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Manufacturing Specialist III

Marlborough, MA
MARS Solutions Group is looking for an experienced Manufacturing Specialist III Marlborough MA USA. Our client is a leading global Healthcare technologies and digital solutions company with an enduring and innovative presence in the industry. They foster a challenging and empowering environment that cultivates personal and professional growth.

Role Summary
Shift Hours-Sunday through Wednesday, 7:00am to 5:30pm plus overtime as needed
Must be legally authorized to work for any employer in the US without sponsorship
•Looking for Bio-manufacturing candidates with GMP Manufacturing experience working in Cell Culture (Biological Safety Cabinets, Aseptic Techniques, cell Inoculation, small to large scale bioreactors). Making solutions (buffer and media preparation). Protein Purification (downstream processing) utilizing Chromatography columns, viral inactivation, depth filtration, ultra-filtration/DI-filtration and viral filtration. Quality assurance experience is also an attribute that we would like to see on their resume.
•Help us improve access to life-changing therapies that can transform human health
•We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies.
Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
• Responsible for current Good Manufacturing Practices (cGMP) production activities
• Read and perform Manufacturing operations according to Standard Operating Procedures (SOPs) and Master Production Records (MPRs)
• Routinely originate or revise Standard Operating Procedures, Master Production Records and Solution Preparation Records
• Operate and monitor cell culture and/or purification equipment
• Ability to work within ISO 5/7/8 clean room environments
• Review completed cGMP documentation for accuracy
• Operates cGMP Bio-manufacturing equipment, including;
• pH/conductivity meters, single use mixing vessels (XDM’s), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC)
• Performs media and solution preparation
• Performs aseptic techniques within a clean room environment
• Performs small and large scale cell culture production of mammalian cell lines, including cell counting, cell passaging and culture metabolite analysis
• Operates Cell Culture and/or Protein Purification production equipment in a cleanroom environment, including Incubators, Wave Reactors, Single Use Bioreactors (XDR) Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration.
• Knowledge and understanding of document control, calibration, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements
• Works scheduled shift and other off-shift coverage as required
• Works with team leads; engineers, supervisors, and managers to improve quality and process efficiency
• Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management
• Complies with all EHS and Quality policies and procedures
• Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures
• Perform other duties as assigned
Qualifications / Who you are:
• Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 2 years’ experience in biologics manufacturing under cGMP.
• High School Diploma or equivalent with a minimum of 3 years’ experience in biologics manufacturing under cGMP.
• Demonstrates ability to work in a rapidly changing climate and reacts well to change.
• Demonstrates ability to communicate, receive and understand instructions regarding duties to be performed
• Demonstrates strong attention to detail and have quality-minded work habits
• Demonstrates ability to communicate with co-workers and leadership
• Demonstrates ability to follow instruction and standard operating procedures
• Reliable, dependable, and organized
• Able to recognize problems developing, not just occurring
• Ability to work additional hours as needed to support production
• Demonstrates effective written and verbal communication skills

Preferred Qualifications
• Degree in a scientific discipline or equivalent experience.
• Cell Culture experience.
• Protein Purification experience.
• Prior experience working in a cGMP bio pharmaceutical manufacturing environment.
• Experience with single-use bio manufacturing systems

About MARS Solutions Group:
MARS Solutions Group provides a range of opportunities for meaningful work by understanding that employment fit is a combination of people, process, and technology. We leverage our experienced and compassionate team to bring humanity to matching you with the right advanced technology role, and stay connected with you to help you attain your professional goals.
 
 

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