Scientist I, Analytical Development (Nucleic Based Assays) - Forge Biologics

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.  

About The Role  

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 projects.  The Scientist I, Analytical Development will be responsible for the design and optimization of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays for evaluation of final and in- processes for gene therapy vectors.  This position is also responsible for clear and timely documentation of assay results and communicating data to supervisor, as well as reviewing the data of junior team members.  This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs).

What You'll Do:

• Design and Execute Nucleic Acid Assays: Develop and perform nucleic acid assays for the characterization and quality control of gene therapy products.
• Assay Development and Optimization: Create, optimize, and troubleshoot assay protocols to ensure robustness. This includes, but is not limited to, rAAV titer by ddPCR, sequence identity by NGS, and residual genomic contaminant characterization by PCR and NGS.
• Molecular Assay Leadership: Oversee the design, development, evaluation, and implementation of molecular assays for rAAV characterization and testing, including NGS-based sequencing on both short-read and long-read platforms.
• Independent Research: Conduct independent laboratory research focused on developing and implementing advanced molecular characterization techniques for emerging gene therapy products.
• NGS Protocol Development: Develop and optimize NGS protocols for library preparation, sequencing using Illumina and Oxford Nanopore Technology platforms, and perform library QC and analysis.
• Cross-Functional Collaboration: Work closely with cross-functional teams to integrate NGS assays into other pipelines.
• Workflow Improvement: Continuously enhance NGS workflows by integrating automation and informatics solutions.
• NGS Experimentation and Troubleshooting: Thoroughly understand and troubleshoot NGS experiments to ensure assay robustness and the generation of high-quality data.
• Data Management and Presentation: Adhere to established timelines, maintain accurate records, and present data at team, departmental, and company-wide meetings.
• Technical Documentation and Publication: Author technical reports (Development and qualification reports,) regulatory documents, and manuscripts for publication in peer-reviewed journals.
• Training and Mentorship: Train and mentor junior team members in assay techniques and best practices.

What You'll Bring:

• Educational Background: PhD in Molecular Biology, Biochemistry, or a relevant scientific field (or equivalent) with 2+ years of relevant experience, or MS with 8+ years of relevant experience.
• Genomics Expertise: Extensive experience in genomics, particularly in NGS workflows, with strong leadership and mentorship skills.
• Hands-On NGS Experience: At least 3 years of hands-on experience in NGS library preparation and operation of the Illumina sequencing platform.
• Molecular Biology Proficiency: Deep understanding of molecular biology, with expertise in RNA isolation, cDNA synthesis, PCR amplification, SPRI bead-based cleanup, and fragment analysis.
• NGS Assay Design: Proven ability to design NGS assays and develop strategies to utilize available NGS sequencing tools.
• Laboratory Bench Experience: Significant laboratory experience in developing, validating, and implementing NGS-based and other molecular assays for the analytical characterization and release of gene therapy products.

Work Environment and Physical Demands  

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. 

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

Life at Forge  

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases.Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.  

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key. 

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback. 

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies. 

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals. 

We've Got You Covered 

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. 

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents 
• Flexible PTO (plus 14 paid company holidays) 
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program  
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches