Job DescriptionThis role provides strategy and technical expertise to oversee analytical activities at third party laboratories, including method development/validation/qualification, stability testing, and investigational testing. In addition, there is responsibility to provide regulatory support from early phase drug development to commercial with technical aspects by developing analytical tools to gain understanding of key quality attributes in product and process for early to late phase synthetic small molecule, synthetic peptide, and/or other modalities.Collaborate cross-functionally with analytical team members, drug substance and drug product process development colleagues, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure compliance with applicable regulations and guidelines while maintaining alliance with internal timelines and corporate/project goals.Lead analytical activities such as method development, optimization and transfer for synthetic small molecules testing and characterization at CMO or contract testing labs.Provide actionable insights and recommendations to optimize project outputs for the project teams based on holistic analysis of the analytical projects including logistics, budgeting, method development through release testing and reporting. Monitor progress, identify potential risks, implement appropriate mitigation strategies, and ensure alignment with the strategic objectives.Lead the development and implementation of scientific strategies, ensuring alignment with regulatory requirements and industry best practices in the pharmaceutical field.Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity, and structure elucidation using mass spectrometry.Manage pharmaceutical stability studies, including protocols and timelines, for investigational new drug (IND) and new drug application (NDA) activities, ensuring compliance with regulatory guidelines and industry standards.Author technical reports and Chemistry, Manufacturing, and Controls (CMC) sections in regulatory documents.Mentor and train team members, fostering their professional growth and expertise in pharmaceutical analytical testing.QualificationsRequiredBachelor’s or master’s degree in analytical science, chemistry or related science + 10 years work experience or a Ph.D in analytical science, chemistry or related science + 5 years work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materialsStrong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholdersKnowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standardsExperience with MS Office, especially MS ExcelExperience in data reviewMust exhibit excellent oral and written communication skillsPreferredAbility to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environmentPossess effective project management skillsSound judgement, decision-making skills, negotiation skills, and good organizational skillsExperience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and productsStrong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistryHands on experience in method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experienceProficiency in a broad spectrum of structure elucidation and physiochemical techniques including MS, UV, NMR, FTIR, etc.Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.Ability to work effectively in cross-functional teams, and across various geographic locations in different time zonesExcellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documentsThis 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.CompetenciesAccountability 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.Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.Application Deadline: This will be posted for a minimum of 5 business days.Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.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 ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
