POSITION OVERVIEW

Hope Biosciences is a biopharmaceutical company dedicated to the manufacturing of safe and consistent mesenchymal stem cell products for clinical use in Sugar Land, TX. An opening is available within our company for Production Technician(s). A technician is responsible for the aseptic manufacturing of therapeutic stem cell products while following cGMP regulations. Technicians are required to follow SOPs, prepare raw materials and reagents, monitor and maintain equipment and inventory, and routine sanitization of cGMP suites and open laboratory. 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 & Responsibilities

• Set up, operate equipment, monitor production processes and report production in written and electronic documents in accordance with good manufacturing practice (GMP) and good documentation procedures (GDP), troubleshooting issues and review documentation as appropriate.

• Use sophisticated laboratory instrumentation and computer systems to collect and record data.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Demonstrate proficiency at laboratory tasks, such as pipetting, sterile filtering and product sampling.

• Manage stock level on raw materials and consumables in correct storage conditions.

• Maintain facility and equipment through routine cleaning and sanitization.

• Perform other duties as assigned.

Essential Job Functions

• Must be able to accommodate a flexible work schedule (e.g., late afternoon, weekends and holidays) and regular attendance necessary.

• Must adhere to cGMP 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 serious GMP deficiencies, process deviations, product defects and relevant actions.

• Must be able to work in a cGMP suite setting with full PPE

• Must be capable of lifting 15 lbs., unassisted.

Minimum Required Qualifications/Skills

• Education: Minimum of Bachelor’s in biology or related to relevant science fields

• Knowledge: Proficiency in laboratory environment and aseptic technique preferred.

• Skills: Strong written and verbal communication, critical thinking and decision-making, and ability to work in a fast-paced environment.

• Qualities & Attitude: Attention to detail and able to work with a team as well as individually. Must be open to feedback on their performance and strive for improvement.

Please send resumes to Julie Joo at Julie@hope.bio

COMPANY OVERVIEW:

Hope Biosciences is a biopharmaceutical company developing adult stem cell-based technology for use in a variety of indications.

At Hope, we produce autologous and allogeneic mesenchymal stem cells for use in clinical trials and research. Thus far, our cells have been involved in 27 FDA authorized studies in 14 disease areas, including Alzheimer’s disease, traumatic brain injury, spinal cord injury, cerebral palsy, Parkinson’s disease, osteoarthritis, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), chronic musculoskeletal pain, and COVID-19. To date, Hope has administered more than 150 billion stem cells to patients at $0 cost.

POSITION OVERVIEW:

Hope Biosciences is seeking a Quality Assurance Associate interested in learning aspects of quality assurance in the pharmaceutical and stem cell industry. The associate should expect to gain a general understanding of good documentation practices (GDP), current good manufacturing practices (cGMP), FDA regulations, quality record review, QA operations, compliance, document control, and quality oversight practices.

Location: Sugar Land, Texas

Reports to: Quality Assurance Manager

Duties and Responsibilities:

• Accurately and timely review of in-process, final product, batch record, quality control test record, certificate of analysis, sterility addendum, environmental monitoring records and logs per GDP, cGMP and FDA guidelines

• Write or revise existing SOPs, forms, test records, reports and investigations

• Support compliance of FDA regulations, quality systems and industry standards throughout the facility and by personnel to ensure inspection readiness

• Assist with corrective and preventative actions (CAPAs)

• Enter data and change statuses in Monday.com boards

• Create and present presentations for cGMP trainings

• Provide support during internal and external audits

• Compile data and create graphs for quality management reports, investigations and audit reports Read relevant standard operating procedures (SOPs) and attend cGMP trainings Scan, file and organize quality records

• Assist with projects and tasks as assigned

Essential Skills and Abilities:

• Positive attitude and detail-oriented

• Strong writing and analytical skills

• Organized and self-motivated

• Able to work collaboratively

• Proficient in Microsoft Word and Microsoft Excel

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 with stem cell therapy. We are actively seeking individuals who are enthusiastic to help build a company that is positioned to lead the future in cellular therapeutics.If you are interested in becoming a Quality Assurance Associate at Hope Biosciences, please introduce yourself and email resumes to the Operations Manager, Julie Joo, at julie@hope.bio.

POSITION OVERVIEW

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 clean room 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 candidate will be expected to have a solid understanding of testing and data management and FDA GLP/GTP/GMP standards and requirements.

Duties & Responsibilities 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, biotechnology, microbiology preferred

• Aseptic technique background preferred

• Strong written and verbal communication skills

• Capable of managing time and keeping work-space organized

• Computer literate (Windows and Apple based systems)

• Availability to work on weekends as needed

• Willingness to share knowledge and able to operate in a team

• Ability to develop, write, and review SOPs according to appropriate guidelines

This is a full time position. Please send resumes to Julie Joo at Julie@hope.bio