Resolian Bioanalytics Jobs in Usa

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.

Job Description: Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development

Position Overview: The Research Associate III/ Senior Research Associate in Assay Development and Bioanalytical Development will play a critical role in the development, qualification, and validation of bioanalytical methods to support our RNA editing programs. The successful candidate will work under the guidance of an assay development scientist to develop custom assays for the analysis of samples, including AAVs, cells, and tissues. This role also involves drafting key documents such as Standard Operating Procedures (SOPs) and method development reports.

Key Responsibilities:

• Method Development, Qualification, and Validation:
• Support the development, qualification, and validation of bioanalytical methods in accordance with regulatory guidelines.
• Develop, optimize, and execute robust bioanalytical methods for the characterization, release, and stability testing of Amber's gene therapy.
• Sample Analysis:
• Support drug absorption, distribution, metabolism, and excretion studies.
• Perform analysis of AAVs, cells, and tissues to support various stages of research and development.
• Lead efforts to streamline and optimize sample storage and processing, as well as establishing and maintaining critical reagent stocks and cell banks.
• Documentation Reporting:
• Draft and review key documents such as SOPs, method development, and sample analysis reports.
• Maintain accurate and detailed records of all experiments and analyses.
• Collaboration & Communication
• Collaborate with manufacturing and preclinical teams to support pipeline needs.
• Communicate and present findings clearly to internal stakeholders.

Qualifications:

• B.A./B.S. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
• 3+ years of experience in bioanalytical and assay development in the biotechnology or pharmaceutical industry.
• Demonstrated strong proficiency in a wide range of molecular biology techniques such as molecular cloning, DNA/RNA extractions, RT-qPCR, ddPCR, and ELISA.
• Experience with cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
• Hands-on experience using laboratory automated systems (e.g., liquid handlers, extraction robotics, etc.).
• Background in RNA-based therapies is highly desirable.
• Experience writing SOPs and reports supporting IND filings (e.g. development, qualification sample analysis reports, etc.)
• Knowledge of FDA and ICH guidelines for method development, qualification, and validation.
• Prior history in compiling and analyzing data and generating reports that are routinely presented to project teams.
• Ability to work effectively in a collaborative, fast-paced environment.

Preference will be given to those who display:

• High motivation, with a strong work ethic and dedication to generating impact.
• Attention to detail, with the ability to extract deep insights from data.
• Ability to go from ideation to data in an independent fashion.
• Long-term personal vision with defined career goals.
• Team-oriented thinking.
• Demonstrated excellence in small team environments, including a “no task is too small” attitude.

If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.

Please apply directly through LinkedIn.

Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

Position: Associate Director, Clinical Quality Compliance

Location: Bedford, MA (On-site 3 days/week)

Length: 6 Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.

Job Description:

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Essential Duties and Responsibilities:

• Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.

Qualifications:

• BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

# 18352

Title: Associate Scientist, qc

Location: King of Prussia, PA

Department: Technology Development and Analytical Services

Reports To: Manager, QC Testing

*Contract position*

SK pharmteco, Cell and Gene US, is looking for a highly skilled Associate Scientist to join the Bioanalytical and Biophysical Analytical Development team. The Associate Scientist will primarily engage in analytical development, assay qualification/validation, and analytical testing for cell and gene therapy products.

Position Summary:

• Collaborate effectively with a dynamic team of scientists and multidisciplinary groups involved in the production and analytical testing of cell and gene therapy products.
• Independently perform PCR-based assays, including ddPCR, qPCR, and RT-qPCR, for applications such as genomic titer, residual DNA, and related QC release testing as assigned
• Perform laboratory tasks for assay development, qualification/validation, and sample testing of cell and gene therapy products.
• Familiarize with various assays conducted by the team and learn to execute them in GLP/GMP environments.
• Ensure accurate laboratory records are maintained.
• Draft technical reports in accordance with good documentation practices and company standard operating procedures.
• Conduct testing in GMP environments according to the company’s requirements.
• Prepare presentations and communicate technical results to internal teams.
• Complete reagent qualification and associated documentation.
• Support audits and regulatory inspections as needed.
• Assist with instrument maintenance and ensure laboratory organization.
• Strict adherence to laboratory safety protocols and compliance guidelines.
• Additional duties as assigned.

Education, Experience, & Qualification:

• Bachelor’s degree in science preferably molecular biology, immunology or related discipline.
• At least 1 year laboratory experience in analyzing PCR data or cell based assays is preferred
• Previous experience in safe handling of gene therapy product is preferred.
• Knowledge in FDA and ICH regulatory guidelines and prior work experience in GMP regulated environment is a desirable.

