Senior Director, CMC

Neuraxpharm Group; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

An innovative firm is seeking a Director/Senior Director to lead CMC Management, overseeing project progression from proposal to completion. This pivotal role involves collaborating with technical and business teams to ensure successful project execution. The ideal candidate will have a PhD in a relevant field and extensive experience in the pharmaceutical industry. If you are a self-motivated leader with a passion for driving projects forward and a knack for problem-solving, this remote position offers a unique opportunity to make a significant impact in a dynamic environment.

Qualifications

• PhD in Biochemistry or related field required.
• 8-20 years of experience in pharma/biotech industry.

Responsibilities

• Lead CMC projects ensuring timely delivery and compliance.
• Collaborate with teams to execute CMC projects effectively.

Skills

Project Management

Biochemistry

Molecular Biology

Analytical Sciences

GMP Manufacturing

Communication Skills

Education

PhD in Biochemistry or related discipline

Job description

Requisition ID4827-Posted -Work From Home-United States

Job Title - Director/Senior Director/Executive Director, CMC Management

WuXi Biologics United States (Remote)

Summary:

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 WuXi Biologic’s services at conferences/trade shows.

Responsibilities:

• Provide technical and portfolio leadership to support IND and BLA, enabling CMC activities.
• Collaborate with CMC functional areas to ensure the successful execution of various CMC projects and the delivery of results on time and within budget.
• Provide strategic thinking and technical guidance for the project teams, in product development and manufacturing strategy
• Lead CMC projects with a good understanding of potential technical challenges and meeting the regulatory requirements and ICH’s guidelines
• Serve as the center of solution and decision maker for technical issues
• Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients
• Work with a high-performance team to ensure the best quality services, IP, and EHS compliance.
• Support corporate business development to enhance the current service offering and develop new clients

Qualifications:

• PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
• Technical experience at large pharma or biotech companies.
• Depending upon the titles, a minimum of8-20 years of relevant pharmaceutical or biotech industry experience in cell line development, CMC process development, analytical sciences, and/or GMP manufacturing
• Demonstrates good understanding of the pharmaceutical industry and large molecule drug development.
• Working knowledge and understanding of current regulations and industry trends for large molecule and Antibody-Drug Conjugate (ADC) product development, manufacture, and testing
• Biologics manufacturing experience
• Ability to effectively work across all levels, functions, sites, and companies. Excellent verbal and written communication skills in both English and Chinese
• 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.
• Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects at a time.
• Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred but not required.
• Must be a self-starter, self-motivated, and highly flexible in this homebased position with about 10%-15% travel.
• Must be organized and detail-oriented.

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

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