Senior Scientist I, Analytical Development jobs in United States
info-icon
This job has closed.
company-logo

Bayside Solutions ยท 4 weeks ago

Senior Scientist I, Analytical Development

positionSan Mateo County, CA
timeContract
remoteOnsite
seniorityMid, Senior Level
money$125K/yr - $146K/yr
date5+ years exp

Bayside Solutions is a company seeking a Senior Scientist I in Analytical Development. The role involves supporting analytical development and testing activities, serving as a technical subject matter expert, and collaborating cross-functionally to ensure project goals are met.

Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
check
Growth OpportunitiesbadNo H1Bnote

Responsibilities

Support analytical development and testing activities conducted at contract organizations (CMOs/CROs), including method development, method qualification/validation, and release/stability testing
Serve as a technical subject matter expert (SME) for analytical methods, ensuring that outsourced activities meet quality standards and project timelines
Review and interpret data from method validations, release testing, and characterization studies for drug substance (DS) and drug product (DP)
Prepare, review, and/or approve protocols, reports, and regulatory submission documents (IND, NDA/MAA, IMPD)
Collaborate cross-functionally with Quality, Regulatory, and external partners to ensure analytical alignment with project goals and regulatory expectations

Qualification

HPLCLC-MSMethod validationRegulatory submission documentsAnalytical developmentICH guidelinesData interpretationScientific documentationProblem-solvingCross-functional collaboration

Required

PhD in Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 5 years of relevant industry experience; or MS with 8+ years of experience in analytical development
Proficiency in analytical techniques such as HPLC/UPLC, LC-MS, XRPD, dissolution testing, DSC, DVS, and compendial methods (e.g., USP/EP)
Understanding of ICH guidelines (e.g., Q2, Q6A, Q3A, B, C, D, M7), FDA/EMA regulatory expectations, and phase-appropriate analytical development

Preferred

Strong data interpretation and problem-solving skills
Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into clear documentation

Company

Bayside Solutions

twittertwittertwitter
company-logo
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
dateFounded in 2001
location
San Ramon, California, USA
people-size51-200 employees
web-link
https://baysidesolutions.com/

Funding

Current Stage
Growth Stage

Leadership Team

B
Bob Klotz
Founder
linkedin
Company data provided by crunchbase