Top 286 Analytical validation manager Jobs in Boston, Ma

Senior Manager, Analytical Sciences - Commercial
Praxis Precision Medicines, Inc. —Boston, MA
- $147,000 - $167,000 a year
- Email
- 7 years
- Master's degree
- Bachelor's degree
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Quality Control Manager (External Operations)
Eli Lilly —Boston, MA
- $71,250 - $161,700 a year
- Overtime
- Hybrid work
- Bachelor of Science
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
2d
SaaS Senior Engineer, Information Security, Architecture and Engineering - Technology Solutions Group
Bain & Co. —Boston, MA
- $108,250 - $130,000 a year
- Full-time
- Salesforce
- Office
- 3 years
- Wellness program
- Paid holidays
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BCG Platinion | Manager, Cybersecurity
Boston Consulting Group —Boston, MA
- $190,000 a year
- Full-time
- 6 years
- Bachelor of Science
- Urgent Care
- Profit sharing
- Paid parental leave
10d
Senior Data Engineer
Consigli Construction —Boston, MA
- $100,000 - $120,000 a year
- Full-time
- 5 years
- SQL
- Analysis skills
Quick Apply
Building Commissioning Engineer
CAI —Boston, MA
- $98,000 - $130,000 a year
- Full-time
- Hybrid work
- Construction site
- Engineering
- Mid-level
- Disability insurance
- Health insurance
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Senior Accountant
Vaco by Highspring —Danvers, MA
- $95,000 - $115,000 a year
- ERP systems
- Finance
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
7d
Quality Control Technician
North Coast Seafoods —Boston, MA
- Weekends as needed
- Customer service
- Basic math
- Mid-level
- Health insurance
- 401(k)
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Technical Solution Architect
Experis —Boston, MA
- $96.42 an hour
- Contract
- Hybrid work
- 5 years
- Office
- Product management
Quick Apply
1d
Building Commissioning Engineer
CAI —Boston, MA
- $80,000 - $130,000 a year
- Full-time
- Hybrid work
- Construction site
- Engineering
- Mid-level
- Disability insurance
- Health insurance
Quick Apply
Healthcare Compliance Operations Manager/ Senior Manager
Ionis Pharmaceuticals, Inc. —Boston, MA
- $72,800 - $129,967 a year
- Remote
- Analysis skills
- Bachelor's degree
- Travel
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14d
Senior Manager, Quality Control GMP
Cogent Biosciences —Waltham, MA
- $155,000 - $185,000 a year
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Free parking
- Paid parental leave
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7d
Compensation Operations Manager
DraftKings —Boston, MA
- $131,200 - $164,000 a year
- Full-time
- Remote
- 5 years
- Analysis skills
- Senior level
Manager of Consumer Insights
Welch's —Waltham, MA
- $120,000 - $130,000 a year
- Full-time
- Hybrid work
- Marketing
- 5 years
- Office
- Paid parental leave
- Health savings account
Quick Apply
Deposit Operations Manager
Metro Credit Union —Chelsea, MA
- $96,000 - $129,000 a year
- Hybrid work
- 7 years
- Office
- Analysis skills
- Wellness program
- AD&D insurance
Quick Apply
Manager, IT Data Integration Lead
Biogen —Cambridge, MA
- $121,000 - $162,000 a year
- Full-time
- Hybrid work
- 5 years
- HIPAA
- SQL
- Paid parental leave
- Employee stock purchase plan
Compliance Reporting Program Manager
Cohere Health —Boston, MA
- $110,000 - $125,000 a year
- Remote
- 8 years
- SQL
- Analysis skills
- Paid parental leave
- Health savings account
Quick Apply
Business Intelligence Manager
Clean Harbors —Norwell, MA
- $94,300.00 - $264,899.05 a year
- Online Application
- Office
- 3 years
- SQL
- Paid training
- Employee stock purchase plan
Project Manager, MEL
Broad Institute —Cambridge, MA
- $83,000 - $116,333 a year
- Full-time
- 3 years
- Master's degree
- Analysis skills
- Health savings account
- Paid holidays
Compliance Reporting Analyst
MFS Investment Management —Boston, MA
- $55,500 - $80,500 a year
- Full-time
- Hybrid work
- Mid-level
- Finance
- Bachelor's degree
- Commuter assistance
- Health savings account
2d

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Senior Manager, Analytical Sciences - Commercial

