Associate Director, Analytical Development (Small Molecules)

Posted 6 Days Ago
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Princeton, NJ, USA
In-Office
169K-253K Annually
Expert/Leader
Internet of Things • Pharmaceutical
The Role
Leads analytical development strategy for small-molecule pharmaceutical programs from early development through NDA approval and commercialization. Owns analytical control strategies, regulatory positioning, risk management, method lifecycle planning, stability and impurity control, and Health Authority interactions. Oversees CDMO and CRO analytical governance, supports inspections, influences CMC strategy, and mentors analytical leaders while building scalable late-stage and commercial capabilities.
Summary Generated by Built In

Position Summary 

The Associate Director, Analytical Development (Small Molecules) will lead the strategy, execution and portfolio level of analytical development activities supporting small molecule programs from early development through NDA submission, approval, and commercialization. This role is accountable for defining and defending analytical control strategies, ensuring regulatory success, and managing analytical risk across multiple programs. 

Associate Director owns analytical strategy, risk posture, and NDA analytical positioning, serves as the primary analytical interface with Regulatory Affairs and Health Authorities, and builds scalable analytical capability across the organization. 

 

Key Responsibilities 

Portfolio Level Analytical Strategy & Governance 

  • Contribute and execute analytical strategies for a portfolio of small molecule programs spanning early development through NDA and commercialization. 

  • Establish consistent, risk based approaches for:  

  • Method lifecycle evolution 

  • Specification setting and tightening 

  • Stability strategy and shelf life justification 

  • Provides analytical recommendations and executes agree strategies, with accountability for regulatory outcomes. 

NDA Ownership & Regulatory Leadership 

  • Own the analytical narrative and positioning for NDAs, ensuring coherence across:  

  • Drug substance (3.2.S) 

  • Drug product (3.2.P) 

  • Impurities, stability, and control strategies 

  • Review, approve, and integrate analytical content authored by Senior Managers and external partners. 

  • Support and participate in analytical interactions with FDA and global Health Authorities, including:  

  • NDA review discussions 

  • Type C and preNDA meetings 

  • Analytical IR strategy and response alignment 

  • Provide analytical SME support during preapproval inspections (PAIs). 

Analytical Risk Management & Lifecycle Planning 

  • Support riskbased assessments and provide technical input regarding:  

  • Bridging vs. redevelopment of analytical methods 

  • Timing and extent of method validation 

  • Specification flexibility pre vs postapproval 

  • Own analytical comparability and postapproval change strategies. 

  • Ensure analytical approaches support longterm commercial robustness and global regulatory compliance. 

CDMO & External Partner Strategy 

  • Support with defining and implementing analytical governance models for CDMOs and CROs. 

  • Set expectations for NDAdefensible analytical work and inspection readiness. 

  • Lead escalation and resolution of highimpact analytical issues with external partners. 

  • Support vendor selection, capability assessments, and longterm outsourcing strategy in partnership with Quality and Procurement. 

CrossFunctional & CMC Leadership 

  • Act as a strategic thought partner to Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain. 

  • Influence CMC development strategy and timelines through analytical risk assessment and mitigation planning. 

  • Represent Analytical Development in CMC governance forums and leadership discussions. 

People Leadership & Capability Building 

  • Mentor Senior Managers and Managers; coach leaders rather than individual contributors. 

  • Build and scale analytical capabilities aligned with latestage and commercial needs. 

  • Own analytical resourcing strategy, succession planning, and capability development. 

 

Qualifications 

Education 

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline; or 

  • M.S. with extensive, directly relevant industry experience. 

Experience 

  • 12–15+ years of pharmaceutical or biotech industry experience in smallmolecule analytical development. 

  • Demonstrated leadership of programs from early development through NDA filing and approval. 

  • Demonstrated experience contributing to of NDA analytical strategy and Health Authority engagement. 

  • Experience leading analytical functions in outsourced/CDMObased development models. 

Technical & Regulatory Expertise 

  • Deep expertise in:  

  • Stability indicating methods (HPLC/UPLC, GC, dissolution) 

  • Impurity control (ICH Q3A/B, Q3C, genotoxic impurities) 

  • Solid state characterization and stability (XRPD, DSC, TGA) 

  • Strong command of ICH Q1, Q2, Q6A and FDA expectations for NDAs. 

  • Demonstrated ability to develop analytically robust, inspection ready control strategies. 

Leadership Competencies 

  • Strategic thinker with strong risk based decision making capability. 

  • Influential leader in matrixed organizations. 

  • Clear, authoritative communicator with strong regulatory writing and presentation skills. 

  • Proven ability to balance speed, risk, cost, and compliance. 

 

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://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.


Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591

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 [email protected]

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. 

Skills Required

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline
  • Alternatively, an M.S. degree with extensive, directly relevant industry experience
  • 12–15+ years of pharmaceutical or biotech industry experience in small-molecule analytical development
  • Leadership experience taking programs from early development through NDA filing and approval
  • Experience contributing to NDA analytical strategy and Health Authority engagement
  • Experience leading analytical functions in outsourced or CDMO-based development models
  • Deep expertise in stability-indicating methods, including HPLC/UPLC, GC, and dissolution
  • Expertise in impurity control, including ICH Q3A/B, Q3C, and genotoxic impurities
  • Expertise in solid-state characterization and stability using XRPD, DSC, and TGA
  • Strong command of ICH Q1, Q2, and Q6A and FDA NDA expectations
  • Ability to develop analytically robust, inspection-ready control strategies
  • Strong risk-based decision-making, matrix leadership, regulatory writing, presentation, and communication skills

Otsuka America Pharmaceutical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Otsuka America Pharmaceutical and has not been reviewed or approved by Otsuka America Pharmaceutical.

  • Healthcare Strength Health coverage spans medical, dental, vision, prescription services, telehealth, life insurance, and disability, with notable mental‑health access through therapy, coaching, and digital tools. Wellness resources such as fitness reimbursement, nutrition support, and caregiver assistance further reinforce overall healthcare robustness.
  • Retirement Support Retirement offerings include a strong 401(k) match alongside personalized financial counseling for tax planning, education funding, home buying, and estate planning. These features position retirement support as a differentiator within the total rewards package.
  • Leave & Time Off Breadth Time‑off policies include flexible time off, paid holidays, volunteer time off, and a company winter holiday break. The breadth of leave programs supports work–life balance across various needs.

Otsuka America Pharmaceutical Insights

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The Company
HQ: Princeton, NJ
3,516 Employees
Year Founded: 1989

What We Do

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.

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