Athenex, Inc.

Athenex, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of various therapies for the treatment of cancer and related conditions in North America and Asia. It operates in three segments: Oncology Innovation Platform, Global Supply Chain Platform, and Commercial Platform. The company's Orascovery product candidates include Oraxol, an oral dosage form, which is in Phase III trial for metastatic breast cancer, as well as various clinical studies in advanced malignances and gastric cancer; and Oratecan, an oral dosage form of irinotecan that is in a ... Phase I study for the treatment of metastatic colorectal cancer, glioblastoma, lung, ovarian, cervical, upper gastrointestinal, and pancreatic cancer. Its Orascovery product candidates also comprise Oradoxel, an oral dosage form of docetaxel, which is in Phase I clinical study for breast, lung, prostate, gastric, and head and neck cancers; Oratopo, an oral dosage form of topotecan that is Phase I clinical trial to treat lung, ovarian, and cervical cancer; and oral eribulin, an intravenous anticancer drug to treat certain patients with breast cancer and advanced liposarcoma. In addition, the company offers Src Kinase product candidates comprising KX2-391 ointments for actinic keratosis, skin cancers, and psoriasis; KX-01 oral for solid and liquid tumors; and KX2-361 for glioblastoma multiforme. Further, it is developing dual absorption enhancers to inhibit the P-gp transporter and the cytochrome P450 enzymes within the gastrointestinal tract; T Cell Receptor Engineered T Cell, a cell-based immunotherapy; and Pegtomarginase, an arginine deprivation therapy product. The company was formerly known as Kinex Pharmaceuticals LLC and changed its name to Athenex, Inc. in August 2015. Athenex, Inc. was founded in 2003 and is headquartered in Buffalo, New York. More

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Headquartered in Buffalo, NY
Total Employees 500 - 1,000
Company Earnings $50M - $200M
Industry Biotechnology

Popular Jobs at  Athenex, Inc.

POSITION OBJECTIVE:. As part of our global accounting team Accounting Systems Analyst assist with managing access for the ERP system and all other systems that directly impact the finance function. Responsibilities will also include data mining and extraction, report building, and system maintenance. The Accounting Systems Analyst will assist in the IT portion of the financial statement and internal control audits as directed by the Manager of Accounting Systems. The Accounting Systems Analyst will assist with implementation projects as necessary. This position will interact with all departmen... view job details

POSITION OBJECTIVE. : Provide administrative support to our Operations and Quality teams at our Athenex Pharma Solutions manufacturing facility. You will also provide general administrative support to other areas of the organization, as needed.. Essential Job Functions/Responsibilities. Operations (60%). Prepares mail or file documents, memos, monthly reports, performance evaluations and Power Point presentations. Assists in the preparation of site registrations and licensing applications to state and federal regulatory bodies as necessary in support of routine business operations. Handles mee... view job details

POSITION OBJECTIVE:. The Associate Director of Project Management, Preclinical Operations will assist in the creation of plans and execution of innovative and translational projects.. Essential Job Functions/Responsibilities. Contributing to and assuming accountability for appropriate design and implementation of a various preclinical studies to be conducted both internally and externally. Will be responsible for setting up, leading and developing these projects and providing regular reports to executive leadership on project status and progress. Manage documentation flow, timelines, budgets a... view job details

POSITION OBJECTIVE:. Promotional Material, Regulatory Affairs Leader who will direct the OPDP/Add-Prom review and approval process. This position will collaborate heavily with the commercial team preparing to launch oncology drug products.. Essential Job Functions/Responsibilities. ·      Propose and design well-informed global regulatory strategies for drug product applications and drug product promotional material. ·      Perform review of promotional material review for FDA regulated drugs. ·      Represent Regulatory Affairs on review of promotional materials and provide regulatory guidanc... view job details

POSITION OBJECTIVE:. In this role, you will be responsible for supporting the overall cell therapy GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of cell therapies and/or cultivation of human cells. Additional responsibilities include contribution to standard operating procedures (SOPs) and content of regulatory filings. You will be a technical resource for all stages of manufacturing development, logistics, and clinical operations.. Essential Job Functions/Responsibiliti... view job details

POSITION OBJECTIVE:. In this role, you will be responsible for contributing to the implementation and management of processes and appropriate quality controls related to manufacture of cell therapy materials. Additional responsibilities include, contribution to content of regulatory filings, design and management of nonclinical studies and being a technical resource for all stages of manufacturing development.. Essential Job Functions/Responsibilities. ·        Drafting, management and implementation of Standard Operating Procedures (SOPs) related to all aspects of GMP-Manufacture and clinical... view job details

As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines. Essential Job Functions/Responsibilities. Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates. Monitor clinical trial progress through a co... view job details

As a Compounding Technician, you will be responsible for ensuring the accurate production and documentation of pharmaceutical products and maintain a safe manufacturing environment. This is a first shift position. Hours are 8 AM to 5:30 PM, Monday through Friday.. Start and end times may shift due to needs of production support. Essential Job Functions/Responsibilities. Compound and package pharmaceutical products into various formats to meet company GMP & SOP requirements. Weigh, verify, and formulate raw materials according to the Manufacturing Work Order instructions. Manufacture bulk drug ... view job details

POSITION OBJECTIVE:. This position is responsible for the performance of manufacturing activities in the Controlled/Classified areas of the plant in support of 503B Compounding production. The Operator performs assigned activities including formulation, compounding and/or filling of drug products. The Operator coordinates with the area Lead to ensure production is completed in compliance with cGMPs and department SOPs. REPORTS TO:. Senior Manufacturing Manager. MANAGES:. Has no direct reports. HOURS/SHIFT:. Summer months: Tuesday through Friday, 12 PM to 10:30 PM. Non-summer months: Monday thr... view job details

POSITION OBJECTIVE:. Prepare Word and PDF documents in electronic format for submission to global health authorities, and to support regulatory affairs in document management.. Essential Job Functions/Responsibilities. Prepare Word and PDF documents in electronic format following in-house and international standards. Support regulatory affairs team with publishing on all paper and electronic submissions. Coordinate documents and metadata for regulatory submissions. Assist in accessioning, archiving and retrieval of documents. Collaborate with regulatory affairs team on developing best practice... view job details