ELISA potency assays for product testing/characterization for our clients Boston-based lab. This individual will be an important member of the TechOps team, responsible for developing assays and testing various molecules at all stages of product development. This role will report to the Vice President of Bioanalytical Development.

Responsibilities

Key Responsibilities

• Develop cell-based bioassays and ELISAs suitable for validation and transfer to GMP testing labs
• Build out/equip lab to establish robust bioassay/potency testing capabilities in-house (non-GMP)
• Perform potency testing of protein-based drug candidates to support development activities, stability studies, and molecule characterization 
• Oversee the qualification/validation and transfer of assays
• Interpret bioassay data, troubleshoot assays and take part in lab investigations as needed
• Author study protocols and reports 
• Work closely with Manufacturing & Development partners within TechOps, as well as external stakeholders, to execute bioassay/potency testing activities according to program needs

 
Ideal Candidate

• Advanced degree, or equivalent experience, in a relevant discipline (e.g., cell biology, or related field)
• 5+ years of experience developing cell-based bioassays and ELISAs used to quantitatively test the potency of complex biological molecules
• Expertise/competence with additional analytical techniques such as HPLC, spectrophotometry, and capillary electrophoresis is desired
• Ability to work full time on-site at our Boston-based laboratory with minimal direct supervision 
• Excellent communication skills with an ability to collaborate effectively across functional lines
• Ability to work and multi-task in a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Ability and willingness to travel up to eight times a year

Required Skills