The AD/Director, MS&T Chemistry will be responsible for leading the Manufacturing Science and Technology team in the development, implementation, and support of manufacturing processes for custom lipid and nucleotide production. This role will involve collaborating with cross-functional stakeholders to ensure the successful execution of technical aspects related to the production of lipids and/or nucleotides. The AD/Director will provide leadership and guidance to a team of MS&T engineers and contribute to the growth and transformation of the MS&T Chemistry group.
Here's What You'll Do:
* Lead and oversee the growth and transformation of the new MS&T Chemistry group, establishing it as a high-performing technical support team.
* Develop and execute strategies for the internalization, scale-up, and tech transfer of chemical synthesis processes, specifically in the production of lipids and nucleotides.
* Recruit and provide technical leadership, mentoring, and coaching to the MS&T Chemistry team, which includes process engineers with expertise in chemical synthesis techniques and cGMP manufacturing.
* Facilitate tech transfer activities to ensure successful implementation of processes for right-first-time cGMP manufacturing, both internally and at external manufacturing partners.
* Provide oversight and direction for technical support of cGMP manufacturing, including troubleshooting, deviation investigations, process improvements, and change controls.
* Collaborate with cross-functional teams to align MS&T activities with overall product development strategy.
* Foster strong relationships and collaboration with technology development, CMC portfolio office, supply chain, regulatory CMC, analytical development, process engineering, quality, and manufacturing.
* Lead cross-functional project teams focused on process improvement or the development of new manufacturing capabilities.
* Communicate with executive leadership to drive alignment on critical decisions, strategy, and risk mitigations.
* Influence the development of regulatory and performance qualification strategies for chemical processes. Contribute to the authoring of regulatory filings and support the review of the CMC part of regulatory submissions and Health Authority requests.
Here's What You'll Bring to the Table:
* Bachelor's, Master's, or Ph.D. degree in Chemistry, Chemical Engineering, or a relevant pharmaceutical/chemistry science field.
* Over 10 years of experience in the pharmaceutical or other chemical synthesis industry.
* Expertise in small-molecule manufacturing, with a focus on chemical synthesis techniques, preferably in the production of lipids and/or nucleotides.
* Proven track record of tech transfer, scale-up and implementation of novel manufacturing processes.
* Previous leadership experience managing MS&T, Process Development, or Technical Development groups or functions within the pharmaceutical or chemical synthesis industry.
* Demonstrated ability to recruit, mentor, and develop a technical staff.
* Knowledge of CMC strategy, ICH guidelines, and experience in regulatory support tasks (IND, BLA, RTQ, and PAI).
* Extensive knowledge of quality systems, cGMP, and industry standards throughout drug development, including the application of such standards to starting materials
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