Spring Biotechnology Internship 2027 at Cresilon, Inc. | NY, US | Rezi

Spring Biotechnology Internship 2027 at Cresilon, Inc.

Spring Biotechnology Internship 2027

Cresilon, Inc. · NY, US

Yesterday

Spring Biotechnology Internship 2027

Cresilon, Inc. · NY, US

a day ago
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About the Role

Cresilon is offering technical and non-technical internships for the Spring 2027 program, providing exposure to the biotechnology industry. Interns will focus on specific projects and gain a comprehensive understanding of all industry aspects.

Responsibilities

  • Assist in establishing the Quality Management System, serving as the backbone of all quality and regulatory requirements.
  • Help maintain the central document control system, implement OSHA requirements, participate in inspections, and report non-conformances.
  • Provide support to the Quality Operations and Compliance department in maintaining and improving the Quality Management System (QMS).
  • Offer valuable exposure to ISO 13485 and FDA 21 CFR 820 requirements while assisting in day-to-day compliance activities.
  • Improve documentation practices, streamline review processes, and boost departmental efficiency.
  • Assist with product realization efforts, including design verification & validation.
  • Execute software validation activities, including specifications and qualification protocols.
  • Conduct quality risk assessments and author risk documents.
  • Assist with conducting routine research and development on polymer formulation development, physical and chemical characterization of polymer materials, structure-property performance in-vivo, and process scale-up.
  • Write up and present findings for R&D Formulation.
  • Assist with process development, equipment installation and qualification, creation and revision of Standard Operating Procedures (SOPs), fixture design, and process scale-up.
  • Assist with conducting routine research and development on designing, testing, and improving delivery devices for Cresilon's suite of products.
  • Write up and present findings for R&D Product Development.
  • Assist with verifying conformance to in-process specifications and proposing and implementing QC assays.
  • Work with aseptic technique and interface with the manufacturing team.
  • Assist with identifying new/existing data sources, consolidating and merging redundant datasets, creating and populating databases, designing and automating data entry and data reporting functions, and building extensive data analytics dashboards.
  • Support Cresilon’s Regulatory Affairs team in advancing global compliance and market access for its medical device products.
  • Focus on Regulatory Intelligence and global strategic research across multiple markets.
  • Qualify and onboard equipment, work with system implementation, process design, and fixture creation.
  • Work within a QMS, complete paperwork completely and correctly, scan and upload documentation to a validated eQMS, and assist in production as required.

Requirements

  • Background in Chemistry, Biochemistry, Chemical Engineering, Materials Engineering, or similar for R&D Formulation.
  • Prior lab experience required for R&D Formulation.
  • Graduate-level coursework preferred for R&D Formulation.
  • Background in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or similar for R&D Process Development/Engineering.
  • Prior lab experience required for R&D Process Development/Engineering.
  • Industry experience preferred for R&D Process Development/Engineering.
  • Background in Mechanical Engineering, Biomedical Engineering, or similar for R&D Product Development.
  • Prior lab experience required for R&D Product Development.
  • Graduate-level coursework preferred for R&D Product Development.
  • Background in Mechanical, Chemical, or Biomedical Engineering or similar for Manufacturing.
  • Graduate-level coursework and/or industry experience preferred for Manufacturing.
  • Background in Chemistry, Biology, Quality Assurance, or similar for Quality Assurance/Quality Operations & Compliance/Quality Engineering.
  • Currently pursuing Bachelor's or Master's program in Engineering, preferably Biomedical Engineering or Chemical Engineering.
  • Prior lab experience preferred for Quality Assurance/Quality Operations & Compliance/Quality Engineering.
  • Background in Chemistry, Biology, Engineering, or similar for Quality Control.
  • Prior lab experience required for Quality Control.
  • Background in Computer Science, Data Science, or similar for Data Engineering/Business Intelligence.
  • Knowledge of SQL, VBA, Power Query, and/or Python preferred for Data Engineering/Business Intelligence.
  • Knowledge of statistics preferred for Data Engineering/Business Intelligence.
  • Currently pursuing or recently completed a Master’s degree in Regulatory Affairs or a related field (Medical Device coursework preferred) for Regulatory Affairs.
  • Strong theoretical foundation in regulatory principles and frameworks.
  • Prior industry experience is a plus but not required for Regulatory Affairs.
  • A strong passion for regulatory science and a high level of curiosity and eagerness to learn are essential for success in this role.

Skills

  • Hydrogel technology
  • Quality Management System (QMS)
  • OSHA requirements
  • ISO 13485
  • FDA 21 CFR 820
  • Design verification & validation
  • Software validation
  • Quality risk assessments
  • Polymer formulation development
  • Physical and chemical characterization of polymer materials
  • Structure-property performance in-vivo
  • Process scale-up
  • Equipment installation and qualification
  • Standard Operating Procedures (SOPs)
  • Fixture design
  • Delivery device design, testing, and improvement
  • Aseptic technique
  • Data source identification
  • Data consolidation and merging
  • Database creation and population
  • Data entry automation
  • Data reporting automation
  • Data analytics dashboard creation
  • Regulatory Intelligence
  • Global strategic research
  • System implementation
  • eQMS documentation

Location

  • Brooklyn

Work Type

  • Onsite
  • Internship
  • Part time

Experience Level

  • Intern

Education Level

  • Graduate-level coursework preferred
  • Currently pursuing Bachelor's or Master's program
  • Currently pursuing or recently completed a Master’s degree

Salary/Compensations

  • $30.00/hour for 40 hours/week

Benefits

  • Unlimited Monthly MTA metro-card for the duration of the program
  • Free Food & Snacks
  • Happy Hours
  • Eligible for Health Care Plan (Medical, Dental & Vision) for employees working 30 + hours a week
  • FSA (Healthcare & Commuter Benefits) for employees working 30 + hours a week
  • Training
  • Opportunities for compensated travel to conferences and other industry related events

About the Company

  • Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology.
  • The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure.
  • The company's current and future product lines target veterinary, human trauma, and human surgical applications.
  • Cresilon's mission is to save lives.

Equal Opportunity

  • Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
  • We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
  • This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.
  • Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
  • If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process and need an alternative method for applying, please contact our Human Resources Department or email Kduffy@cresilon.com.