Manufacture Specialist Technical Operations and CMC

Aspyrian Therapeutics is looking for a Manufacture Specialist who will be pivotal for developing cell culture and conjugation in support of Aspyrian's first-in-class photoactivatable monoclonal antibody conjugates.  In addition, this role will be responsible for internal material supply to support the development and discovery programs.  The ideal candidate will have a minimum of 10 years of Biologics development and manufactured experience.  Advanced degree preferred, MS and/or PhD. desired. 

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 0018-CG


CLINICAL TRIAL MANAGER

Aspyrian Therapeutics is looking for a Clinical Trial Manager who will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership. The ideal candidate will have 7 + years of experience with site monitoring and study/ CRO vendor management with previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations. Please note that this job will require travel up to 50% US and ex-US, depending on trial activities.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 0001-LF


RESEARCH ASSOCIATE, PHARMACOLOGY

Aspyrian Therapeutics is looking for a Research Associate who will be responsible for supporting Aspyrian’s preclinical oncology research program in multiple ways. In this role, the Research Associate will broadly contribute to the multidisciplinary research team by executing a variety of assays involving in vitro cell biology, immunoassays, and ex vivo tissue processing and staining. Furthermore, the Research Associate will maintain and upscale cell lines for allografts and xenografts as needed. The ideal candidate will have a B. S. or M. S. plus minimum 2+ years of experience in an academic or industry laboratory setting.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 0001-JF


REGULATORY AFFAIRS HEAD, ONCOLOGY

Aspyrian Therapeutics is looking for a Regulatory Affairs Head who will be a key leader of our management team. The Regulatory Affairs head will work directly with Aspyrian’s functional leaders and external consultants and will lead the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.  The candidate should have a B.S./M.S. with at least 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization.  Responsibilities will include executing US /OUS regulatory project plans in collaboration with Aspyrian management, clinical, CMC and device groups as well as regulatory consultants, and CROs. Additional responsibilities include managing and overseeing all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory FDA, EMA and PDMA applications, safety, amendments, and IND safety and annual reports

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 15MGG


RESEARCH ASSOCIATE/SENIOR RESEARCH ASSOCIATE, ANALYTICAL CHARACTERIZATION

Aspyrian Therapeutics is looking for a RA/SRA who will be a key member of the Analytical Characterization team and is responsible for supporting Aspyrian's internal laboratory-based analytical characterization capabilities. The candidate should have a B.S. or equivalent in life sciences with at least 2-5 years related industry experience including: HPLC (SEC, IEX, RP), mass spectrometry (intact mass and peptide mapping), and capillary electrophoresis.  

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 0002-AM


DIRECTOR, QUALITY ASSURANCE

Aspyrian Therapeutics is seeking a Director of Quality Assurance, who will be a key member of the Technical Operations team with responsibility for establishing and administering all Quality functions related to cGMP operations at Aspyrian and Aspyrian’s Contract Manufacturing Organizations (CMOs). The Director will provide quality oversight and support of Aspyrian’s manufacturing, testing and product distribution functions (internal and external). The position requires domestic and international travel primarily to CMO locations to conduct audits, serve as person-in-plant for critical operations or as manufacturing designee, and to ensure compliance with cGMPs. The candidate must have a BA, MS or PhD with at least 10 years experience in a quality assurance or related role. Specific experience in biologics-based products required, and experience with antibody-drug conjugates or devices desirable. 

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 016-MGG

 

 


RESEARCH AND DEVELOPMENT PROJECT MANAGER

Aspyrian Therapeutics is seeking a Research and Development Project Manager, who will be responsible for coordinating the planning and execution of the pre-clinical and clinical activities within Aspyrian and with contract research organizations.  The project manager is expected to coordinate meetings, follow-up with meeting minutes and actions, identify gaps, track execution, forecast potential delays, integrate budgets, and find actionable solutions to challenges. The project manager will also be responsible for reviewing statements of work, master service agreements, and quality agreements. The candidate must have a BA or MS, PhD preferred, with at least 3 years experience in research and development industry and two years of experience with managing projects in industry setting.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0001ES