9408 Engineer, QA Validation
Summary:This is a temporary position supporting QA oversight of equipment, facilities, utilities qualification, and the associated systems lifecycle management activities for biologics with extensive focus on data integrity.This role offers a diverse breadth of accountability spanning all manufacturing equipment/processes, the embedded process automation systems, and analytical equipment.This individual will work […]
2757 Contracts Associate
Summary:This role will support The Company’s Legal Department and business partners by drafting, negotiating and tracking a high volume of contracts. Duties include:Researching prior contracting relationship with contracting parties.Drafting, primarily from templates, multiple contract types including Non-Disclosure Agreements, Master Service Agreements, Amendments, Scopes of Work, and Change Orders, using ARIBA […]
3541 Senior Regulatory Medical Writer
Summary:Seeking candidates who are regulatory medical writers (not Medical Communication).The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. Responsibilities:Drafts […]
6816 Supplier Operations Analyst
Role Scope:The Supplier Operations Analyst at the company is responsible for managing supplier onboarding processes and enhancing supplier relationships within the Global Procurement Operations team.This role involves troubleshooting supplier issues, developing training programs, streamlining supplier interactions and data within the Ariba/SAP system and ensuring a seamless onboarding experience for suppliers.The […]
8511 Director, Business Development
Description:The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals. Scope:Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving the Company’s products to ensure accuracy of ICSR MedDRA […]
1355 Category Manager
Duties:We are seeking a skilled and proactive Category Manager to oversee the review and negotiation of Statements of Work (SOWs) under (USD)100K.This role is critical to ensure that SOW terms align with Legal’s annotated clause guidance and sourcing policies.The successful candidate will serve as a key point of contact for […]
6970 Study Specialist II
Summary:The Company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.These conditions are often inherited, difficult to diagnose, progressively […]
0545 Training Specialist II
Duties: The Company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory […]
9931 Manufacturing Associate
Duties: Manufacturing role based in manufacturing plant. Will be on the floor performing production related activities, with light amount of bench work. Requires to independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. RESPONSIBILITIESOperate large scale bioprocess equipment for the […]