About Nucleus Biologics:

At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. 

Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. 

About the role

• This role will be primarily responsible for driving Core Product Development Initiative, including implementing internal product/process development to support robust customer portfolios. This position will report to Associate Director, MSAT.

What you'll do

• Tech Transfer and onboarding of incoming upstream projects (including Process Performance Validations, Technical Design for Validations, and product FMEAs)
• Drive Core Product Development Initiatives and scale up
• Develop and Review manufacturing Batch Records
• Generate and execute process development studies and technical documentation base on results
• Drive pilot test runs in preparation for onboarding projects
• Develop and improve current and new manufacturing processes
• Work with software engineers to develop automated systems
• Support Project management group with technical support and communication during customer onboarding
• Facilitate clear communication with cross-functional Core Team and stakeholders
• Support integration of regulatory requirements during product commercialization
• Collect and generate data to support analysis for strategic upstream decision making
• Rapid TAT for evaluating onboarding of new projects during feasibility
• Have fun and contribute to a winning culture

Qualifications

EDUCATION: 

• Requires a BS or MS degree in Chemistry, Biochemistry, Organic Chemistry, Chemical Engineering or related field
• BS degree: 4+ years of related experience
• MS degree: 3+ years of related experience

 REQUIRED EXPERIENCE: 

• Must thrive in a fast paced, start-up environment and must be able to meet critical deadlines
• Previous work experience in life science, pharma or biotech industries preferred Ability to self-manage multiple projects and priorities simultaneously
• Previous experience with new product introduction and commercialization
• Development of SOPs, BRs, WI
• Strong fundamental knowledge in chemistry
• Hands-on experience handling lab equipment, mixers, pH meter, Osmometer, conductivity meters
• Proficient in understanding Good Manufacturing Practices (GMP) and how GMP applies to the development of a process
• Intermediate to advanced skills in Word, Excel and PowerPoint
• Detail-oriented and process driven
• Strong Problem solving and decision making skills
• Good written and oral communication skills
• General understanding of software systems and AI language models is a plus
• Familiarity with ISO 13485 a plus

PHYSICAL REQUIREMENTS: 

• Ability to hear and speak to employees and external associates on the phone and in person
• Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
• Ability to lift 30 lbs. to a height of 3-4 feet on a regular basis

TRAVEL REQUIREMENTS: 

• May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position. 

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.