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Overview

WuXi TIDES, a leading Contract Research and Development Manufacturing Organization (CRDMO), is an integral part of the WuXi AppTec’s subsidiary WuXi STA. WuXi TIDES offers our worldwide partners efficient, flexible, and high-quality solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates (“TIDES” drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof.

With over 1,000 scientists from 9 R&D and manufacturing sites, we offer discovery compound screening and synthesis, process development and manufacturing of novel monomers, linkers and ligands, oligonucleotides, peptides and complex synthetic conjugates at any scale. Beyond chemistry, we offer formulation development, drug product manufacturing, labeling and distribution services in a variety of injectable dosage forms and filling formats including the Lipid Nanoparticle (LNP) drug delivery platform. Our comprehensive analytical method development, validation and testing platform will support your needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to support global filings for TIDES new drug applications.

Job Summary: Responsible for managing projects within WuXi-TIDES, WuXi’s API development and manufacturing division for Oligonucleotides and Peptides. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA’s services in conferences/trade shows.

Responsibilities

• Lead all project initiation and planning efforts. Participate in the implementation and execution of a given project. Establishes project objectives, timelines and deliverables. Defines project tasks and resource requirements. Closely monitor/control project progression to ensure project is completed on schedule and within budget. Reports project progress to all key stakeholders.

• Supports the technical team to investigate any project challenges by necessary risk assessment tools & techniques, then implements corrective measures.

• Serves as liaison with client contacts, manages day-to-day communications and organizes project team meetings.

• Represents company in project meetings, prepares meeting agenda and minutes, and follows up on action items.

• Evaluates and assesses project results and provides recommendations for future improvements.

• Provides support to the business development team joining customer visits, conferences or tradeshows.

• Facilitates the generation of Quotations/Proposals/Change Orders with inputs from key stakeholders for existing relationships.

Qualifications

Technical Skills / Knowledge:

• Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.

• Demonstrates good understanding of the pharmaceutical industry and drug development.

• Minimum of 5 years of relevant pharmaceutical or biotech industry experience in discovery chemistry, CMC process development and/or GMP manufacturing.

• Working knowledge and understanding of current regulations and industry trends for oligonucleotide and Solid State Peptide experience is a plus.

• Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

• Must have working knowledge of MS Office products, especially MS Project.

Independence/Accountability:

• Must be a self-starter, self-motivated, and highly flexible in this homebased position with up to 10%travel.

• Must be organized and detailed-oriented.

Problem Solving:

• Proven experience in creating and carrying out successful plans and processes to solve complex problems.

Leadership Activities:

• Work closely with team members across all CMC related business units and with the WuXi-TIDES management team to ensure coordination of all efforts and real-time communication with all stakeholders.

• Communication Skills:

• Proficiency in both English and Mandarin is required.

• Excellent communications skills (verbal, written, and presentation skills).

Customary Education and Experience:

• Masters (MS) or PhD in life sciences; chemistry preferred

• A minimum of 5 years pharmaceutical or CRO/CMO industry experience preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing.

• Prior experience in project management or managing external research collaborations, with PMP certification desired.

Anticipated base pay range: $76,000 to $130,000

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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Job ID 2024-13233