Senior Manufacturing Associate

4 weeks ago

Los Angeles, United States a GeneCell Therapy company located in Los Angeles, CA Full time

Manufacturing Lead, Gene/Cell Therapy


RESPONSIBILITIES

  • Manufacturing GMP-grade cellular and gene therapy products, following established processes, SOPs, and master batch manufacturing records (includes processing blood, bone marrow, and other cell samples, isolating specific cell populations, preserving samples, and distributing them to appropriate testing laboratories.
  • Performing analyses (such as cell counting, viability determination, mycoplasma assay, endotoxin assay, progenitor cell CFU assays, PCR assays, and potency testing) of clinical samples, verifying results and monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors.
  • Performing quality control during manufacturing, reviewing, and verifying the work of others as assigned.
  • Maintaining records of patient sample and investigational agent storage, applying appropriate labels to incoming and outgoing products, and monitoring product labels and handling during manufacturing.
  • Maintaining cell-processing rooms in accordance with SOPs, including cleaning, environmental monitoring, and stocking reagents and materials.
  • Coordinating with physicians and support staff for the collection of cells from study participants.
  • Receiving and storing cellular therapy products from external sponsors, processing these and other cell therapy products for administration to patients and maintaining logs and proper storage of these products and retained samples.
  • Validating new test methods introduced into the laboratory.
  • Training new and other personnel in the facility.
  • Generating batch records, chain of custody forms, certificates of analysis, and other records, maintaining complete documentation.
  • Obtaining and maintaining all necessary training for work with human samples, including Biosafety, HIPPA, IRB certification, and GMP-specific training.
  • Maintaining complete documentation as required by Federal law.
  • Ordering, receiving, storing, performing quality control, documenting, maintaining, and inventorying materials and reagents.
  • Developing protocols, worksheets, SOPs, and master batch manufacturing records as needed for specific product manufacturing and operations.
  • Performing environmental monitoring of the GMP Facility per established SOPs.
  • Acting as a technical consultant to clinicians, colleagues, and researchers.
  • Serving as a backup to the GMP Facility Manager for managing facility and equipment maintenance, CO2 and LN2 systems, biohazard waste disposal, and assisting with GMP-related training courses.


REQUIREMENTS

  • Minimum 2-5+ years of tissue culture experience.
  • Knowledge and practical experience in aseptic technique/tissue culture.
  • Understanding of GMP requirements and regulations, with previous experience directly involved with federal regulations regarding GLP or GMP.
  • Knowledge of SOPs and Quality Control requirements in a GMP laboratory setting.
  • Ability to work independently and closely follow SOPs.
  • Ability to wear protective clothing for extended periods.
  • Ability to work flexible hours and determine workload priorities to meet deadlines.
  • Strong interpersonal communication skills.
  • Excellent record-keeping skills and good documentation practice.
  • Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice, and Good Manufacturing Practice guidelines.
  • Teamwork skills and ability to prioritize and demonstrate critical thinking.
  • Ability to work independently and collaboratively with multiple departments.
  • Ability to carry out analytical tasks, identify and define issues, resolve problems, and draw logical conclusions.
  • Ability to gather pertinent data, prepare reports, charts, graphs, and tables.
  • Ability to review documents, data, and material compiled by others for completeness and accuracy.
  • Ability to deal with and maintain confidential and sensitive information.
  • Strong decision-making skills and ability to take appropriate action in ambiguous situations.
  • Ability to work on multiple projects simultaneously and organize projects for efficiency.
  • Ability to attend off-site meetings and conferences.
  • Exceptional database and computing skills.
  • Excellent English-writing skills for composing, proofreading, and editing correspondence and reports.
  • Working knowledge of medical and scientific terminology.
  • Demonstrated skill in records management and utilizing computer software for data analysis and report preparation.
  • Ability to learn other software/systems as required.


EDUCATION

  • Bachelor of Science
  • Master of Science or Ph.D. Degree in Biology, Chemistry, or related field is a plus

  • Manufacturing Technician/Associate

    2 weeks ago

    Los Angeles, United States BioPhase Full time

    The Manufacturing Technician/Associate is responosible for ensuring the onstime delivery of quality biopharmaceutical products and supporting cell culture manufacturing. This role reports directly to the Manufacturing Supervisor.**US Citizens or Greencard Holders only**Pay Rate: $25-35/hrLocation: Los Angeles Metropolitan AreaResponsibilities:Perform all...

  • Manufacturing Technician/Associate

    1 month ago

    Los Angeles, United States BioPhase Full time

    The Manufacturing Technician/Associate is responosible for ensuring the onstime delivery of quality biopharmaceutical products and supporting cell culture manufacturing. This role reports directly to the Manufacturing Supervisor.**US Citizens or Greencard Holders only**Pay Rate: $25-35/hrLocation: Los Angeles Metropolitan AreaResponsibilities:Perform all...

