Sr. Scientist, Bioanalytical CRO Management, DMPK (Orexin Programs)

Reposted 14 Days Ago
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Boston, MA
In-Office
Mid level
Healthtech • Pharmaceutical
The Role
The Senior Scientist manages CROs for bioanalytical methods related to small molecule drugs, ensuring compliance and data integrity in studies.
Summary Generated by Built In

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.


Position Summary: 

The Senior Scientist in Bioanalytical CRO Management, DMPK, partners with CROs to support the development (qualification), validation, and application of bioanalytical methods for quantifying small molecule drugs and metabolites in biological matrices. This role supports both preclinical and clinical studies and requires a strong foundation in analytical chemistry, hands-on experience with mass spectrometry and related instrumentation.  The role requires a proven ability to manage CROs to ensure that bioanalytical method development and sample analyses are executed efficiently, with a quality mindset aligned with regulatory compliance. 

Key Responsibilities: 

  • Collaborate with and manage CROs for method transfer, qualification/validation, sample analysis, and data review; ensure data integrity and timely delivery
  • Review statements of work (SOWs) to ensure alignment with project objectives
  • Analyze and interpret bioanalytical data, ensuring accuracy and consistency and review study plans, method development summaries, validation reports, and regulatory documents (e.g., INDs, NDAs)
  • Coordinate compound shipments in collaboration with CMC teams
  • Track study deliverables and communicate progress to cross-functional teams and management
  • Ensure compliance with GLP and other applicable regulatory guidelines.
  • Write standard operating procedures (SOPs) and document key team decisions.
  • Represent the DMPK function in project team meetings; present results and contribute to data-driven decision-making.
  • ~10% travel to monitor CRO as needed 

Education and Qualifications: 

  • Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
  • Minimum of 4 years of industry experience in a biotech or pharmaceutical setting
  • Proven experience managing CROs and overseeing external assay transfers required
  • Strong analytical and problem-solving skills, with emphasis on assay sensitivity, selectivity, and reproducibility
  • Hands-on experience with quantitative LC-MS/MS method development and validation for small molecule drug development
  • Proficiency with LC-MS/MS instrumentation (e.g., Sciex, Waters, Thermo) and associated software (e.g., Analyst, MassLynx, Xcalibur)
  • Prior experience supporting IND-enabling studies and clinical stage development programs
  • Familiarity with regulatory bioanalytical guidelines (e.g., FDA, EMA, ICH M10) and GLP/GCP environments
  • Demonstrated ability to work cross functionally and communicate scientific findings clearly and effectively

POSITION: Full-Time, Exempt

Work Location: This is a fully remote position open to candidates based in either the United States or the United Kingdom, with infrequent travel (less than 10%) to our headquarters in Boston, MA.

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

Top Skills

Analyst
Lc-Ms/Ms
Masslynx
Sciex
Thermo
Waters
Xcalibur
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The Company
Altrincham
83 Employees
Year Founded: 2023

What We Do

Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a Research & Development innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications in rare diseases and immuno-oncology. We are led by a management team with extensive R&D experience, providing direct guidance to our program teams to rapidly advance our candidates from research through all stages of development. We are headquartered in Boston, Massachusetts

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