Associate Director, CMC Project Management

Role Description

The A.D. Project Manager will be responsible for managing projects within STA, WuXi’s API, and Drug Product development and manufacturing division. 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.

Please note this is a remote (work from home) position within the US and requires English and Mandarin language skills.

Responsibilities

• Lead all project initiation and planning efforts.
• Participate in the implementation and execution of a given project.
• Establish project objectives, timelines, and deliverables.
• Define project tasks and resource requirements.
• Closely monitor/control project progression to ensure completion on schedule and within budget.
• Report project progress to all key stakeholders.
• Support the technical team to investigate project challenges using necessary risk assessment tools & techniques, then implement corrective measures.
• Serve as liaison with client contacts, manage day-to-day communications, and organize project team meetings.
• Represent the company in project meetings, prepare meeting agenda and minutes, and follow up on action items.
• Evaluate and assess project results and provide recommendations for future improvements.
• Provide support to the business development team by joining customer visits, conferences, or trade shows.
• Contribute to proposals and timelines with inputs from key stakeholders for new client relationships and change orders for existing client relationships.

Qualifications

• Master's (MS) or PhD in life sciences; chemistry preferred.
• A minimum of 5 years of 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.
• Strong and effective project management, problem-solving, and interpersonal skills.
• Proven track record working cross-functionally across a wide variety of technical, business, and operational areas.
• Good understanding of the pharmaceutical industry and small molecule drug development.
• Minimum of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing.
• Working knowledge and understanding of current regulations and industry trends for small molecule, manufacturing, and testing.
• Oligonucleotide and Solid State Peptide experience 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.

Requirements

• Must be a self-starter, self-motivated, and highly flexible in this home-based position with ~25% travel.
• Must be organized and detail-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 STA 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 communication skills (verbal, written, and presentation skills).