Associate Director, CMC Project Management

WuXi AppTec Group; Northern (KY); À distance; USD 110 000 - 160 000; Plein temps

Résumé du poste

WuXi AppTec Group seeks an A.D. Project Manager to lead pharmaceutical API, process R&D and Drug Product development projects, guiding them from proposal to completion with cross-functional teams. The role is remote within the US and requires English and Mandarin language skills.

You will interact with clients, technical teams, and business development, contribute to proposals, and support events like conferences and trade shows. Expect ~25% travel.

Qualifications

• Master's (MS) or PhD in life sciences; chemistry preferred.
• 5+ years of pharmaceutical or CRO/CMO experience, API process R&D/manufacturing or Drug Product R&D/manufacturing preferred.
• PMP certification desired and cross-functional collaboration experience.
• Strong project management, problem-solving, and interpersonal skills with cross-functional experience.
• Knowledge of pharmaceutical regulations and trends for small molecule manufacturing and testing.

Responsabilités

• Lead project initiation and planning efforts, and participate in implementation and execution of projects.
• Establish objectives, timelines, deliverables, and resource requirements.
• Monitor progress to ensure on-time, on-budget delivery and report progress to stakeholders.
• Support technical team with risk assessment tools and corrective actions.
• Act as liaison with client contacts and organize project team meetings.
• Represent the company in meetings, prepare agendas/minutes, and follow up on actions.
• Contribute to proposals and timelines for new client relationships and change orders.
• Travel ~25% and assist business development during client visits, conferences, and trade shows.

Connaissances

Project management

PMP certification

Cross-functional collaboration

Problem solving

Interpersonal skills

MS Office / MS Project

Communication skills

Bilingual English/Mandarin

Formation

Master's or PhD in life sciences

Outils

MS Office

MS Project

Description du poste

Overview

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.
• Establishes project objectives, timelines, and deliverables. Defines project tasks and resource requirements.
• Closely monitor/control project progression to ensure the 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 using 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 the 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 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

Education and Experience:

• 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.
• 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 a 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.

Independence/Accountability:

• 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).