The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Materials, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions. Job Description: This position provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements and works directly with the Company’s partners to ensure testing is compliant with Quality, Regulatory, and Company requirements, necessitating a high level of external communication and interaction as well as ability to manage multiple projects. The incumbent works on project teams to drive the growth and development the Company’s products, as well as with contract research/development/manufacturing organization (CRO/CDO/CMO) partners on study activities to meet established timelines and provide necessary scientific oversight for outsourced work on method development/re-development, qualification/validation, sample analysis, characterization, data delivery, and reporting. The base compensation range for this role is $150-160K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.” Summary of Key Responsibilities Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs. Oversees CMC method (large molecule) development, validation, qualification, and transfers at CRO/CDO/CMOs Oversees CMC stability programs at CRO/CDO/CMOs. Provides expert review, assessment, and trending of CMC analytical data from CRO/CDO/CMOs. Oversees characterization, qualification, and life-cycle management of reference materials. Serves as technical lead for CMC analytical testing. Manages CMC methods and specifications for release and stability. Efficiently communicates project tasks, deliverables, and timelines to external partners, ensuring that critical deadlines are agreed upon and met. Authors appropriate documentation in a timely manner to support regulatory filings, including but not limited to IND, IMPD, NDA/BLA, and pre- and post-approval changes. Authors, reviews, and/or approves all technical related protocols, SOPs, change controls, and reports, as needed, ensuring delivery of those reports to other Company departments (Manufacturing & Technical Operations, Clinical, Quality Assurance, Regulatory Affairs), external vendors, and/or license partners. Supports partners in all activities related to CMC analytical development. Assists in the department’s successful and efficient execution of departmental/area goals. Supports the Quality Assurance department in auditing activities of CRO/CDO/CMOs. Prepares for regulatory agency inspections, including pre-approval inspections at the Company’s facilities and key contractors’ facilities. Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and the therapeutic area(s) of the Company’s products. Required Qualifications and Skills BS, MS or PhD in Analytical Chemistry, Biochemistry, or related field. 10 years’ experience in CMC analytical in pharmaceutical testing environments. Extensive knowledge of development validation of CMC analytical methods. Extensive knowledge of CMC analytical techniques (e.g., HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry). Demonstrated expertise in troubleshooting and resolution of CMC related laboratory investigations and deviations. Knowledge of requirements and strategy for regulatory submissions related to CMC development; this includes all analytical modules for drug substance and drug product (3.2.S and 3.2.P). Demonstrated ability to analyze and transform CMC data (release and stability) into knowledge. Extensive knowledge of ICH, market specific guidance, national pharmacopoeia, and industry workgroups related to CMC analytical development. Demonstrated ability to assess and act on programs of work to meet business goals. Proficiency in Quality procedures (e.g., GMPs, including data integrity). Demonstrated consistency in applying and furthering scientific/technical concepts and techniques to resolve scientific/technical issues efficiently and effectively. Efficient time management, capable of multi-tasking and prioritization; structured and proactive work approach. Excellent interpersonal and communication (verbal and written); effective presentation skills to both internal and external audiences. Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro. Travel Requirements: Approximately 30% #LI-AS1 #Hybrid As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment. Be cautious of fraudulent communications claiming to be from Asahi Kasei. Incidents have occurred in which individuals impersonating Asahi Kasei recruiters have contacted people on LinkedIn requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of Asahi Kasei. Please also note that we never ask applicants to make any payments in the recruitment process. If you receive any suspicious messages or recruitment outreach that does not meet these criteria, please do not respond, and report the matter directly to LinkedIn. Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reach out to Asahi-WFP@ak-america.com. Please note we do not accept resumes or applications via email. Don't see an opening that matches your skills? Setup job alerts by selecting Sign In, located in the upper right of the page, to create an account.

Sr. Manager, CMC Analytical Development.

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