Production Technician

Associate Specialist (Cell Therapy Manufacturing)

Location: Rockville, MD Duration- 12 months (possibility to extend) Working Hours/Schedule: Wednesday Saturday 7:00am 5:30pm (first 30-45 days 8:00 am 5:00 pm) x 6 (Fully Onsite)

Interview Length: 1 hour Interview Location: Onsite In this role contractors must follow proper PPE guidelines outlined by Client. Jewellery (including apple watches and fitness bands) are not allowed. Cosmetics are not allowed except non-pigmented/non-scented basic moisturizer and lip balm. Nail polish, artificial nails, eyelash extensions, etc are not allowed. Contractors cannot have recent tattoo's or piercings or open wounds.

Introduction

Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then Client might be the place for you! At Client, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

Summary of the Group

Join the Clinical Manufacturing Cell Therapy Unit and be a part of producing Client's next- generation products as we launch our first wave of cell therapy clinical trials. This position will support the start-up and cGMP operation of the new cell therapy manufacturing facility. Collaboration is key, and you will work together frequently with Process Development, Clinical Operations, Materials Management, and Quality Teams.

Main Duties & Responsibilities:

Author and execute manufacturing batch records, work instructions and/or SOPs, with a focus 'right the first time'. Author and maintain bill of materials. Assist with batch record reconciliation and timely documentation. Documentation of all activities to meet cGMP requirements. Assist with deviations/non-conformances/OOS investigations. Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grades A & B cleanroom environment. Train other personnel on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks. Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as needed. Participate in tech transfer activities. Support process development of platform processes, contributing to the plans and designs of studies/experiments. May modify or improve processes and systems, depending on purpose of experiments Provides technical instruction to the team and allocates administrative work where possible assigning tasks to other manufacturing staff, leading activities on manufacturing floor, communicating to staff about product status at shift change, troubleshooting processing and equipment issues. Ensures a safe work environment in accordance with Client standards. Weekend work may be required.

Education & Experience Requirements

Education: Bachelor's or Master's degree in life sciences, engineering, or a related field Experience: Bachelor's degree and 0-3 years of general cGMP manufacturing experience | Master's degree and 0-2 years of general cGMP manufacturing experience

Required Skills

Basic knowledge in biologics manufacturing process, cell culture and/or vector products. Technical proficiency in aseptic technique and working with manufacturing equipment in open and closed systems. Working knowledge of automated manufacturing equipment and/or process analytical technologies. Proficiency in Microsoft Word, Excel and data analysis.

Desired Skills

Previous manufacturing or process development experience with cell therapy or vector products. Dynamic individual with the ability to communicate and engage others. Independent and self-starting. Ability to work with minimal supervision. Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment.

Manager Top Must Haves

Good communication skills (will be working in different rooms and cross functionally so this is really important for success) Adaptability Aseptic technique/On the floor manufacturing experience