Entry Level Manufacturing Associate

Company: Minaris Regenerative Medicine
Location: Mountain View
Posted on: February 21, 2021

Job Description:

The Role:
Experience level: Entry level Experience required: 0-2 Years Education level: Bachelor's degree Job function: Manufacturing Industry: Biotechnology Total position: 2
Relocation assistance: No Visa: Only US citizens and Greencard holders
The Role: Under the supervision of the Associate Manager, the Manufacturing Associate processes, cultures, cryopreserved, and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP, and GMP practices. Facility and personnel-specific responsibilities will be regulated by the company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal, and written communication skills, and be flexible in their working hours. Essential Functions and Responsibilities

• Performs any and all required processing and manipulation required to produce and assess safe and efficacious products
• Proficiently functions within ISO Class 7 and 6 cleanroom environments, ensuring personal and product safety
• Consistently produce a high level of documentation accuracy and clarity
• Performs cryopreservation of products using DMSO based solutions and controlled-rate freezers
• Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra-cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices
• Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints
• Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media, and reagent preparation.
• Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures
• Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures
• Notifying management of any deviation that may occur during processing or during equipment maintenance. Performing investigations for deviations and completing deviations in a timely manner
• Participate in the on-call program
  Qualifications
  • Bachelor's degree or Associate's Degree in a biologics or related field preferred
  • A minimum of 1 year of applicable experience in a clinical laboratory, hematology, blood banking, immunology, or cGMP manufacturing
  • Current Medical Technologist license or equivalent is a plus
  • Aseptic/cell processing and clean room experience preferred
  • Demonstrates tact and courtesy in dealing with others
  • Strong work ethic, methodical approach to new challenges
  • GLP and GMP experience a plus
  • Must be able to work independently and with minimal supervision
  • Able to work in a fast-paced environment at times under pressure and with tight deadlines
  • Excellent organizational skills and attention to detail
  • Good verbal and written communication skills
  • Strong team-oriented interpersonal skills are essential
    Competencies/Candidate Profile:
    • Ability to think strategically and tactically (detail-oriented)
    • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
    • Analytical and problem-solving skills
    • Strong written and oral communication skills
    • The ability to the multi-task team is essential
    • Flexible and able to adapt to company growth and evolving responsibilities
    • Ability to work a flexible schedule that may include nights, weekends, and/or holidays Aseptic Processing Standards
      • The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role. Minimum Required Training to Be Completed within the first 90 days of hire
        • GMP training
        • Gowning training/qualification
        • Aseptic process qualification (personal media fill) Working Environment
          • Must have the ability to work in a team-oriented environment and with clients
          • Must be able to work during the weekend, holidays and as required by the company
          • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
          • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
          • Must have the ability to work in the cleanroom environment for an extended period of time
          • Must have the ability to work with specialized equipment
          • Must be able to handle the standard/moderate noise of the manufacturing facility

Keywords: Minaris Regenerative Medicine, Mountain View , Entry Level Manufacturing Associate, Other , Mountain View, California