Analytical Development - Scientist Summer Intern
- Andelyn Biosciences is an industry-leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their family. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.
- The Scientist I will be responsible for the execution of various molecular biology, chemistry, microbiology, and protein chemistry assays to support the analytical development of manufactured products. All work is conducted under strict adherence to standard operating procedures and following good documentation practices. Secondary responsibilities include assisting in peer review of analytical development testing documentation, deviation documentation, SOP generation or revision, and other tasks needed to support the primary responsibilities.
- What Will You Be Doing?
- Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
- Attention to detail in all job functions.
- Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
- Identifies problems and performs tasks as assigned.
- Work under the general supervision of senior staff and leadership.
- Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals.
- Documentation of all activities performed according to SOPs.
- Make decisions based on established procedures.
- Nominal fiscal responsibility.
- Exercise discretion, judgment, and personal responsibility.
- Demonstrate a high level of integrity in all aspects of the position.
- Maintain a positive attitude.
- Other duties as assigned.
- What Are We Looking For?
- To fulfill this role successfully, you must possess these minimum qualifications and experience:
- Relevant four-year degree OR relevant Masters OR relevant PhD
- No minimum experience
- Experience in highly regulated field preferred
- Effective communication and interpersonal skills are required.
- Skills in operating a personal computer, and word processor. Must be familiar with various software packages (e.g., Word, Excel, PowerPoint).
- Ability to work with highly confidential materials.
- Minimum Physical Requirements:
- Sitting for extended periods Constantly (67-100%)
- Talking on the phone/in-person Constantly (67-100%)
- Typing on a computer keyboard Constantly (67-100%)
- Standing/walking Occasionally (0-33%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this position. It is not to be construed as an exhaustive list of duties performed by the individual. nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law. As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to the first date of employment. Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.