Position Summary The Associate Director, Analytical Development (Small Molecules)will leadthestrategy, executionand portfoliolevelof analytical development activities supporting smallmolecule ...
Position Summary The Associate Director, Analytical Development (Small Molecules)will leadthestrategy, executionand portfoliolevelof analytical development activities supporting smallmolecule ...
Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...
Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...
$134K - $201K/yr
Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...
New
$134K - $201K/yr
Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...
New
Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...
Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA · On-site
$163K - $215K/yr
The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences ... Develop and lead the CMC regulatory strategy for all small molecule assets in the I&I portfolio ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA · On-site
$163K - $215K/yr
The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences ... Develop and lead the CMC regulatory strategy for all small molecule assets in the I&I portfolio ...
Senior Scientist I Analytical Development
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to ...
Senior Scientist I Analytical Development
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to ...
Extensive experience in early phase analytical development of small molecule oral solid dosage ... forms * Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
Extensive experience in early phase analytical development of small molecule oral solid dosage ... forms * Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
Extensive experience in early phase analytical development of small molecule oral solid dosage ... forms * Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
New
Extensive experience in early phase analytical development of small molecule oral solid dosage ... forms * Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
New
Scientist 3, Analytical Development
San Diego, CA · On-site
$115K - $125K/yr
Scientist 3, Analytical Development Position Summary: * Work Schedule: Monday-Friday, core hours ... Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug ...
Scientist 3, Analytical Development
San Diego, CA · On-site
$115K - $125K/yr
Scientist 3, Analytical Development Position Summary: * Work Schedule: Monday-Friday, core hours ... Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug ...
Director, Analytical Development - SMTD
Indianapolis, IN · Hybrid
$118K - $197K/yr
This role is a key leadership position within the broader Small Molecule Technical Development (SMTD) organization, reporting to the Head of Analytical Development & QC. Your leadership will be ...
Director, Analytical Development - SMTD
Indianapolis, IN · Hybrid
$118K - $197K/yr
This role is a key leadership position within the broader Small Molecule Technical Development (SMTD) organization, reporting to the Head of Analytical Development & QC. Your leadership will be ...
Director, Analytical Development - SMTD
Indianapolis, IN · On-site
$118K - $197K/yr
This role is a key leadership position within the broader Small Molecule Technical Development (SMTD) organization, reporting to the Head of Analytical Development & QC. Your leadership will be ...
Director, Analytical Development - SMTD
Indianapolis, IN · On-site
$118K - $197K/yr
This role is a key leadership position within the broader Small Molecule Technical Development (SMTD) organization, reporting to the Head of Analytical Development & QC. Your leadership will be ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA · Hybrid
$163K - $215K/yr
The Senior Director, Regulatory Affairs CMC - Small Molecules provides senior-level scientific and ... The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA · Hybrid
$163K - $215K/yr
The Senior Director, Regulatory Affairs CMC - Small Molecules provides senior-level scientific and ... The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences ...
Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry. * Proven track record of leading analytical development through all phases ...
Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry. * Proven track record of leading analytical development through all phases ...
... of oral small molecule degraders to provide a new generation of convenient, highly effective ... As the Associate Director, Analytical Development, you will contribute to CMC activities supporting ...
... of oral small molecule degraders to provide a new generation of convenient, highly effective ... As the Associate Director, Analytical Development, you will contribute to CMC activities supporting ...
Lead analytical characterization efforts for assigned programs, including ... Phase-appropriate small molecule oral solid dose drug product method development and testing ...
Lead analytical characterization efforts for assigned programs, including ... Phase-appropriate small molecule oral solid dose drug product method development and testing ...
Lead analytical characterization efforts for assigned programs, including ... Phase-appropriate small molecule oral solid dose drug product method development and testing ...
Lead analytical characterization efforts for assigned programs, including ... Phase-appropriate small molecule oral solid dose drug product method development and testing ...
... of oral small molecule degraders to provide a new generation of convenient, highly effective ... As the Associate Director, Analytical Development, you will contribute to CMC activities supporting ...
... of oral small molecule degraders to provide a new generation of convenient, highly effective ... As the Associate Director, Analytical Development, you will contribute to CMC activities supporting ...
Extensive experience in early phase analytical development of small molecule oral solid dosage ... forms * Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
Extensive experience in early phase analytical development of small molecule oral solid dosage ... forms * Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA · On-site
$163K - $215K/yr
The Senior Director, Regulatory Affairs CMC - Small Molecules provides senior-level scientific and ... The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA · On-site
$163K - $215K/yr
The Senior Director, Regulatory Affairs CMC - Small Molecules provides senior-level scientific and ... The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences ...
