Stem Cell Production Technician

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Job Description An opening is available within our internal Manufacturing group for a Production Technician. The PT is responsible for the manufacture of therapeutic stem cell products under cGMP conditions. PT is expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, independently perform laboratory tasks (such as pipetting and product sampling) and conduct routine sanitization tasks to maintain facility and equipment. They are expected to demonstrate a strong understanding of cGMP compliance, while operating under supervision, and aseptic technique in handling of products and materials. Primary Accountabilities, Duties and Responsibilities: • Set up, operate equipment, monitor production processes and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate. • Attain qualification for all assigned tasks and maintain individual training plan. • Demonstrate proficiency at laboratory tasks, such as pipetting, sterile filtering and product sampling. • Perform material movements, transfer materials and chemicals in, out, and across the production areas. • Maintain facility and equipment through routine cleaning and sanitization. • Perform other duties as assigned. • Use sophisticated laboratory instrumentation and computer systems to collect and record data. Essential Job Functions • Must be able to accommodate a flexible work schedule (e.g., late afternoon, weekends and holidays) and regular attendance necessary. • Quality Responsibility: Adherence to cGMP is required at all times during the manufacture of stem cell products. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions. • Environmental Demands: The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses. • Physical Demands: Capable of lifting 40 lbs., unassisted. Minimum Required Qualifications/Skills • Education: AS with 2 years biological manufacturing experience; BS preferred • Preferred area of study: Science related discipline • Knowledge: Proven logic and decision-making abilities, critical thinking skills. • Skills: Strong written and verbal communication skills are required. • Qualities & Attitude: Is able to work as part of a team and is open to and actively seeks out feedback on their performance and translates that feedback into action. Please send resumes to hr@hope.bio

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Quality Control Technician

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Job Description Summary An opening is available within our internal Quality Control group for a Quality Control Technician. The main function of this role is to perform quality testing, working in a cleanroom environment while maintaining the high standard of cGMP. A QC Technician is responsible for testing stem cell-based products, including sterility (bacteria, fungi), gram stain, endotoxin, mycoplasma, viability, characterization etc. Other responsibilities include environmental monitoring of the facility, testing sterility and quality of incoming reagents and materials, and generating Certificate of Analysis for all final products. The candidate must be able to accurately and promptly record results of sampling performed. Must be able to maintain the clean room environment, manage appropriate inventory and quickly learn new instrumentation. The ideal candidate will have a solid background in aseptic technique and be willing to learn from, and work closely with, an experienced QC specialist. The candidate will be expected to have a solid understanding of testing and data management and FDA GLP/GTP/GMP standards and requirements. Must be able to accommodate a flexible work schedule (e.g., late afternoon, weekends and holidays) and regular attendance necessary. Other tasks include (but are not limited to): - Laboratory maintenance (equipment maintenance, inventory, decontamination) - Working as part of a Quality Unit to ensure regulatory demands are met - Maintaining training profile and attending all required training Minimum Required Qualifications/Skills: - Education: BS in biology, Microbiology preferred - Strong written and verbal communication skills - Capable of managing time and keeping work-space organized - Computer literate (Windows and Apple based systems) - Willingness to share knowledge and able to operate in a team - Ability to develop, write and review SOPs according to appropriate guidelines Please send resumes to hr@hope.bio

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Quality Assurance Manager

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Job Description:

The Quality Assurance Manager is primarily responsible for ensuring that the stem cell production facility, process, equipment and analytical instruments are validated and maintained in accordance with all cGMP standards, internal policies and best practices within the industry. The ideal candidate is a critical thinker who will proactively improve the qulity systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.

Duties and Responsibilities:

• Develop and maintain overall validation program including facilities, utilities, equipment, analytical instruments, process and sitespecific computerized systems

• Write, review and approve qualification documents to support process validation activities

• Direct validation activities to support cGMP manufacturing

• Proactively conceptualize and establish validation approaches to enhance and optimize current processes

• Prepares SOPs, logs, labels, forms etc. that conform to U.S. FDA requirements

• Create training programs and ensures that technician training is upto-date

• Performs regular audits and mock inspections

• Plans and directs all facility accreditations

• Ensures facility and process compliance with all applicable local, state and federal regulatory agencies

• Responsible for CMC portion of any IND application

• IQ/OQ/PQ

• Provide hands on support to the manufacturing and quality control areas as required to assist in problem solving and product/process improvements.

• Forecast and manage costs and staffing needs

Qualifications

• BA/BS in a scientific or engineering related field

• 5+ years work experience in quality and validation with a strong understanding of GMP and FDA regulations

• Preferably has experience with direct validation responsibilities in cell therapies

• Experience managing internally as well as contracting services

• Experience on new facility startup and/or facility conversion is desirable

• Experience supporting FDA approved, commercial products is desirable

Essential Skills and Abilities

• Excellent written and verbal communication skills at all levels.

• Excellent leadership skills

• Organized

• Can take direction well

• Can multitask

• Can quickly adapt to different circumstances

• Solutiondriven

• Team player

• Must have integrity and most importantly, passionate about their work

This is an opportunity to work with a highly motivated and passionate team that is focused on a common goal: to improve patient’s lives. We are actively seeking individuals who are enthusiastic and can fit into our company culture. We offer competitive pay, excellent benefits and a chance to help build a company that is positioned to lead the future in cellular therapeutics.

Please send resumes to hr@hope.bio

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