Ctcf Gene Jobs in Usa

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics 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. 

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. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.

Job Description: Associate Director or Director, Nonclinical Development

Position Overview:

We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.

Key Responsibilities:

• Study Design & Oversight
• Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
• Select, negotiate, and manage CROs and external partners
• Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
• Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
• Strategic Leadership
• Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
• Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
• Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
• Collaboration & Communication
• Partner with discovery scientists to inform candidate selection strategy
• Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
• Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders

Qualifications:

• PhD in Pharmacology, Toxicology, Biology, or related discipline
• At least 5 years in a biotech/pharma environment
• Experience in drug development for ocular and CNS indications
• Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
• Strong understanding of FDA and ICH guidance on gene therapy
• Proven success in managing CROs and vendors for GLP/non-GLP studies
• Experience integrating nonclinical data into regulatory submissions
• Ability to synthesize complex data sets and communicate effectively across functions
• Ability to travel up to 25% of the time

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.

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.

Open date: October 4, 2025

Next review date: Wednesday, Mar 18, 2026 at 11:59pm (Pacific Time)

Apply by this date to ensure full consideration by the committee.

Final date: Wednesday, Mar 18, 2026 at 11:59pm (Pacific Time)

Applications will continue to be accepted until this date.

The He lab is in the Molecular and Cell Biology department at UC-Berkeley, which encompasses a breadth of disciplines spanning all levels of organization and encompassing diverse organisms. The breath of training, combined with the unique location of Berkeley in the center of biomedical research, offer a nurturing environment for the next-generation scientist to launch on a successful career in biomedical research in academia and industry. The Principal Investigator, Dr. Lin He, was awarded the MacArthur Fellowship (the genius award), the Searle Scholar, a HHMI Faculty Scholar, and is currently a Thomas and Stacey Siebel distinguished chair professor at UC-Berkeley, and a biohub investigator with the Chan-Zuckerberg Initiative (CZI).

The developmental and physiological complexity of a given organism is not governed by the sheer number of protein-coding genes. In mammals, the numerous functional non-coding elements greatly expand gene regulatory modality and diversify functional reservoir. Using human genetics/genomics, mouse genetics/genomics, cell and molecular biology approaches, the He lab at UC-Berkeley has identified a variety of functional non-coding elements, including transposons and non-coding RNAs. Not only do non-coding elements offer important developmental/physiological functions, they also provide us with a unique angle to discover new biological/cellular processes in development and disease. Combining sophisticated genome engineering and innovative live cell imaging, we have pioneered in vivo studies to elucidate the new cellular functions and molecular mechanisms in development and aging. The discoveries of the He lab have been well recognized by publications in prestigious journals, including Nature, Science and Cell. Currently, there are postdoc openings in two projects.

Transposons in mammalian preimplantation development ~40% of mammalian genome originates from transposons, whose abundance greatly exceeds that of protein genes. While historically viewed as degenerated "parasitic" DNAs, transposons yield numerous functional elements for the host genome. These sequences resulted from ancient invasion confer new mechanisms of gene regulation, generate Neogene/ncRNA functions, and provide raw material for genome innovation. Mammalian preimplantation embryos constitute one of the best systems to study transposon-host interactions, as ~20% of their transcriptome results from transposon induction. We aim to characterize the role of specific transposons in preimplantation embryos.

Transposons in aging and disease While specific transposons are integral components of host biology, most mammalian transposons are potentially detrimental to the host genomes, thus inactivated via degenerative mutations and/or transcriptional/post-transcriptional silencing. Interestingly, aberrant transposon induction has been observed in a variety of pathological conditions, including aging, cancer and infection. We aim to investigate the mechanisms underlying transposon dysregulation during reproductive aging and cancer, and to elucidate the effects of transposon-host interactions that accelerate aging and promote cancer.

Postdoc responsibilities:

1) The postdoc will work with the PI to develop a project in one of the two research directions, to comprehensively read literature, to establish appropriate experimental systems, to learn important technologies, and to execute experiments to advance the project and perform data analyses.

2) The postdoc will meet with the PI on a weekly basis to discuss results, to development experimental plans.