Key Competencies:

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.
• Strong eagerness to learn new analytical techniques and broaden knowledge and experience

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

Responsibilities

(QA Auditor I, II, III)

· Audit documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11

· Verify lab tasks are performed in accordance to Good Documentation Practices (GDP)

· Audit laboratory documents and notebooks (e.g. plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations

· Audit data files and reports

· Audit computer systems, facility operations, and other non-study regulated activities

· Assist with maintaining Master Schedule

· Identify non-compliance, deviations, and Quality events and assist with resolution

· Escalate data integrity and non-compliance issues to Management

· Follow applicable SOPs and procedural documents

· Assist with template and SOP review

· Participate in client audits as needed

· Enforce lab SOPs and requirements

· Review system audit trails

· Other tasks as assigned

(QA Auditor II and III)

· Conduct quality training as needed

· Track and present quality metrics

· Perform vender qualifications and audits

· Train and mentor lower level Auditors

· Review and evaluate procedures to improve quality and efficiency

· Participate in CAPAs and investigations as needed

· Review and author templates and SOPs

· Other tasks as assigned

Skills, Education & Qualifications

· BA/BS or higher; all experiences will be evaluated

· 1-7 years experience in GxP Environment, all experiences will be evaluated

· Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP

· Familiar with pharmaceutical or biotechnology industry

· Able to review detailed data and documents

· Able to work effectively and contribute within a team

· Able to work with computer systems

· Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment

Employment Type: Full-time

Available Positions: 1

Location: On-Site

Application Deadline: June 26, 2025

Summary

Manager Of Quality Assurance will be responsible for the development, management, and continuous improvement of quality systems, ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab.

Key Activities

• Host client and regulatory inspections, including preparing and submitting responses to findings.
• Support regulatory activities across all BABM sites within the organization.
• Audit raw data, summary tables, and reports associated with GLP and GCLP protocols to ensure compliance with regulatory requirements.
• Maintain inspection readiness, including preparing and managing site-specific documentation.
• Establish and ensure compliance with GLP, GCLP, and applicable FDA and international regulatory standards.
• Develop and manage the company’s Master Schedule.
• Create, administer, and maintain QA Standard Operating Procedures (SOPs), QA files, and QA audit logs.
• Process, archive, and maintain QA department inspection reports and supporting documentation.
• Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures.
• Author and review SOPs and Statistical Analysis Plans (SAPs).
• Provide GLP and GCLP training to staff.
• Recruit, develop, and mentor QA professionals, fostering a culture of growth and excellence.
• Conduct and report inspections of internal facilities and audits of external vendors to assess compliance with regulatory standards.
• Establish and administer a company Risk Register.
• Identify and address regulatory compliance issues, providing guidance to other departments.
• Deliver monthly compliance status reports to Test Site Management (TSM), highlighting issues and corrective actions.

Preferred Skills

• Proven ability to provide regulatory leadership and guidance in cross-functional and matrixed environments.
• Strategic thinker with strong planning skills and the ability to propose innovative solutions to regulatory challenges.

Educations & Experience

• Bachelor’s degree in biological, chemical, or physical sciences (required); advanced degrees (e.g., Master’s, Ph.D.) preferred.
• 10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience.

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Job ID: 7838

• Oversees Quality Control testing of small molecule therapeutics in clinical development through commercial stage, including late-stage product specification setting and stability program oversight.
• CoA generation and approval
• Collaborates cross-functionally and with external partners to ensure that quality control processes are aligned to the ensuring fit for purpose analytical methods, compliance, and alignment with business needs.
• Accountable for QC OOS/OOT investigations
• Investigates, identifies root cause, and identifies CAPA for testing deviations.
• Authors monitoring and trend reports in support product release and stability.
• Directly manage reference standard and reference material program for assigned products; includes authoring and reviewing associated protocols and reports.
• Along with Analytical Development and Technical Operations, provides input for analytical and microbial method development and testing, technical services and commercial supply support to ensure timely testing. Ensure method transfer and phase appropriate qualification/validation of analytical methods as well as the transfer and validation of methods between testing sites.
• Support QC Systems development, implementation and improvement in accordance with the requirements of cGMP.
• Authors, reviews, or approves SOPs, qualification/validation protocols and reports and change controls as related to Quality Control.
• Supports the establishment and publishing of Key Performance Indicators to track cGMP compliance for the Quality Control function. Captures metric information for use in continuous improvement of areas of responsibility.
• Participates in audits of the laboratories.
  
  

• Master’s Degree and 5+ years’ experience OR Bachelor’s degree with 10+ years of experience.
• QC lab management experience.
• Thorough knowledge of Stability.
• Experience setting specifications and product expirations.
• Deep experience with QC OOS/OOT investigations
• Well versed in various analytical and bioanalytical techniques for small molecule therapeutics
• Working knowledge of quality systems, US regulatory requirements (21 CRF Part 11/210/211,820), and Guidance documents.
• Working knowledge of analytical method validation and methods transfer
• Thorough knowledge of GMPs/cGMPs, SOPs and quality control processes
• Thorough knowledge of technical writing for NDA, BLA, IND, CMC sections.
• Experience with equipment qualification and validation.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with ELN and LIMS desirable.
• Proficient in MS Word, Excel, Power Point and other applications
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities.
• Demonstrated expertise in commercial manufacture.
• Ability to communicate and work in a self-guided manner with internal and external scientific/technical personnel, and all other cross-functions.
• Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.