at Otsuka America Pharmaceutical Inc. in Topeka, Kansas, United States
Job Description
Job Description
This 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.
Qualifications
Required
+ Bachelor’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 materials
+ Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders
+ Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards
+ Experience with MS Office, especially MS Excel
+ Experience in data review
+ Must exhibit excellent oral and written communication skills
Preferred
+ Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment
+ Possess effective project management skills
+ Sound judgement, decision-making skills, negotiation skills, and good organizational skills
+ Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products
+ Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry
+ Hands on experience in method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience
+ Proficiency 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 zones
+ Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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.
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
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