Associate Scientist, Analytical Development (NGS)

Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

Position Overview:

As a member of the Analytical Development group this position will help drive the development of Forge Biologic’s in-house programs as well as client programs.

We are looking for an organized, driven, and detail-oriented associate scientist to perform NGS DNA/RNA workflows, who will have a key role in Research and Development by conducting routine NGS and qPCR workflows to support our day-to-day operations. This position is ideal for candidates who have experience with molecular assays as well as NGS workflows and want to expand their knowledge of diverse NGS applications for infectious disease diagnostics

You will be responsible for the execution and optimization of molecular assays including, but not limited to, DNA extraction, purification, and quantification, Illumina (NGS) sequencing, and Nanopore sequencing supporting the gene therapy analytical development organization. This position is responsible for clear and timely documentation of assay results and communicating data to supervisor. This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs).

Responsibilities:

• Performing product characterization related assays in support of release and characterization, method development/optimization, methods transfer, and analytical support for gene therapy product process development and manufacturing. These include, but may not be limited to, DNA extraction and clean-up, DNA quantification, electrophoretic characterization, and sequencing library preparation.
• Compiling experimental data with minimal oversight, generating reports, and archiving assay data.
• Assist the gene therapy process development team in the analysis and interpretation of assay results.
• Support the analytical and process development group's daily operational needs by maintaining assay instrumentation, controls, standards, and reagent inventories.
• Apply relevant scientific principles and techniques to analytical development problems.
• Maintain detailed, up to date, and reviewed laboratory notebooks.
• Perform and document all test procedures with accuracy, consistency, and timeliness in accordance with laboratory SOPs and regulatory guidelines. Attention to detail and good record-keeping is essential to guarantee the generation of accurate, high-quality data with rapid turnaround times
• Assist with organization and maintenance of inventory, unboxing and storing laboratory supplies, and support in weekly and monthly maintenance of laboratory equipment.
• Participate in key laboratory activities, such as accessioning, aliquoting, handling, and processing of samples. Experimentation includes, but is not limited to, accessioning,
• DNA/RNA extractions, NGS library preparation, qPCR, PCR, QC, and other basic microbiology and molecular biology assays.
• Maintain a high standard of ethics and honesty to meet the quality standards, objectives, and goals of the Analytical Development laboratory

Requirements:

• Degree (BS/BA) in biology, genetics, molecular biology, microbiology, biotechnology, biochemistry, or related discipline with at least one year of work in an academic, pharmaceutical, biotechnology, or Clinical Research Organization (CRO) setting.
• Experience in DNA and RNA manipulation is preferred
• A complete working knowledge of Good Laboratory Practice, Safety Operating Procedure (for BSL-1 and BSL-2 laboratories focused on working with infectious agents), and Good Documentation Practice is required. Understanding HIPAA compliance is required.
• Hands-on’ experience and knowledge in genomics, molecular biology, and microbiology techniques, such as DNA/RNA extraction, PCR, qPCR, cloning, and aseptic techniques.
• Experience in DNA/RNA library preparation workflows, including metagenomics, amplicon, hybrid capture, and RNAseq, as well as operation of Illumina NGS sequencing platforms, is a plus.
• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is preferred
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Ability to work with a high attention to detail
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development
• In our commitment to safety of our employees and customers a COVID vaccination and booster is required