Endolytix
Formulation Scientist
Endolytix, Beverly, Massachusetts, United States
Endolytix Technology Inc. is a well-funded startup biopharmaceutical company developing novel biological antibacterial therapeutics for a critical unmet need to transform the lives of patients with the most difficult infections to treat due to antibiotic resistance, drug toxicities, access, and reemergence post-therapy. We are in the Preclinical stage of development focused on scale up process development for our lead drug formulation that consists of Enzymes encapsulated into liposomes. We’re seeking a highly skilled hands-on professional scientist to join a fast-paced biological formulations team at Endolytix. The successful candidate will provide expertise in formulations of biologicals as therapeutics. Responsibilities will include multiple aspects of formulations, protein biochemistry, and analytics to drive development novel medicines for the treatment of life-threatening bacterial infections for which there are no currently accepted treatments and very poor success rate for the standards of care. Job Responsibilities · Formulation of enzymes in liposomes to optimize scaled-up process development · Running of stability studies · In house scaled up process development from 1 ml to 1 Liter preparation for pre-IND submission · Working with CDMOs to transfer and support process development · Biophysical characterization of proteins and liposomes using spectroscopy tools such as DLS, MADLS, UNCLE derived Tm and Tagg, gel densitometry, and FFF-MALs · Conceptual design, execution, and documentation of biochemical assays to characterize enzymes in and out of encapsulated liposomes · Responsible for generating high quality biochemical and biophysical data for particle analysis and stability · Clear presentation of research outcomes and recommendations to multi-functional teams · Perform drug purifications using Tangential Flow Filtration (TFF) and other methods · Develop and collaborate externally on aerosols development · Leadership for junior formulations staff Required Qualifications · Minimum of 5 years of pharma or biotech experience · BS, MS, or Ph.D. in Biochemistry, Biophysics or related field · Proven experience in developing lipid-based delivery vehicles of encapsulated biological API · Proven experience in stabilizing biological formulations for improved efficacy · Demonstrated ability to solve difficult problems in assay development and formulation science · Relevant biological drug discovery experience working in a collaborative environment · Startup company experience · Effective communication both verbal and written for collaboration throughout the company Preferred Qualifications · Small scale manufacturing experience for non- and GLP drug product · Experience taking drugs from discovery through subsequent drug development phases including animal studies, manufacturing, and IND-submission · Experience working with liposomes, micelles, nanoparticles or related technologies · Experience with statistical software such as JMP and experience running DOE · Demonstrated flexibility to thrive in a team-oriented, fast paced, technically challenging drug-hunting culture · Experience with GMP manufacturing of biologicals Equal Employment Opportunity Policy It is the policy of Endolytix Technology, Inc. (“Endolytix”) to provide equal employment opportunities to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex (including sexual harassment and pregnancy discrimination), sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Endolytix will provide reasonable accommodations for qualified individuals with disabilities.