Analytical Services Contractor

Lever, Inc.; Bristol Township, Northern (Bucks County, KY); On-site; USD 90,000 - 130,000; Full time

Job summary

Abzena is seeking a highly skilled Analytical Services Contractor to support documentation and data review within analytical development. You will review notebooks, ensure GDP compliance, and support method validation, CoT generation, and GMP-related documentation for development batches.

The role requires expertise in HPLC, GC, CE-SDS, and strong familiarity with GDP and GMP standards, enabling cross-functional collaboration and timely data integrity checks.

Qualifications

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 5+ years of industry experience in analytical development or quality control within GMP-regulated biopharmaceutical/pharmaceutical environments.
• Strong knowledge of separation-based analytical techniques (HPLC, GC, CE-SDS).
• Experience reviewing notebooks, technical reports, and GMP documents.

Responsibilities

• Review lab notebooks for GDP compliance, accuracy, and clarity of data.
• Provide technical support for separation-based assays (HPLC, GC, CE-SDS).
• Review analytical methods and ensure GMP compliance.
• Review qualification protocols/reports for methods transferred to QC for GMP manufacturing support.
• Assist in development reports and Certificates of Testing (CoT) generation for development batches.
• Ensure data and documentation meet regulatory and internal standards.

Skills

HPLC

GC

CE-SDS

GDP

GMP

Documentation

Data integrity

Cross-functional

Education

Bachelor’s degree in Chemistry or related

Tools

DMS

Job description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

We are seeking a highly skilled and detail-oriented Analytical Services Contractor to support our Analytical Services with documentation and data review activities. The ideal candidate will possess strong technical expertise in separation-based analytical techniques (e.g., HPLC, GC, CE-SDS) and have a solid understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

This individual will play a critical role in reviewing laboratory notebooks, ensuring data integrity, assessing suitability of the methods with AD management oversight, and supporting GMP-related documentation including method reviews, protocol/report reviews, and Certificates of Testing (CoT) for development batches.

• Review laboratory notebooks from Analytical Development scientists for:
• Completion and compliance with GDP
• Accuracy and clarity of data
• Suitability of analytical methods and data to support development goals
• Provide technical support for separation-based assays, including:
• HPLC such as RPLC, AEX, CEX, HIC, etc.
• GC
• CE-SDS
• Review and provide feedback on analytical methods, ensuring compliance with internal standards and GMP requirements.
• Assess and review qualification protocols and reports for analytical methods that are going to be transferred to quality control team for GMP manufacturing support and release testing.
• Support preparation and review of development reports.
• Review and assist in generation of Certificates of Testing (CoT) for development batch release and stability time points.
• Ensure data and documentation meet all regulatory and internal compliance standards.

Qualifications

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 5+ years of industry experience in analytical development or quality control within a regulated (GMP) biopharmaceutical or pharmaceutical environment.
• Strong working knowledge of separation-based analytical techniques, particularly HPLC, GC, and CE-SDS.
• Demonstrated experience in reviewing laboratory notebooks, technical reports, and GMP documents.
• Familiarity with method development and qualification principles.
• Excellent attention to detail, strong organizational skills, and the ability to manage multiple priorities.
• Effective communication and collaboration skills for cross-functional teamwork.
• Proficiency in document management systems is a plus.

Preferred Skills:

• Experience with stability testing and strong familiarity with ICH guidelines, including but not limited to: ICH Q1A–Q1E (Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products)
• Solid understanding of regulatory expectations for early-phase clinical development, including appropriate analytical data packages to support IND-enabling studies.
• Prior experience supporting IND filings is a plus.
• Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.