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Sr Scientist/ Associate Principal Scientist, LCMS Platforms

CRYSTAL PHARMATECH INC

Pleasanton, CA

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JOB DETAILS
SALARY
$120,000–$165,000 Per Year
SKILLS
Analysis Skills, Assays, Biology, Biomarkers, Biotech and Pharmaceutical, Chemistry, Communication Skills, Contract Research Organization (CRO), Customer Relations, Customer Satisfaction, Dental Insurance, Documentation, Documentation Plan, Environmental Health, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), Health Insurance, Identify Issues, Immunology, Laboratory Information Management System (LIMS), Learning Content Management Systems (LCMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mentoring, People Management, Pharmacology, Policy Development, Polymerase Chain Reaction (PCR), Pre-Clinical, Procedure Development, Quality Management, Regulations, Safety/Work Safety, Small Molecules, Software Administration, Standard Operating Procedures (SOP), Technical Leadership, Time Management, Validation Plan, Vision Plan, Writing Skills
LOCATION
Pleasanton, CA
POSTED
30+ days ago
Benefits:
  • 401(k)
  • 401(k) matching
  • Bonus based on performance
  • Dental insurance
  • Free food & snacks
  • Health insurance
  • Paid time off
  • Parental leave
  • Vision insurance

Position Summary: 


Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker.  Our clients include multinational pharmaceutical companies and biotech companies.


 The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, and biomarkers.  The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects.  The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.

Key Responsibilities: 


  • Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot LCMS-based bioanalytical methods for the quantification of small molecule (and its metabolites) and biologics (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) in support of PK, and Biomarker measurement
  • Conduct or oversee GLP/GCLP sample analysis and data reporting.  
  • Present and interpret data internally and/or externally as needed.
  • Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data.  Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
  • Serve as Subject Matter Expert (SME) for LCMS platform 
  • Ensure GLP/GCLP compliance, including accurate documentation and adherence to established procedures 
  • Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
  •  Provide technical leadership for LC-MS as a Subject Matter Expert, and mentor junior scientists. 
  • Assist in improving policies, procedures, work instructions and SOPs 
  • Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
  • Perform other related duties as assigned
Qualifications & Educational Requirements: 


  • Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(Ph.D.), 9+(Master’s) or 12+(Bachelor’s) years of CRO/Pharma/Biotech experience. 
  • Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
  • Experienced with GLP/GCLP LCMS method development and validation for PK and/or biomarker analysis.
  • Functional experience utilizing LIMS and QMS systems for GLP/GCLP bioanalysis 
  • Established record of independent achievement of objectives and timelines while maintaining high work quality.
  • Effective in team environments co-workers, managers, and clients 
  • Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
  • Effective writing and communication skills are required. 
  • Experience in large molecule LCMS analysis (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) preferred.
  • Familiarity with additional bioanalytical platforms (e.g. LBA, PCR, Flow Cytometry) preferred. 
  • Supervisory experience in both project and talent (people) management is preferred. 

Pay Transparency Statement
Title and compensation will be based on experience ( Senior Scientist / Associate Principal Scientist). 
At CP, your base pay is only part of your overall total compensation package. At the time of this posting, this role typically pays an annual base salary between $120,000 and $165,000 per year. The range displayed reflects the minimum and maximum target for new hires. Actual pay may be more or less than the posted range. Factors that influence pay include the individual's skills, qualifications, education, experience, and the position level and location.

«  As part of our recruitment process, we may use technology-assisted tools to support application review and improve efficiency. All hiring decisions are made by our team.


«  Crystal Bio Solutions is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, or any other protected status in accordance with applicable laws.
 

About the Company

C

CRYSTAL PHARMATECH INC

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