It’s an exciting time to join us!

The Andelyn Biosciences’ Manufacturing group is seeking a motivated individual to join our growing team as a Sr. Scientist – Analytical Development.

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.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Development Center 

                  5185 Blazer Pkwy #102

                  Dublin, OH 43017

 

Under the guidance and direction of the Manager – Analytical Development essential functions of the Sr. Scientist – Analytical Development include at a minimum:

·         Execute experiments as directed to satisfy development, qualification, validation, and routine testing as applicable

·         Lead the design and execution of experiments with advice and recommendations from others.

·         Displays proficient technical knowledge of the instruments, assays, and scientific principles used in the laboratory

·         Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occurs at any point during the assigned period of responsibility. 

·         Exercise discretion, judgment and personal responsibility 

·         Demonstrate a high level of integrity

·         Maintain a positive attitude. 

·         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 required training common experience or working knowledge related to the task performed. 

·         Solving, correcting, preventing problems, and performing tasks assigned by leadership. as well as assigning tasks to junior staff 

·         Work to specific measurable objectives requiring operational planning skills 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

·         Infrequent travel required

·         Moderate involvement in audits

·         Moderate involvement in customer relations

·         Moderate responsibility for inspection outcomes

·         Influences hiring, development, and related personnel processes

·         Mentoring and professional development of staff

·         Other duties as assigned 

 

Knowledge, Skills, and Abilities Required

·         Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred

·         Five years relevant experience (w/4 YR deg) OR two years (w/Masters)

·         Experience in biologics or gene therapy required

·         Experience in highly regulated field preferred

·         Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

·         Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting

·         Ability to work independently as well as collaboratively in a diverse and inclusive work environment

·         Must possess a client-focused mindset in daily tasks

·         Must possess prior experience handling confidential information and the ability to maintain confidentiality

 

Minimum Physical Requirements

·         Frequently Sitting

·         Frequently Walking/Standing/Stooping

·         Occasionally Independently lifting up to 50 pounds

·         Frequently Talking on the phone or in-person

·         Frequently Typing on a computer keyboard

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, 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.

 

EOE M/F/Disability/Vet

 

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn.  If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties.