The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the Associate Director, Chemical Development, the Senior Scientist, Chemical Development will serve as a technical subject matter expert responsible for drug substance development from development candidate nomination through commercialization. The successful candidate needs to demonstrate a proven track record of working in a virtual environment with CDMOs to deliver manufacturing processes that can be scaled to deliver drug substance for fast-paced clinical development programs. Using strategic thinking, the candidate must be able to develop and defend a process design space.
This individual will oversee drug substance process development, scale up, and manufacturing activities related to Nuvalent’s development and clinical programs. The main directive will be to ensure that drug substance supply is not rate limiting to any program’s overall development, while ensuring that the material delivered is of high quality and economically sound.
Responsibilities:
• Solve technical issues relating to external drug substance manufacturing by providing leadership within the Chemical Development group.
• Responsible for drug substance process design, optimization, scale-up, technology transfer, validation, and maintaining the lifecycle of the product.
• Ensure relevant data is captured in reports provided by external CROs/CMOs.
• Manages external CROs/CMOs, as well as vendors.
• Compare and contrast lab and manufacturing process information to provide insights.
• Ensure that the drug substance development is compliant with both relevant regulations and regulatory commitments.
• Author relevant regulatory documents.
Competencies:
• Excellent organization and multi-tasking skills.
• Exceptional interpersonal skills and experience building productive teams and cross functional relationships.
• Capable of being an independent decision maker, and comfortable with accountability.
Qualifications:
• PhD in organic chemistry or chemical engineering with a minimum of 5 years of industry experience or Bachelors / Masters and 10 years of industry experience in a chemical development role.
• Proven track record solving chemical and manufacturing challenges at all stages of development.
• Mastery of current ICH guidelines and related industry guidelines and practices.
• Management experience with CROs and CDMOs and working in an outsourced regulated environment.
• Ability to author and review relevant process development reports as well as regulatory sections.
• Previous exposure to Process Performance Qualification is desirable.
• Experience working in a drug substance manufacturing plant is highly desirable.
• Experience with implementation of QbD strategies during drug substance development and Life-cycle management.
• Up to 20% travel is expected, both domestic and international.
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
BruntWork
BruntWork
Kitchen Stories - Anyone can cook!
XPT Software Australia
