Top 1637 Assay Development Scientist Jobs

Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)
Vertex Pharmaceuticals —Boston, MA
- $138,400 - $207,600 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
- Loan repayment program
- Dental insurance
Scientist, Assay Development (Onsite)
Merck —West Point, PA
- $87,300 - $137,400 a year
- Full-time
- Bachelor of Science
- Writing skills
- Mid-level
- Paid holidays
- Health insurance
1d
Research Scientist, Life Sciences (Experimental Biology)
Anthropic —San Francisco, CA
- $300,000 - $320,000 a year
- Hybrid work
- Office
- Bachelor's degree
- Doctor of Philosophy
- Parental leave
- Flexible schedule
9d
Computational and/or Experimental Hybrid Scientist – Foster City, CA (SF Bay Area)
Illumina —San Francisco Bay Area, CA
- $113,300 - $244,000 a year
- Full-time
- Background check
- 3 years
- Master's degree
- Dental insurance
- Paid time off
Senior Staff Scientist, Assay Development (Verification & Validation)
Foresite Labs (Stealth Co) —San Diego, CA
- $175,000 - $190,000 a year
- Full-time
- Hybrid work
- Management
- Bachelor of Science
- Bachelor's degree
1d
Biological Safety Research Scientist
Anthropic —San Francisco, CA
- $300,000 - $405,000 a year
- Hybrid work
- Office
- Analysis skills
- Bachelor's degree
- Parental leave
- Flexible schedule
Method Development Scientist
Abbott Laboratories —Santa Rosa, CA
- $90,000 - $180,000 a year
- Full-time
- Bachelor's degree
- Doctor of Philosophy
- Senior level
- Health insurance
- Tuition reimbursement
9d
Scientist, Bioinformatics
Bruker —Remote
- $86,500 - $153,500 a year
- Full-time
- Remote
- No experience needed
- Databases
- Analysis skills
- Employee stock purchase plan
- Disability insurance
Senior Associate Scientist - Assay Development
Regeneron —Tarrytown, NY
- $80,300 - $131,100 a year
- Mid-level
- 3 years
- Master's degree
- Health insurance
- Dental insurance
Senior Scientist- iPSC
Trailhead Biosystems Inc. —Beachwood, OH
- $100,000 - $120,000 a year
- Full-time
- 5 years
- Analysis skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
Genetics Engineer
Confidential Posting —San Francisco, CA
- $110,000 - $150,000 a year
- Full-time
- Mid-level
- 3 years
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
Lab Technologist, QA/QC
Nittobo America Inc. —Portland, ME
- $24 - $26 an hour
- Full-time
- Word processing
- Laboratory experience
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
12d
Scientist II - ADA/PK
BioAgilytix —Durham, NC
- Full-time
- Mid-level
- Master's degree
- Bachelor's degree
- Health savings account
- Paid holidays
Quick Apply
9d
Senior Quality Control Chemist
Next X Labs —Jupiter, FL
- $60,000 - $75,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- In-person
- Health insurance
- 401(k)
Quick Apply
3d
Scientist I - ADA/PK
BioAgilytix —Durham, NC
- Full-time
- Management
- Master's degree
- Supervising experience
- Health savings account
- Paid holidays
Quick Apply
11d
Scientist I - LC/MS (Bioanalytical)
BioAgilytix —San Diego, CA
- $88,000 - $99,000 a year
- Full-time
- Customer service
- Writing skills
- Mid-level
- Health savings account
- Paid holidays
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Postdoctoral Research Fellow - McWilliams School of Biomedical Informatics
UTHealth Houston —Houston, TX
- Analysis skills
- University
- Doctor of Philosophy
- Health insurance
- Employee discount
Senior Director, Analytical Development
Rocket Pharmaceuticals —Cranbury, NJ
- $220,000 - $330,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Health insurance
Scientist I - Chemistry - 3rd Shift
Alcami Corporation —Charleston, SC
- Full-time
- Microsoft Excel
- Mid-level
- Ability to lift 50 pounds
Research Associate, Bioscience
Biotium, Inc. Fremont, California —Fremont, CA
- $73,000 - $85,000 a year
- Full-time
- Bachelor of Science
- Laboratory experience
- Research
- Relocation assistance
- Health insurance
Quick Apply

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Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)

Vertex Pharmaceuticals -
Boston, MA

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Job Details

Full-time
$138,400 - $207,600 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

USP standards
Protein analysis (analytical chemistry specialty)
ICH guidelines
Biochemical laboratory techniques
Chemical separation processes

Full Job Description

Job Description

General Summary:

The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, will be responsible for providing scientific and technical expertise within and across functional areas for late-stage & commercial methods and vendor management. S/He will manage the method life cycle, including method remediation, validation, transfer, troubleshooting and investigations for OOT/OOS, along with data trending analysis. Additionally, the principal scientist will partner closely with all stakeholders, and with contract testing sites establishing partnerships to ensure compliance with cGMP and Quality Management systems for the global network to deliver our medicines to patients effectively.

Key Duties and Responsibilities:

Lead analytical method remediation, validation and transfer for separation methods used for late stage and commercial Biologics programs.
Lead and support troubleshooting and investigations for in-process, release and stability testing.
Own Quality events and analytical related activities (Change Controls, Impact Assessments, Change Actions) related to analytical methods & related activities.
Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for worldwide commercialization and ongoing product lifecycle activities.
Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments.
Support regulatory submissions and responses to inquiries from health agencies for INDs and BLAs for Biologics as analytical method Subject Matter Expert (SME).
Author technical documents, such as method SOPs, method validation/transfer protocols and report, method bridging and risk assessments.
Work with CMO/CTO or external partners on work request, product characterization, and technology transfers.
Review method trending data and prepare APQRs.

Knowledge and Skills:

Demonstrated expertise in analytical method development, validation, transfer and lifecycle management for protein-based biologics products.
In-depth, hands-on experience in separation methods including chromatographic (with variety of separation and detection modes), electrophoretic (CE and IEF) separation or impurity methods for biologics is a must.
Familiarity with the GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP as applicable to analytical methods and commercial-stage CMC.
Familiar with analytical methods for biological products characterization including but not limited to peptide mapping and MS is a plus.
Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines related to potency assays for registrational filings is required.
Experience in statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required for data analysis and generating plots is desired.
Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners is a plus.
Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency.

Education and Experience:

PhD, Master’s or Bachelor's in Biochemistry, Chemical engineering, or a related discipline.
Typically requires the following, or the equivalent combination of education and experience: PhD and 5+ years, or Master's and 8+ years, or Bachelor's and 10+ years of relevant work experience.

Pay Range:

$138,400 - $207,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

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Assay Development Scientist jobs

Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)

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Research Scientist, Life Sciences (Experimental Biology)

Computational and/or Experimental Hybrid Scientist – Foster City, CA (SF Bay Area)

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Method Development Scientist

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Scientist I - ADA/PK

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