Scientist 3, Analytical Development
San Diego, CA · On-site
$115K - $125K/yr
Scientist 3, Analytical Development Position Summary: * Work Schedule: Monday-Friday, core hours ... Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug ...
Scientist 3, Analytical Development
San Diego, CA · On-site
$115K - $125K/yr
Scientist 3, Analytical Development Position Summary: * Work Schedule: Monday-Friday, core hours ... Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug ...
Analytical Development Small Molecule information
See salary details
$29K - $33.7K
7% of jobs
$33.7K - $38.5K
8% of jobs
$42.6K is the 25th percentile. Wages below this are outliers.
$38.5K - $43.2K
11% of jobs
$43.2K - $47.9K
14% of jobs
The median wage is $50.4K / yr.
$47.9K - $52.6K
19% of jobs
$52.6K - $57.4K
13% of jobs
$58.8K is the 75th percentile. Wages above this are outliers.
$57.4K - $62.1K
12% of jobs
$62.1K - $66.8K
8% of jobs
$66.8K - $71.5K
4% of jobs
$71.5K - $76.3K
3% of jobs
$76.3K - $81K
1% of jobs
$29K
$53.4K
$81K
How much do analytical development small molecule jobs pay per year?
What are popular job titles related to Analytical Development Small Molecule jobs?
For Analytical Development Small Molecule jobs, the most frequently searched job titles are:

Associate Director, Analytical Development (Small Molecules)
Princeton, NJ
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 8 days ago
Job description
Position Summary
The Associate Director, Analytical Development (Small Molecules)will leadthestrategy, executionand portfoliolevelof analytical development activities supportingsmallmolecule programs from early development through NDA submission, approval, and commercialization. This role is accountable for defining and defendinganalytical control strategies, ensuring regulatory success, and managing analytical risk across multiple programs.
Associate Directorowns 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
PortfolioLevel Analytical Strategy & Governance
Contribute and executeanalytical strategiesfor a portfolio of smallmolecule programs spanningearly development through NDA and commercialization.
Establish consistent,riskbasedapproaches for:
Methodlifecycle evolution
Specification setting and tightening
Stability strategy andshelf lifejustification
Providesanalyticalrecommendations and executesagreestrategies, with accountability for regulatory outcomes.
NDA Ownership & Regulatory Leadership
Own theanalytical narrative and positioningfor 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 andparticipateinanalytical interactions with FDA and global Health Authorities, including:
NDA review discussions
Type C andpreNDAmeetings
Analytical IR strategy and response alignment
Provideanalytical SMEsupportduringpreapprovalinspections (PAIs).
Analytical Risk Management & Lifecycle Planning
Supportriskbasedassessments and provide technical inputregarding:
Bridging vs.redevelopmentof analytical methods
Timing and extent of method validation
Specification flexibility prevspostapproval
Own analytical comparability andpostapprovalchange strategies.
Ensure analytical approaches supportlongtermcommercial robustness and global regulatory compliance.
CDMO & External Partner Strategy
Support withdefiningand implementinganalytical governance modelsfor CDMOs and CROs.
Set expectations forNDAdefensibleanalytical work and inspection readiness.
Lead escalation and resolution ofhighimpactanalytical issues with external partners.
Support vendor selection, capability assessments, andlongtermoutsourcing strategy in partnership with Quality and Procurement.
CrossFunctional& CMC Leadership
Act as a strategic thought partnertoRegulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.
InfluenceCMC development strategy and timelinesthrough analytical risk assessment and mitigation planning.
Represent Analytical Development in CMC governance forums and leadership discussions.
People Leadership & Capability Building
MentorSenior Managers and Managers; coach leaders rather than individual contributors.
Build and scale analytical capabilities aligned withlatestageand 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+yearsof pharmaceutical or biotech industry experience insmallmoleculeanalytical development.
Demonstrated leadership of programs fromearly development through NDA filing and approval.
Demonstratedexperience contributingtoofNDA analytical strategy and Health Authority engagement.
Experience leading analytical functions inoutsourced/CDMObaseddevelopment models.
Technical & Regulatory Expertise
Deepexpertisein:
Stabilityindicatingmethods (HPLC/UPLC, GC, dissolution)
Impurity control (ICH Q3A/B, Q3C, genotoxic impurities)
Solidstate characterization and stability (XRPD, DSC, TGA)
Strong command ofICH Q1, Q2,Q6Aand FDA expectations for NDAs.
Demonstrated ability to develop analytically robust,inspectionreadycontrol strategies.
Leadership Competencies
Strategic thinker with strongriskbaseddecisionmaking 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.
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.
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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 EEAccommodations@otsuka-us.com.
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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.
About Otsuka Pharmaceutical
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Princeton, NJ, US