LabConnect · 4 hours ago
Senior Bioanalytical Project Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expLabConnect improves lives by partnering with pharmaceutical and biotech companies to accelerate the development of new medicines. The Senior Bioanalytical Project Manager will consult and provide technical expertise across a range of bioanalytical activities, overseeing outsourced bioanalysis for clinical and pre-clinical drug development.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Oversight and management of method development, validation and sample analysis studies at contracted CROs
Provide technical input in the application and operation of quantitative bioanalytical techniques
Provide technical and regulatory expertise on bioanalytical strategies during client meetings and ensure regular updates on progress of outsourced activities to customers
Interact effectively with client’s stakeholders. This will include but not be limited to outsourcing experts, data managers, pharmacokinetic and pharmacology experts, procurement and/or bioanalytical sample managers
Source, select and engage with appropriate bioanalytical CROs for customer outsourced activities
Review bioanalytical data generated by CROs
Review draft validation and bioanalytical analysis plans, reports and study documents
Ensure effective communication and management strategies with contracted CROs
Monitor CROs activity and KPIs as required by customers
Oversight of biosample operations, support to central lab set up, kit provision to sites and sample lifecycle
Contribute to the development of A4P and LabConnect products and services
Qualification
Required
Degree/ master's level equivalent in a (bio)chemistry or similar discipline with a minimum of 10 years relevant experience in regulated bioanalysis
Extensive knowledge of PK / PD analysis within regulated environments (GLP / GCP)
Comprehensive knowledge of LC-MS/MS analysis
Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies
Experience in the pharma and/or CRO industry supporting regulated bioanalysis
Knowledge of the latest regulatory standards required for GXP studies, including international guidance published by regulatory agencies
Knowledge in design and operational execution of clinical and pre-clinical studies
Significant understanding of the research activities within a drug development organisation
Preferred
Experience in the analysis of large molecules by LC-MS/MS
Knowledge of EU IVDR / FDA regulations
Previous experience managing contract research organisations
Experience of input to regulatory submissions
Benefits
Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
Health Benefits beginning on date of hire
PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
Short and Long-Term Disability, Life Insurance, and AD&D
Company
LabConnect
LabConnect provides global central laboratory services
501-1000 employees
H1B Sponsorship
LabConnect 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$28.5MKey Investors
ABS Capital Partners
2017-06-13Series A· $24.5M
2016-03-02Series Unknown· $4M
Leadership Team
Wesley Wheeler
CEO & Director
Recent News
Precedence Research
2025-11-27
EIN Presswire
2025-11-18
2025-10-20
Company data provided by crunchbase