Job title: Director, Small Molecule Chemical Process Development
Company: Mersana Therapeutics, Inc.
Job description: nnIn this role you will have the opportunity to lead, build and influence the small molecule process development function which is part of the broader CMC Drug Substance team focused on development of the scaffolds, linkers and payloads (small molecules) used for Mersana’s proprietary Antibody Drug Conjugates (ADC’s). You will develop a team of internal process chemists and utilize external Contract Manufacturing and Developing Organizations (CDMO’s) to identify and deliver phase appropriate chemical processes for complex small molecules and macromolecules supporting the rapid advancement of clinical ADC’s. You will have the ability to build on current success and shape the function to achieve optimum success to meet future needs for a growing company. You will form close partnerships within the Drug Substance team which includes Bioconjugation, Process Engineering and Chemistry Outsourcing and rapid Clinical Supply and Supply Chain development and you will share in the building of a complementary and collaborative Drug Substance function that expertly delivers to our internal and external stakeholders and drives success. You will also build partnerships with the other CMC functions (CMC Biologics, Formulations and Drug Product, Analytical Development, Quality Assurance and Control, CMC Regulatory, Supply Chain) to support a highly integrated and collaborative CMC function. This role will have a great impact to Mersana at this exciting stage of the company’s development as you will be able to provide your hands-on technical development experience toward building a disciplined small molecule function in terms of systems, processes and technical innovation for both early stage and late stage development candidates. To be successful in this position, you should have a proven track record in leading a small molecule process development function with phase appropriate experience (early development candidates through validation) and with broad exposure to cross-functional problem solving for the many technical and operational challenges encountered during CMC development. This position reports to the Executive Director, Drug Substance CMC and the position will have direct reports and budget accountability.nn nnHow do you know if you’re the right fit?nn nnIf you are a highly self-motivated, driven individual who enjoys the challenges and opportunities available in a growing and transforming organization, this will be an opportunity for you to apply yourself, learn and deliver. You’ll thrive in an environment where you are involved in both the strategy (the bigger picture) and in the hands-on execution, and value proactive collaboration and teamwork to be successful. Additionally, you must be a subject matter expert in a Technical Process Development focused role as well as contribute to the overall CMC strategy including Analytical, Formulations, QA/QC, CMC Biologics, Regulatory, Engineering and Bioconjugation..nn nnYour experience will span the range of the following responsibilities: nn nnUtilizing external and internal resources to develop safe, cost efficient, scalable chemical processes and deliver well understood, well characterized, well documented and well controlled, fit for purpose scaffolds, linkers and highly potent payload moleculesUnderstanding and influencing the development of analytical methods and specifications needed to support process research and development of small molecules.Thinking ‘out of the box’ especially since most of the scaffolds and linkers are complex, water soluble molecules and highly potent payloads that often require unique handling and purification techniques.Understanding and influencing the CMC regulatory environment to provide a phase appropriate strategy supporting process development along with the authorship of IND’s and the small molecule Drug Substance section of an ADC BLA. Interaction with regulatory agencies, as needed, to act as a technical subject matter expert regarding small molecule development as it pertains to Antibody Drug Conjugates.Selecting and working closely with external CMO’s to help set technical expectations and deliver GMP compliant process developmentAdministrative responsibilities for budget related to small molecule development and managing projects according to Master Service Agreements, Work Orders, etc.Forming collaborative partnerships with the other CMC functions and appreciating ‘customer needs’ since the small molecule function is only a piece of the broader ADC platform.Work across all departments to meet technical objectives.Building a CMC function that has the necessary technical competencies and proper systems to assure exceptional process development.Experience with transitioning early phase projects to late phase development, including validation, is a strong positive.Participate in developing CMC development strategyWorking closely with the Sr. CMC team to support the overall CMC strategynn nnThe other stuffnn nnThis is typically a role best suited for Ph.D. level candidates who have managed direct reports as well as CMO’s and have been responsible for a process development function within a pharmaceutical or biopharmaceutical company The role is best suited for a candidate who has transitioned small molecules from early phase process development through to late stage (validation) and commercial. . You will need to travel occasionally to meet with our CMO’s who conduct the bulk of our process development and GMP manufacturing activities. You’ll demonstrate excellent verbal, written and presentation communication skills as well as organizational skills as you manage significant amounts of information and data working cross-functionally and build ‘best practice’ systems in a technically complex Antibody Drug Conjugate focused environment.nn
Location: Cambridge, IL
Job date: Fri, 16 Oct 2020 07:40:20 GMT