Manufacturing Sciences and Technology (MSAT) Scientist I - (Indianapolis)

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

Be responsible for ensuring the successful transition of processes and technologies to and from process development labs. Will be responsible for facilitating the successful transfer of viral vector processes from clients or internal development teams to the manufacturing environment. You will play a critical role in ensuring that processes are seamlessly scaled and adapted to GMP production, enabling the production of Lentiviral, AAV, and Retroviral vectors for gene and cell therapy applications. This role will contribute to the successful delivery of viral vector products, impacting innovative therapies for patients worldwide. 

ESSENTIAL JOB FUNCTIONS / DUTIES

• Ensure seamless transfer of developed processes from PD to production sites. 
• Write, revise, and review documents including batch records, forms, and Standard Operating Procedures (SOP) 
• Create and maintain standard templates and modules used in the generation of technical documents 
• Analyze process performance data from PD and manufacturing runs  
• Research and investigate information to facilitate smooth transition of technology from clients  Work with cross-functional teams to optimize processes for scale-up, ensuring efficiency, robustness, and compliance with regulatory standards. 
• Initiate and manage multiple rounds of document review and ensuing revisions by proactively interacting with all levels of reviewers from subject matter expert to senior management 
• Follow up with reviewers and approvers (subject matter experts) as needed 
• Provide technical expertise in identifying and solving any issues that may arise during the transfer or scaling process. 
• Work closely with teams in manufacturing, quality control (QC), quality assurance (QA), process development, and regulatory affairs to align goals and ensure compliance with cGMP (current Good Manufacturing Practice) requirements. 
• Participate in meetings with external partners or clients to support the tech transfer process and ensure successful handoffs. 
• Assist with validation activities, ensuring processes are robust and reproducible across different scales and production sites. 
• Abide by GLP, GCP, and all company SOPs pertinent to the position 

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

EDUCATION / CERTIFICATIONS / LICENSES

• Bachelor’s or Master’s degree in a scientific discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field

ON-THE-JOB EXPERIENCE

• 2-3 years of Technology Transfer or MSAT experience and technical writing experience
• Knowledge of cGMP, GLP, and regulatory frameworks that govern the manufacturing of biopharmaceutical products

KNOWLEDGE, SKILLS AND EXPERIENCE

• Strong understanding of upstream and downstream processes, particularly in biotech, gene therapy, or biopharmaceutical industries
• Needs strong scientific knowledge, problem-solving abilities, attention to detail, and excellent communication skills to ensure the success of complex transfers from development to manufacturing
• Strong verbal/written and interpersonal communication skills, including excellent grammar and writing skills and computer proficiency
• Technical, communication, and organization skills in a teamwork environment
• Intrinsically motivated, demonstrating both initiative and a