2) The postdoc will work with junior lab members to mentor them on specific experimental techniques .

3) The postdoc will contribute to lab duties, which is evenly distributed among all lab members.

Lab:

PhD (or equivalent international degree) or enrolled in a PhD degree program (or equivalent international degree)

Ph.D. (or equivalent international degree) required by the appointment start date. No more than three years of post-degree research experience by the start date.

Ph.D. in developmental biology, Genetics, Genomics, Cell Biology, Molecular Biology, Biochemistry or related field are all welcome to apply. Prior research experiences in mammalian development and disease are preferred.

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• Research Statement - Please discuss research accomplishments and proposed plans. This can include, for example, your publication record, awards, presentations, inclusive research practices that promote the excellence of your research, and areas for future research.
  
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Help contact:

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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.

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: High-Throughput Screening Research Associate II, III (Biodesigner II, III)

Responsibilities:

• Perform massively parallel reporter assays and high-throughput screens across diverse cellular contexts using cellular and molecular readouts.
• Develop and execute molecular biology workflows such as vector design and cloning, DNA/RNA extraction, RT-PCR, qPCR, and next-generation sequencing.
• Support cell culture activities and experiments in multiple cell lines, at small and large scales.
• Design and execute cell-based assays (AAV/lentiviral transduction, transfection, flow cytometry, immunostaining, and other plate reader assays).
• Engineer and characterize cell-based systems using synthetic biology tools and techniques.
• Conduct and troubleshoot experiments, independently and in collaboration with colleagues, to optimize screening throughput, sensitivity, and specificity.
• Proactively troubleshoot technical issues and recommend potential corrective actions based on personal observations and literature searches.
• Prepare summaries of data and present internally to colleagues and management.
• Draft SOPs, follow protocols, diligently document experimental data in lab notebooks, and organize and maintain electronic work records.
• Author scientific reports and data summaries.
• Collaborate with cross-functional teams to meet project goals, bridging early discovery with high-throughput screens to nominate and optimize candidates for further characterization.

Qualifications:

• Bachelor’s or Master’s degree in Biology, Biochemistry, Chemical Engineering, Biological Engineering, or a related field.
• At least 2 years of industry wet lab experience.
• Mammalian cell culture experience (culturing, transfecting and transducing cells, and DNA/RNA purification from cells).
• Molecular biology expertise (vector design and cloning, qPCR, primer and probe design, DNA/RNA extraction workflows)
• Critical thinker with excellent communication skills who thrives in a multidisciplinary, fast-paced team environment.
• Strong written and verbal communication skills.

Preference will be given to those who display:

• High throughput screening assay development in an industry setting.
• High motivation, with a strong work ethic and dedication to generating impact.
• Attention to detail, with the ability to extract deep insights from data.
• First-principles thinking, and an ability to refine one’s intuition based on additional data.
• Ability to go from ideation to data in an independent fashion.
• Long-term personal vision with defined career goals.
• High EQ with team-oriented thinking.
• Experience with pooled, high-throughput screens using next-generation sequencing-based readouts, and/or preparing screening plasmid libraries from synthesized oligo arrays.
• Experience with CRISPR-Cas systems and/or gene editing and delivery technologies.
• Experience preparing next-generation sequencing libraries (Illumina, PacBio, and/or Nanopore platforms).

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.

Senior Commissioning & Qualification Engineer – Automation (Biopharma Build)

Owner’s Representative | Onsite – Spring House, PA

Contract through end of year, potential for ongoing extensions

We are seeking a senior Commissioning & Qualification (C&Q) Automation SME to support the delivery of a state-of-the-art Cell & Gene Therapy manufacturing facility.

This is a high-visibility, onsite role where you will serve as the Owner’s Representative, ensuring highly automated GMP process systems are properly commissioned, integrated, and inspection-ready. If you thrive in complex, automation-heavy capital projects, this is the type of build that defines careers.

