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 families. 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 Sr. Scientist will be responsible for planning, execution, and analysis of development experiments, developing, qualifying, and validating new equipment and associated process/methods/assays, and extensive writing and documentation (e.g. SOPs and analytical test methods, qualification/validation protocols and reports, etc.). Secondary responsibilities include peer review of analytical development testing documentation, deviation documentation, assist with laboratory investigations, SOP generation or revision, training of junior staff, 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.
- Solving, correcting, preventing problems and performs tasks as assigned by leadership, as well as assigning tasks to junior staff.
- Work to specific measurable objectives requiring operational planning skill with little direct supervision.
- Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals.
- Documentation of all activities performed according to SOPs.
- Make decisions based on established procedures.
- Has fiscal responsibility.
- Influence in hiring, development and related personnel processes.
- May require some travel
- Some involvement in regulatory and client audits
- Some involvement in customer relations
- Some responsibility for inspection outcomes
- Exercise discretion, judgment and personal responsibility.
- Demonstrate high level of integrity in all aspects of the position.
- Maintain 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 Master’s OR relevant PhD
- Six years relevant experience with 4 year degree OR two years relevant experience with Master’s degree OR no minimum experience with PhD.
- Experience in highly regulated field preferred
- Effective communication and interpersonal skills 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%)
EOE M/F/Disability/Vet