Job Description

JOB DESCRIPTION

Vitranu is a preclinical biotech company, developing a tunable extended-release capsule (TERC™) for sustained release delivery of therapeutics to the eye via intravitreal injection. The Biochemical Technology Manager (BTM) is a key role in the successful development of the company’s technology. Compensation will be commensurate with experience. The position is based in Central Ohio.

The BTM will partner closely with the CEO to develop and execute the company’s operational plans, overseeing workflows, budgets, resources, and timelines relating to research and development activities. Knowledge of the practices, policies and procedures of the biotech industry is essential for the successful planning and implementation of the company’s goals.

The BTM role requires the ability to approach the company’s business with a problem solving and executional mindset, framing decisions through critical thinking and making strategic recommendations.

RESPONSIBILITIES

· Oversee daily project operations, coordinating with internal and external stakeholders

· Translate the company’s strategy into operational plans

· Anticipate, identify and address potential issues with development program

· Manage the budgeting, planning, reporting, and auditing of the product development plan

· Manage relationship with manufacturing development partners, measure and report progress

· Screen and coordinate with vendors and experts to generate and execute a clear development plan (toxicology, PK, CMC development, clinical trial design)

• Analyze budgets and study plans and coordinate contract vendors to ensure all studies are conducted according to plans, timelines, budgets, and relevant guidelines

· Understand and build plans to meet regulatory requirements

· Develop and maintain operational policies and procedures to continually de-risk and add value to the organization

REQUIREMENTS

*An advanced degree in biotechnology, biochemistry, biomedical engineering or similar.

*Experience in drug and/or biotech development from preclinical to clinical trials, managing activities within regulatory development, toxicology, PK, CMC, and clinical trial design and execution.

*Proven experience as a project manager or relevant role.

*Able to manage and coordinate all internal and external activities. Strong communication skills.

*Working knowledge of business infrastructure and MS Office.

*5+ years’ experience in progressive management positions.

*Proven aptitude in decision-making and problem-solving.

Demonstrable competency in strategic planning and business development.

Experience in fundraising will be a plus.

Working knowledge of data analysis and performance/operation metrics.

Outstanding organizational and leadership abilities.

Excellent interpersonal and public speaking skills.

Understanding of advanced business planning and regulatory issues.

A solid grasp of data analysis and performance metrics.

Ability to diagnose problems quickly and have foresight into potential issues.

• Essential requirements