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

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive health plan

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Drug Product & Process Development (Small Molecules) to lead late-stage development activities remotely from the United States. You will drive formulation optimization, process characterization, and scalable manufacturing to support Phase 2/3 through commercialization, ensuring QbD-aligned control strategies.

You will oversee regulatory filings (NDA/MAA), health authority interactions, and post-approval lifecycle management while

Qualifications

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related with 5+ years industry experience OR MS with 8+ years / BS with 10+ years.
• Experience in late-stage drug product development (Phase 3 to commercial).
• Direct NDA/CMC submissions involvement and regulatory agency interactions.
• Hands-on with DP manufacturing processes, scale-up, and validation.
• Strong understanding of CMC regulatory requirements and global frameworks.
• Experience with LCM strategies and post-approval changes.
• Excellent writing, communication, and cross-functional collaboration.

Responsibilities

• Lead late-stage drug product development activities (Phase 2/3 through commercialization).
• Provide technical oversight for drug product manufacturing processes, scale-up, tech transfer, PPQ, and commercial support.
• Ensure development strategies align with QbD principles with CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, reports, and validation summaries.
• Support regulatory filings and Health Authority interactions (FDA, EMA).
• Lead post-approval lifecycle management activities and drive continuous improvement.
• Mentor and guide junior scientists and engineers; collaborate across functions.

Skills

Late-stage development

NDA/CMC submissions

Tech transfer

Scale-up

CMC knowledge

Regulatory interactions

Education

PhD in Pharmaceutics/related

MS in related field

BS in related field

Job description

## Associate Director, Drug Product & Process Development (Small Molecules)Applylocations: Remotetime type: Full timeposted on: Posted Todayjob requisition id: R12455The 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.