Top 5 Methods and process analyst Jobs in Acton, Ma

Sr. Manager/Associate Director QC Scientist (Cell Based Assays-ELISA–Late Stage Development & Process Excellence)
Aura Biosciences —Brighton, MA
- $150,000 - $215,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
- Employee stock purchase plan
- Disability insurance
Sr. Manager/Associate Director QC Scientist (Analytical–Late Stage Development & Process Excellence)
Aura Biosciences —Brighton, MA
- $150,000 - $215,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
- Employee stock purchase plan
- Disability insurance
SAP Business Process Principle - Quality and Plant Maintenance (Hybrid- Acton, MA)
Insulet Corporation —Acton, MA
- $136,900 - $205,300 a year
- Full-time
- Hybrid work
- Office
- Master's degree
- Travel
- Health insurance
- Dental insurance
Corporate Finance Process Director (REMOTE)
Charles River Laboratories —Wilmington, MA
- Full-time
- Remote
- Customer service
- Writing skills
- English
- Health insurance
- Paid time off
9d
SAP Business Process Principle - Distribution (Hybrid - Acton, MA)
Insulet Corporation —Acton, MA
- $136,900 - $205,300 a year
- Full-time
- Hybrid work
- Office
- Master's degree
- Travel
- Health insurance
- Dental insurance
1d

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Sr. Manager/Associate Director QC Scientist (Cell Based Assays-ELISA–Late Stage Development & Process Excellence)

Aura Biosciences -
Brighton, MA

Apply Now

Job Details

Full-time
$150,000 - $215,000 a year

Benefits

Employee stock purchase plan
Disability insurance
Health insurance
Paid time off
401(k) matching
Life insurance

Qualifications

USP standards
Statistics
ICH guidelines
Pharmaceutical company experience
Technology transfer (scale-up process)
Pharmaceutical analysis
Quality assurance experience within pharmaceutical industry
Verification of laboratory test methods
GMP for research safety and compliance
Test validation method
Project stakeholder communication
Negotiation
Validation design
Data analysis software
Pharmaceutical manufacturing facility experience

Full Job Description

About Aura:

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Position Summary:

Aura is seeking an experienced and highly collaborative Senior QC Scientist to support late-stage product development and drive Process Excellence initiatives. This role is critical to ensuring analytical readiness for commercial manufacturing through strong partnership with Contract Development and Manufacturing Organizations (CDMOs) and cross-functional internal teams.

The ideal candidate is a seasoned analytical chemist with deep expertise in method validation, transfer, optimization, and troubleshooting in a cGMP-regulated pharmaceutical environment. This individual thrives in complex, fast-paced settings and brings both technical depth and the ability to influence and collaborate across organizations.

Key Responsibilities

Analytical Method Life Cycle Management & Validation

Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation protocols and reports.
Manage and review work performed under method validation protocols, method performance, and any required third party activities.
Provide on-site technical readiness support and serve as SME during validation campaigns.
Troubleshoot and resolve technical challenges related to method life cycle management and validation in partnership with CDMO and internal stakeholders.
Drive continuous improvement and lessons learned initiatives across Aura and vendor sites.

Technical & Quality Leadership

Monitor and trend analytical method performance in collaboration with Analytical Development (AD).
Support quality systems activities, including change controls, deviation investigations, CAPAs, OOS investigations, and method improvements.
Perform statistical analyses to support method validation, qualification studies, and critical material qualification.
Ensure system suitability and ongoing method performance monitoring.

Documentation & Regulatory Support

Author and review GMP documentation, including:
- Method transfer protocols and reports, as required
- Validation protocols and reports
- Test methods and best-practice documents
Maintain comprehensive documentation of validation and transfer activities.
Contribute technical content to global regulatory filings supporting clinical development.

Cross-Functional Collaboration & Training

Partner closely with Analytical Development, MS&T, Quality Assurance, and external testing laboratories.
Lead training for new analytical methods at external labs and support QC analysts in execution, data analysis, and technical review.
Present analytical findings and critical issues to cross-functional teams and leadership.

Technical Expertise

Subject matter expertise in analytical methods relevant to biologics and/or advanced therapeutics, including but not limited to:

qPCR
ELISA
Potency assays
Compendial methods including microbiological methods

Strong working knowledge of regulatory requirements (FDA, EU, USP, ICH) and cGMP quality systems is required.

Qualifications

B.Sc., M.Sc., or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline
Minimum of 10 years of pharmaceutical industry experience, with significant exposure to cGMP manufacturing and late-phase method validation
Demonstrated expertise in:
- Analytical method validation and lifecycle management
- Process validation support
- Technology transfer and troubleshooting
Proficiency in statistical software (e.g., JMP or equivalent)
Strong communication, negotiation, and stakeholder management skills
Ability to operate independently, prioritize dynamically, and succeed in a fast-paced environment

Salary & Benefit Information:

Salary Range: $150,000/yr - $215,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance

Apply Now

Refine Your Search

methods and process analyst jobs in acton, ma

Sr. Manager/Associate Director QC Scientist (Cell Based Assays-ELISA–Late Stage Development & Process Excellence)

Sr. Manager/Associate Director QC Scientist (Analytical–Late Stage Development & Process Excellence)

SAP Business Process Principle - Quality and Plant Maintenance (Hybrid- Acton, MA)

Corporate Finance Process Director (REMOTE)

SAP Business Process Principle - Distribution (Hybrid - Acton, MA)

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