Associate Director, Drug Product & Process De at Otsuka Pharmaceutical Co., Ltd. in undefined

The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for late‑stage drug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), and post‑approval lifecycle management (LCM). This role will serve as a key CMC contributor to cross‑functional program teams, ensuring robust, scalable, and regulatory‑compliant drug product processes from Phase 2/3 through commercialization and beyond.

Key Responsibilities

Drug Product & Process Development

Lead late‑stage drug product development activities (Phase 2/3 through commercial launch), including formulation optimization, process validation readiness, and robustness studies.

Provide technical oversight for drug product manufacturing processes, including scale‑up, tech transfer, PPQ, and commercial manufacturing support.

Ensure development strategies align with Quality by Design (QbD) principles, with clearly defined CMAs, CPPs, and control strategies.

Author and review technical development plans, process descriptions, development reports, and validation summaries.

Regulatory Filings & Health Authority Interactions

Serve as a CMC drug product lead for NDA (and/or MAA) filings, including preparation and review of Modules 2.3 and 3 sections related to drug product and manufacturing processes.

Support Health Authority interactions (FDA, EMA, etc.), including information requests, deficiency responses, and commitment fulfillment.

Ensure drug product development content is compliant with current regulatory expectations and global guidelines (e.g., ICH Q8–Q12).

Lifecycle Management (LCM)

Lead and support post‑approval LCM activities, including formulation changes, site transfers, process improvements, specification updates, and alternate sourcing.

Assess change impact and support regulatory submissions (PAS, CBE‑30, annual reports, variations).

Drive continuous improvement initiatives to enhance process robustness, manufacturability, and supply reliability.

Cross‑Functional Leadership

Act as a technical representative on cross‑functional program teams (Regulatory, Quality, Manufacturing, Supply Chain, Clinical, and Commercial).

Provide technical direction to CMOs/CDMOs, ensuring alignment with development strategy, timelines, and quality standards.

Mentor and guide junior scientists and engineers; contribute to building organizational CMC capabilities.

Qualifications

Education

PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+ years of relevant industry experience
OR

MS with 8+ years / BS with 10+ years of progressive experience in drug product/process development

Required Experience & Skills

Demonstrated experience in late‑stage drug product development (Phase 3 to commercial)

Direct involvement in NDA (or equivalent) CMC submissions, including authorship and regulatory agency interactions

Proven expertise in drug product manufacturing processes, scale‑up, tech transfer, and validation

Strong understanding of CMC regulatory requirements and global regulatory frameworks

Hands‑on experience with LCM strategies and post‑approval changes

Excellent technical writing, communication, and cross‑functional collaboration skills

Preferred Qualifications

Experience working with external manufacturing partners (CDMOs)

Experience with aseptic, solid oral, or other relevant dosage forms (tailor as needed)

Familiarity with commercial manufacturing and supply support

Prior people leadership or matrix leadership experience

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 $169,222.00 - Maximum $253,000.00, 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 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.

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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.

Learn more about this Employer on their Career Site

Associate Director, Drug Product & Process Development (Small Molecules)