SIGN IN
Associate Director, Analytical Development – Small Molecule jobs in United States
cer-icon
Apply on Employer Site
company-logo

Centessa Pharmaceuticals · 1 week ago

Associate Director, Analytical Development – Small Molecule

positionUnited States
timeFull-time
remoteRemote
seniorityLead/Staff
money$180K/yr - $195K/yr
date10+ years exp
Centessa Pharmaceuticals is a new kind of pharmaceutical company focused on data-driven decision making and advancing a portfolio of high conviction programs. They are seeking an Associate Director of Analytical R&D to lead small molecule analytical activities across early to late-stage development, overseeing vendor work and ensuring compliance with regulatory guidance.
BiotechnologyLife SciencePharmaceuticalClinical Trials
check
H1B Sponsor Likelynote

Responsibilities

Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs
Work in a team environment to manage drug substance and drug product analytical development activities primarily at third-party vendors including analytical method implementation, qualification/validation, and transfer for drug substance and drug product projects
Review method validation protocols, reports, and transfer activities
Review test data for release, stability, and characterization plans for projects
Save and store documentation, generate stability result tables, file stability data and results data
Monitor stability due dates and coordinate data transfer from vendors
Review analytical documents including but not limited to protocols, reports, and procedures
Act as the CMC team analytical representative member in cross functional developmental teams
Contribute to CMC analytical aspects of regulatory filings; review and assemble information for analytical sections in regulatory submission documents (e.g. IND, IMPD, NDA, etc)
Coordinate and execute domestic and international shipments
Serve as a technical expert and aid in analytical investigations and troubleshooting
Assist with batch record review and deviation investigations

Qualification

Small molecule analytical developmentCGMPRegulatory guidance for biologicsMethod development and validationProduct characterizationComparability assessmentAnalytical method implementationMethod transferMethod validation protocolsStability studiesICH stability guidelinesCompendial methods USPCompendial methods EPHPLC/UPLCGas Chromatography (GC)Karl Fischer titration (KF)X-ray Powder Diffraction (XRPD)Residual solvents analysisElemental impurities testingMicrobial testingDissolution testingQC laboratory processesVendor management CMOsVendor management CDMOsAnalytical planningResource management

Required

PhD in Chemistry, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience
10+ years of experience in biotech/pharmaceutical industry in small molecules, working in early to late-development (pre-clinical to phase 3)
Strong analytical planning and resource management skills in a dynamic environment located across multiple geographies
In depth knowledge of assay and related substances development, forced degradation, HPLC/UPLC, GC, KF, XRPD, residual solvents, elemental impurities, microbial testing, dissolution, compendial methods
Hands-on experience in carrying out stability studies for drug substance and drug product in development and/or QC settings
Experience managing DS/DP stability, and knowledge of ICH stability guidelines
Knowledge of compendial (USP, EP, etc) requirements and standards
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
Strong organizational skills and attention to detail
Good interpersonal and communication skills to collaborate effectively with internal and external business partners
Requires a good understanding of managing groups, CMOs, CDMOs and other vendors

Benefits

Discretionary annual bonus
401(k) plan
Company-sponsored medical, dental, vision, and life insurance
Generous paid time off
Health and wellness program

Company

Centessa Pharmaceuticals

twitterlinkedincrunchbase
company-logo
Centessa Pharmaceuticals is a pharmaceutical company that focuses on drug development to address significant medical needs.
dateFounded in 2021
location
Cambridge, Massachusetts, USA
people-size51-200 employees
web-link
https://www.centessa.com

H1B Sponsorship

Centessa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
50%
Represents job field similar to this job
Engineering and Development
Management and Executive
Trends of Total Sponsorships
*2025 (1)
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$1.12B
Key Investors
Oberland CapitalGeneral Atlantic,Janus Henderson Investors,Vida Ventures
2026-03-31Acquired
2025-11-11Post Ipo Equity· $250M
2024-09-11Post Ipo Equity· $225M

Leadership Team

leader-logo
John Crowley
Chief Financial Officer
linkedin
leader-logo
Gregory Weinhoff
Chief Business Officer
linkedin

Recent News

Clinical Trials Arena
Alkermes releases nine-month data as OX2R race heats up
2026-07-14
Foresite Capital
Foresite Capital portfolio
2026-07-03
Morningstar.com
Healthcare stocks have become a haven for investors ditching tech
2026-06-26
Company data provided by crunchbase