GMP, ICH , USP

/EP, and global regulatory standards. + Oversee stability programs at CDMOs, including data review, trending, and shelf-life justification. + Support audits, inspections, and vendor qualification activities. + Support QC contributions to

IND , BLA , MAA

, and lifecycle submissions. + Author and review Module 3 ( CMC ) sections, ensuring alignment with regulatory expectations. + Support preparation of submission-ready documentation, analytical methods, specifications, validation, and comparability strategies. + Coordinate CDMO data packages to ensure audit-ready regulatory submissions. + Support health authority interactions, including responses to queries and pre-approval inspections (PAIs). + Contribute to post-approval lifecycle activities (supplements, variations, annual reports). + Partner with Analytical Development, QA, Regulatory Affairs, CMC , and Supply Chain to align QC strategy with development and commercialization goals. Qualifications & Experience + Ph.D., MS, or BS in Biochemistry, Molecular Biology, Biotechnology, or related field. + 8-10 years of experience in biologics QC, Analytical Development, or Quality. + Strong experience working in a virtual biotech/pharma model managing CDMOs and contract labs. + Proven track record supporting global regulatory filings and inspections. + Extensive experience with

IND , BLA , MAA

, and post-approval submissions ( PAS , CBE

30, variations, annual reports).

+ Demonstrated expertise in Module 3 ( CMC ) authoring and analytical control strategies. + Strong knowledge of analytical methods, validation, comparability, and stability requirements. + Ability to integrate data from multiple CDMOs into cohesive, audit-ready submission packages. + Experience responding to health authority queries and supporting pre-approval inspections. + Strong focus on data integrity, traceability, and inspection readiness. 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 of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . 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. 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