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This role provides strategy and technical expertise to oversee analytical activities at third party laboratories, including method validation/qualification, release testing, stability testing, and investigational testing. There is responsibility to develop, manage and monitor stability programs for commercial products, clinical trial materials, and developmental projects. There is a responsibility to provide regulatory support from early phase drug development to commercial. The candidate will also mentor and train team members, fostering their professional growth and expertise in pharmaceutical analytical testing.
Act as the primary relationship manager for third-party vendors, overseeing all aspects of vendor management, including contract negotiation, performance evaluation, and issue resolution, to ensure optimal service delivery and value for the organization.
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.
Involved in the strategic selection and evaluation process for third-party vendors, conducting market research, assessing vendor capabilities, and making informed recommendations to department leadership regarding vendor partnerships that align with organizational goals and objectives.
Lead the development and implementation of scientific strategies, ensuring alignment with regulatory requirements and industry best practices in the pharmaceutical field.
Collaborate cross-functionally with analytical team members, 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.
Represent the department in external meetings, fostering inter-company relationships and staying informed about Otsuka objectives.
Maintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with good documentation practices (GDP) and data integrity standards.
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.
Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in pharmaceutical testing and stability studies.
Provide subject matter expertise on testing-related topics during internal and external audits, inspections, and regulatory interactions.
Prepare stability reports and summaries for inclusion in INDs, NDAs, and regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
Develop and manage comprehensive budgets for various projects ensuring financial resources are effectively allocated and aligned with strategic objectives. Communicate accruals and forecast information to finance teams, providing clear and concise updates on project financial status and variances.
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
Experience in LIMS user role
Experience with investigation software (Trackwise preferred)
Good planning and coordination skills
Sound judgment, decision-making skills, negotiation skills, and good organizational skills
Possess effective project management skills
Develop and manage project budgets appropriately
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 $127,923.00 - Maximum $182,930.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, 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 Scams
At 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.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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