What You’ll Be Doing

• Act as the technical SME for commissioning automated process equipment
• Represent the owner’s interests across all project phases
• Lead execution of Commissioning Plans with emphasis on automation, integration, and data integrity
• Author and review IQ/OQ/PQ protocols, URS, and validation documentation
• Oversee startup and field execution for complex equipment platforms
• Drive resolution of automation-related deviations and integration issues
• Coordinate across automation, construction, validation, quality, and vendor teams
• Apply risk-based qualification principles (ASTM E2500, FMEA)
• Ensure compliance with GMP, FDA, and 21 CFR Part 11
• Support digital validation platforms (e.g., Kneat)

Equipment & Systems Scope

• Cell & gene therapy manufacturing systems
• Fill/Finish lines
• Isolators
• Integrated process equipment platforms
• PLC / SCADA / DCS automation layers

What We’re Looking For

Required:

• Bachelor’s degree in Engineering or Life Sciences
• 5–10 years of CQV experience in automated biopharma manufacturing
• Hands-on experience with process equipment and control systems
• Strong understanding of GMP validation lifecycle

Strongly Preferred:

• DeltaV, Rockwell, Siemens, or similar DCS/PLC platforms
• Experience in greenfield or large capital projects
• ASTM E2500 / GAMP 5 knowledge
• Experience with digital validation tools (Kneat, Veeva)
• Background in cell & gene therapy, fill/finish, or cleanroom environments

Why This Role?

• High-impact, automation-heavy greenfield project
• Owner-side authority and visibility
• Complex, integrated GMP systems
• Opportunity to shape commissioning strategy at a flagship facility

EEO Statement:

• Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

The Senior Scientist will play a key role in the development, optimization, transfer, qualification, monitoring, and execution of molecular analytical methods supporting gene therapy process development and/or Manufacturing. If you are looking to be part of a highly technical environment with opportunities for growth and new challenges, this role may be the perfect fit for you!

Responsibilities:

• Lead and execute molecular method development, optimization, transfer, qualification, monitoring, and lifecycle management to support gene therapy process development/manufacturing and transfer to GMP testing.
• Design, perform, and interpret complex experiments with minimal supervision to evaluate vector genomes and related molecular attributes using nucleic acid–based technologies (qPCR, dPCR, ddPCR).
• Provide robust in-process analytics and product characterization support for analytical assays that support Process Development and/or Manufacturing, including support of investigations and technical troubleshooting.
• Present data and project updates at cross-functional meetings and contribute to scientific discussions and decision-making.
• Support analytical method qualification activities, continuous improvement initiatives, and data review processes to ensure scientific rigor and regulatory alignment.
• Work with molecular assays as a primary responsibility and, as needed, support analytical testing across additional assay platforms

Education/ Qualifications:

• Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, Cell Biology, Immunology, or related discipline with 6–10 years of relevant industry experience, or a PhD with 3–5 years of industry experience preferred.
• Demonstrated experience in development, optimization, transfer, and execution of molecular analytical methods, particularly PCR-based assays (qPCR, dPCR/ddPCR) for nucleic acid quantification and characterization.
• Experience supporting gene therapy programs, including molecular assays for vector genome titer, residual DNA analysis, and other nucleic acid–based characterization methods.
• Strong expertise in assay troubleshooting, experimental design, and data analysis to support process development, method qualification, and product characterization

Job Title: QA Consultant (GxP)

Location: San Diego, CA (On-site)

Position Type: Contract / Consultant

Department: Quality Assurance

Reports To: Site Quality Head / Director, QA

Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

About Us

Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.

Position Summary

The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.

You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.

Key Responsibilities

Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.

Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.

Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.

Operate and support legacy Quality systems during the transition to new platforms.

Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.

Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).

Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.

Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).

Support continuous improvement efforts for events within EDMS and LMS.

Work with document owners to ensure timely periodic review of procedures.

Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.

Generate and trend quality metrics, communicating findings to leadership.

Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.

Review and approve paper-based quality documentation and electronic quality records.

Promote a culture of quality, teamwork, and accountability with a patient-first mindset.

Align daily activities with department goals and company values.

Ability to lift up to 20 pounds as needed.

Qualifications

Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).

Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).

Technical Skills:

Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.

Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.

Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.

Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).

Competencies:

Exceptional written and verbal communication skills.

Strong attention to detail and ability to manage multiple projects simultaneously.

Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.

Experience developing training materials and delivering training to employees.

Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.