Senior Scientist, Analytical Development

Keros Therapeutics•Lexington, MA

About The Position

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary This role will focus on the design, development, and successful transfer of cell-based and ligand-binding potency assays to support the characterization, release, and stability testing of Keros’ pre-clinical and clinical phase products. The ideal candidate will have deep expertise in potency and bioassay development with strong analytical skills that can be applied across other areas of analytical development. The candidate will collaborate effectively within cross-functional teams, including colleagues from Research, Quality Control, Process Development, and MSAT to promote successful transfer of analytical release assays to CDMO’s.

Requirements

Demonstrated expertise in the development, validation, and lifecycle management of cell-based potency assays, including experience with relevant techniques and technologies.
Robust understanding of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays
Demonstrated ability to communicate complex data clearly and concisely, with excellent scientific writing skills, strong attention to detail, and a proven track record of effective cross-functional collaboration.
PhD 2+, MS 7+, BS 10+ years related experience in the pharmaceutical field, preferably with mAbs and Fc-fusion proteins, and a degree in analytical science, bioanalytical science, or preclinical development.

Nice To Haves

Expertise in the generation and/or use of analytical cell lines with stable expression of targets of interests and/or reporter constructs is preferred
Experience with analytical techniques such as chromatography, capillary electrophoresis, is desired
Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings is preferred

Responsibilities

Develops and optimizes cell-based functional and ligand-binding assays for potency determination of Keros protein therapeutics
Supports the method development, qualification, and validation of methods at CMO or CRO for GMP biotherapeutic manufacturing, including the review and approval of protocols and reports
Provides in-house analytical testing capabilities for development activities
Define potency strategy and method design based on clinically relevant mechanisms of action (MoA), targeted method performance, and transferability
Apply knowledge of regulatory guidelines (ICH, USP chapters) to ensure compliance in bioassay development and validation
Independently resolves complex technical challenges and implement innovative solutions.
Serves as a technical resource and mentor, training colleagues across multiple technologies.
Stays current with emerging technologies, industry trends, and regulatory expectations related to potency methods for biologics
Reviews, interprets, and communicates complex data clearly to functional leadership and cross-functional teams.
Leads analytical technology transfer activities internally and externally, building and maintaining key vendor relationships.
Develop project strategies within Analytical Development and across functions, guiding team members to successful execution.
Author technical reports, regulatory filing sections, and scientific publications as appropriate.
Ensures that all developed methods are compatible with quality requirements including regulations, policies, applicable guidelines, and procedures.