Praxis Precision Medicines, Inc. -
Boston, MA

Quick Apply

Job Details

$147,000 - $167,000 a year

Qualifications

Data integrity assurance
FDA submissions
Regulatory inspections
Stability testing
7 years
Investigations regulatory compliance
Defect resolution root cause analysis
Stability studies in drug product development
Team leadership
Technical documentation
Preventive action implementation
Supply chain risk management
Production deviation management
Production risk assessment
Chromatographs
Corrective and preventive actions (CAPA)
FDA 21 CFR Part 11
GMP
Technical report writing
Internal investigations
Quality improvement leadership
Master's degree
Data quality management
Data integrity and documentation
ICH guidelines
Bachelor's degree
Technology transfer (scale-up process)
Pharmaceutical analysis
Compliance documentation
Regulatory/legal compliance standards in production

Full Job Description

Location: This position may be performed remotely with travel to the Boston area as needed, and an expected 20–30% travel to CDMO sites, particularly during validation campaigns, critical investigations, and health authority inspections.

The Opportunity

The Senior Manager, Analytical Sciences – Commercial serves as the analytical lead for Praxis' commercial portfolio, ensuring commercial manufacturing testing is executed in compliance with regulatory commitments and supporting lifecycle management of approved products.

This role oversees analytical activities at CDMOs supporting small molecule drug substance and drug product manufacturing and is accountable for maintaining robust analytical methods, control strategies, data integrity, inspection readiness, and continuity of supply. The position also supports late-stage programs transitioning into commercialization to ensure a compliant and efficient transfer into commercial operations.

Primary Responsibilities

Define and execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant, robust, and fit for purpose.
Lead method transfer, validation, and lifecycle management activities, identifying opportunities for improvement and supporting post-approval changes.
Provide analytical leadership for PPQ, CPV, commercial manufacturing, and stability programs, ensuring reliable data, product quality, and regulatory compliance.
Review and approve analytical documentation, including protocols, reports, specifications, method validations, Certificates of Analysis, raw data, chromatographic integrations, and audit trails.
Oversee analytical execution at CDMOs, ensuring timely, compliant deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections.
Lead analytical investigations involving OOS/OOT results, deviations, complaints, and CAPAs, driving root cause determination and technical recommendations consistent with FDA and EU GMP expectations.
Assess analytical risks associated with manufacturing, supply chain, and process changes, ensurin gappropriate impurity controls and lifecycle management strategies are maintained.
Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities.
Serve as the analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations and informed decision-making.

Qualifications and Key Success Factors

Bachelor's degree in Chemistryor related discipline with 10+ years of relevant experience; Master's degree with 7+ years of experience may be considered.
Experience supporting commercial small molecule drug substance and/or drug product programs; analytical development experience preferred.
Strongexpertisein analytical method transfer, validation, troubleshooting, and lifecycle management within GMP environments.
Technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.
Demonstratedability to review analytical data, chromatographic integrations, and electronic audit trails in accordance with ALCOA+, 21 CFR Part 11, and EU GMP Annex 11 requirements.
Experience managing commercial analytical methods and control strategies, including evaluating and implementing method improvements.
Working knowledge of US and EU cGMP requirements and applicable ICH guidelines, including impurity and mutagenic impurity guidance.
Experience supporting regulatory submissions, post-approval changes, and health authority inspections; direct FDA or EMA inspection support experience preferred.
Proven ability to build productive partnerships with CDMOs and external service providers while driving accountability and results.
The physical and mental requirements of this role include regular use of a computer, mobile devices, and office equipment; clear communication; and occasional travel to laboratory, manufacturing, and office environments. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected].

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

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Refine Your Search

analytical validation manager jobs in boston, ma

Senior Manager, Analytical Sciences - Commercial

Quality Control Manager (External Operations)

SaaS Senior Engineer, Information Security, Architecture and Engineering - Technology Solutions Group

BCG Platinion | Manager, Cybersecurity

Senior Data Engineer

Building Commissioning Engineer

Senior Accountant

Quality Control Technician

Technical Solution Architect

Building Commissioning Engineer

Healthcare Compliance Operations Manager/ Senior Manager

Senior Manager, Quality Control GMP

Compensation Operations Manager

Manager of Consumer Insights

Deposit Operations Manager

Manager, IT Data Integration Lead

Compliance Reporting Program Manager

Business Intelligence Manager

Project Manager, MEL

Compliance Reporting Analyst

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