Job Description

Job Summary The Associate Director chemical development will lead process development and optimization of drug substances and will manage manufacturing activities for API, intermediate, and RSMs for assigned projects. The Associate Director chemical development will assist with the preparation and review of drug substance sections for regulatory submissions and will be responsible for the preparation and technical review of GMP documents for API, intermediate, and RSM manufacture. Job Description Responsible for chemical process development and optimization, technology transfer, scale-up, and process validation of APIs Manage API, intermediate, and RSM manufacturing activities at CDMO sites to meet clinical supply demand Direct the development activities of drug substances from early to late-stage projects in a phase-appropriate manner, which includes managing solid-state properties such as salt forms, solvates, and polymorphs, as well as process control strategies for impurities, potential mutagenic impurities (PMIs), elemental impurities, and residual solvents Responsible to develop new and improved chemical manufacturing processes with an eye to reducing COGS, improving yields and upgrading quality of the drug substance, and provide technical support for existing chemical processes at CDMO sites Draft, review, and approve GMP/scientific documents such as manufacturing batch records, protocols, and reports in compliance with cGMP and global regulatory requirements and the drug substance sections of global regulatory submissions such as INDs, IMPDs, NDAs, and MAAs. Actively contribute expertise in cross-functional R&D project teams as the subject matter expert for drug substances and be well prepared to address any questions or discussions related to APIs for assigned projects Coordinate inventory control of drug substances, starting materials, and key materials/reagents with internal and external partners to ensure project demands are met within timelines for assigned projects Demonstrate excellent interpersonal skills and effective verbal and written communication skills with cross-functional teams (pharmaceutical development, clinical development, regulatory affairs, and quality assurance) and CDMO partners to build relationships and effectively progress projects forward You must be highly organized, self-motivated, and able to juggle multiple priorities. The desired candidate will have the capacity to be productive with little supervision Perform other related duties and responsibilities as assigned Qualifications Education and background: PhD in Organic Chemistry, Chemical Engineering, or related sciences with 8 years of relevant experience, or an MS in Organic Chemistry, Chemical Engineering, or related sciences with 10 years of relevant experience Experience: Process Development: Strong process chemistry experience with demonstrated expertise in process development and optimization, technology transfer, and scale up of drug substances/APIs, and ability to solve challenging problems that arise during technology transfer, process optimization and scale up of drug substances/APIs API Manufacturing: Experience in managing manufacturing of APIs. Intermediates and RSMs at CDMO sites and implementing manufacturing technology improvements within a regulated environment Regulatory Compliance: Experience with providing technical authoring and review of CMC drug substance sections of regulatory filings and dossiers. Familiarity with cGMP (current Good Manufacturing Practices) and regulatory requirements (ICH, FDA, EMA, etc.) Travel up to 25% Skills and Competencies: Working knowledge of quality systems, validation principles, engineering design, process modeling and statistical process control fundamentals Proficient with all MS Office application skills Excellent interpersonal, and written and verbal communication skills with a demonstrated ability to establish and maintain effective relationships internally and with external manufacturing partners Strong organizational skills to handle multiple priorities and meet project timelines Attention to detail in drafting and reviewing GMP documents Ability to work strategically and independently with internal and external groups on multiple projects Flexibility to adapt to changing project needs Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; . Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. 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