Scientist, Research Scientist, Biotech Research

Company
. Eliksa Therapeutics is a clinical-stage biotechnology company based at the Pennsylvania Biotechnology Center in Doylestown, PA.

Our lead candidate, ELK-003, is a topical biological eye drop being developed to prevent and treat corneal abrasions associated with epidermolysis bullosa (EB). There is no approved therapy for the ocular manifestations of EB. ELK-003 is a proprietary mixture of proteins derived from human amniotic fluid that modulates cell attachment and proliferation. An investigator-sponsored Phase 1/2a trial in EB patients is underway in partnership with DEBRA Chile (NCT).

We are funded by a consortium of VCs, EB-related foundations, and the U.S. Department of Defense.

Role Summary
. This role owns the analytical methods and documentation for ELK-003, built to withstand regulatory review. You will develop, run, qualify, and validate the methods at the bench, author the SOPs and scientific reports, select and manage the contract labs for work we can't do in-house, and draft the CMC content submitted to FDA. You will work directly with the CEO and alongside our scientists

We move fast and need someone who can hit the ground running from day one.

Role Responsibilities

• Own the analytical development function for ELK-003 end to end, from strategy through bench execution to documentation, with emphasis on identity and potency.
• Develop, qualify, validate, and document ELISA and multiplex immunoassays for identity and characterization of a multi-protein drug substance, including matrix effect verification.
• Develop and qualify orthogonal physicochemical methods: CE-SDS, SDS-PAGE, total protein, MS-based proteomics, SEC-HPLC, RP-HPLC, and ion exchange.
• Author method qualification and validation protocols and reports, SOPs, and product specifications to a standard that supports an IND.
• Partner with our potency scientist on potency assay strategy, development, qualification, and validation.
• Establish lot-to-lot consistency and comparability approaches appropriate to a human-source-derived biologic.
• Select, scope, and manage external labs for LC-MS/proteomic characterization and GMP release testing, and critically review the data they return.
• Write the analytics CMC content for the pre-IND briefing document and IND Module 3.

Qualifications

Required

• PhD in biochemistry, analytical chemistry, protein chemistry, or a related field, with 6+ years of industry experience. An MS with 10+ years of directly relevant industry experience will be considered.
• Hands-on experience developing, qualifying, and validating immunoassays for a regulated product. Running commercial kits is not the same as developing, qualifying, and validating a method, and this role requires the latter.
• Direct experience authoring method qualification, validation protocols and reports included in a BLA.
• Working proficiency across the protein analytical toolkit: CE-SDS, SDS-PAGE, MS-based proteomics, immuno-based proteomics, HPLC (SEC, RP, IEX), immunoassays, and total protein quantitation.
• Practical command of ICH Q2(R2), ICH Q14, Q6B, and phase-appropriate method qualification and validation. You should know what a Phase 2 IND actually requires, and what it does not.
• Willing and able to work at the bench. This is a hands-on role in a small lab.

Strongly Preferred

• Experience with plasma-derived or other human-source-derived multi-protein biologics: immunoglobulins, albumin, fibrin sealants, clotting factors, or comparable products
• Experience defining and controlling a drug substance that is an inherently heterogeneous mixture rather than a single recombinant molecule
• Experience with CBER-regulated products
• Track record selecting and managing contract analytical laboratories
• Experience in a startup
• Ophthalmic product or formulation experience

Compensation

Competitive and commensurate with experience. Title may be adjusted upward for an exceptional candidate.

Eliksa Therapeutics, Inc. is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, sexual orientation, religion, national origin, age, disability, or any other characteristics protected by applicable federal, state, or local law.

Recruitment and staffing agencies:
Eliksa Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies is strictly prohibited and no fees will be paid.