Production Technician

Location: Rockville MD Address: 9950 Medical Center Drive Rockville MD 20850

Duration- 12 months (possibility to extend)

Working Hours/Schedule: 7-5:30 Wed-Sat Onsite FULLY

interview:

2 rounds -

Screening with HM 15 minutes virtual

1 hour interview -onsite -

**In this role contractors must follow proper PPE guidelines outlined by Client.** Jewelry (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. Contactors cannot have recent tattoos or piercings or open wounds.

Introduction: Associate Specialist (Cell Therapy Manufacturing) 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 youre our kind of person. Summary of the group: Join the Clinical Manufacturing Cell Therapy Unit and be a part of producing Clients 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: Bachelors or Masters degree in life sciences engineering or a related field Experience: Bachelors degree and 0-3 years of general cGMP manufacturing experience Masters 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 Why Client At Client when we see an opportunity for change we seize it and make it happen because any opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means were opening new ways to work pioneering cutting edge methods and bringing unexpected teams together. Interested Come and join our journey.