Job Title: Associate Director/Director, Process Chemistry MS&T
Job Number: 23151
Location: Waltham, MA
We are seeking an Associate Director/Director, Process Chemistry MS&T, who will have responsibility for leading assigned late-stage process chemistry activities for drug substance, DS intermediates and starting materials. The scope of the role encompasses process development, scale-up, and characterization/design space mapping. The individual will work with Process Engineering during process performance qualification (PPQ), routine commercial manufacturing, technical transfer and process improvement initiatives. Operating within a virtual (100% outsourced) business model, the incumbent will have involvement in CDMO selection and oversight and will be expected to foster the development of strong and enduring business partnerships. The successful candidate will have a key role in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs.
The successful candidate will have significant experience in process chemistry directed towards commercialization of small molecules and understanding of activities associated with product registration and commercial launch. S/he will possess strong leadership, management and communication skills.
This position will report to the Sr. Director, Drug Substance MS &T and be located in the Waltham, MA office.
- Lead and manage process chemistry teams engaged in external cGMP manufacturing of drug substance, DS intermediates, and starting materials.
- Lead and manage assigned aspects of process transfers and associated site implementations to support supply chain expansion activities and post-approval continuous improvement initiatives.
- Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events.
- Work closely with internal Quality Assurance, Regulatory CMC, Supply Chain, Process Engineering and external manufacturing operations to ensure operational excellence with respect to timelines and attainment of technical, regulatory and quality objectives.
- Participate in the selection of drug substance CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish participate in the evaluation of site technical, quality and business performance.
- Develop and maintain strong relationships with CDMO business partners.
- Review technical reports and controlled GMP documents and CMC content for Module 3 sections of regulatory dossiers.
- Continuously monitor vendor relationships; identify risks and establish mitigation plans and/or best practices to proactively address supply chain risk.
- May represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.
- Provide “Person-in-plant” coverage during critical manufacturing events at CDMOs.
- A B.S./M.S. degree in chemistry with at least 8 (AD)-12(Dir) years of experience in small-molecule pharmaceutical synthetic process research, development, and commercialization.
- Track record of success in leading and managing small-molecule drug substance programs in a 100% outsourced environment.
- Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
- Competency in developing, implementing and delivering project plans (milestones, timelines, resources, etc.) to successful endpoints.
- Strong decision-making skills and ability to influence internal and external stakeholders.
- Knowledge of the drug development process and ICH requirements for NDA and MAA registration.
- Experience in working with regulatory authorities. Experience authoring Module 3 CTD content.
- Ability to work successfully in a team/matrix environment and independently, as required.
- Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
- Ability to travel (25%) to CDMO domestic and international sites.
- Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project, SciFinder, ChemDraw) and JMP (or similar statistical tools).
- Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred.
- A Ph.D. degree in organic chemistry is highly desired.