  • Manufacturing Technician/Associate

    4 weeks ago

    Los Angeles, United States BioPhase Full time

    The Manufacturing Technician/Associate is responosible for ensuring the onstime delivery of quality biopharmaceutical products and supporting cell culture manufacturing. This role reports directly to the Manufacturing Supervisor.**US Citizens or Greencard Holders only**Pay Rate: $25-35/hrLocation: Los Angeles Metropolitan AreaResponsibilities:Perform all...

  • Senior Manufacturing Engineer, Instruments

    3 weeks ago

    Los Angeles, United States CareerBuilder Full time

    This key role partners with our Contract Manufacturers (CMs) to ensure Supply, Quality, and Cost targets are achieved for successful clinical operations, and commercialization. As the Senior Manufacturing Engineer, you will be a key member of the Operations team. You will represent Cytovale with our Contract Manufacturers (CMs) as both the customer and as...

  • Manufacturing Associate

    4 weeks ago

    Los Angeles, California, United States UCLA Health Full time

    Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Manufacturing Associate (SRA) is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP) and quality control testing of these products to ensure that the products meet the required quality per...

  • Senior Manufacturing Compliance Engineer

    6 days ago

    Los Angeles, United States Kindeva Drug Delivery Full time

    Senior Manufacturing Compliance Engineer 19901 Nordhoff St, Northridge, CA 91324, USA Req #1209 05 April 2024 ROLE SUMMARY The Senior Manufacturing Compliance Engineer position is recognized as an expert internally in the principles and application of quality assurance. This role offers a unique opportunity to contribute your expertise and play a critical...

  • Senior Manufacturing Engineer

    23 hours ago

    Los Angeles, United States Bobrick Full time

    Summary: As a Senior Manufacturing Engineer, you will be a key leader in driving efficiency, quality, and innovation within the manufacturing processes. Leveraging your experience and expertise, you will play a crucial role in optimizing production operations, implementing new technologies, and spearheading continuous improvement initiatives. Collaborating...

  • Lead Manufacturing Associate

    1 month ago

    Los Angeles, California, United States UCLA Health Full time

    Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Lead Manufacturing Associate is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP), quality control testing of these products to ensure that the products meet the required quality, supervise...

  • Senior Manufacturing Engineer

    2 weeks ago

    Los Angeles, United States Bobrick Full time

    Summary: As a Senior Manufacturing Engineer, you will be a key leader in driving efficiency, quality, and innovation within the manufacturing processes. Leveraging your experience and expertise, you will play a crucial role in optimizing production operations, implementing new technologies, and spearheading continuous improvement initiatives. Collaborating...

  • Senior Manufacturing Compliance Engineer

    2 days ago

    Los Angeles, United States Kindeva Drug Delivery Company Full time

    Senior Manufacturing Compliance Engineer 19901 Nordhoff St, Northridge, CA 91324, USA Job Description Posted Friday, April 5, 2024 at 4:00 AM ROLE SUMMARY The Senior Manufacturing Compliance Engineer position is recognized as an expert internally in the principles and application of quality assurance. This role offers a unique opportunity to contribute your...

  • Senior Associate

    1 week ago

    Los Angeles, United States Westmount Asset Management Full time

    Job DescriptionJob DescriptionSalary: Highly competitive compensation and benefits.About WestmountSince we established Westmount in 1990, our vision has been clear. Be an incubator for innovative thinking, whether that’s being one of the earliest firms to adopt a business model that puts clients’ interests first, embracing alternative investments like...

  • Senior Compliance Associate

    2 weeks ago

    Los Angeles, United States Capital Group Companies Full time

    I can succeed as a Senior Compliance Associate at Capital Group. The Code of Ethics Team is dedicated to helping associates observe exemplary standards of integrity, honesty, and trust. It sets out standards for our personal conduct, including pers Associate, Compliance, Compliance Manager, Senior, Operations, Technology

  • Senior Manufacturing Associate

    4 weeks ago

    Los Angeles, United States a GeneCell Therapy company located in Los Angeles, CA Full time

    Manufacturing Lead, Gene/Cell TherapyRESPONSIBILITIESManufacturing GMP-grade cellular and gene therapy products, following established processes, SOPs, and master batch manufacturing records (includes processing blood, bone marrow, and other cell samples, isolating specific cell populations, preserving samples, and distributing them to appropriate testing...

  • Senior Development Associate

    2 weeks ago

    Los Angeles, United States Apple Tree LLC Defunct Full time

    Senior Development Associate The Senior Development Associate will report to the Director of Development and serve as the administrator of the donor database supporting the Development Department. The position will support the planning and execution of – and providing administrative support for – donor relations and special events. The position will also...

  • Senior Associate Attorney

    3 weeks ago

    Los Angeles, United States Pop-Up Talent Full time

    Senior Associate Attorney Los Angeles, CA Base Salary: $100-170k a year BENEFITS: Employers currently pays 100% of employee medical and dental premium (PPO or HMO) Paid Vacation & Sick Days 401k and profit-sharing plan after 1 year of employment Discretionary bonuses RESPONSIBILITIES AS A SENIOR ASSOCIATE: Manage a caseload of complex legal...

  • Senior Associate Attorney

    2 weeks ago

    Los Angeles, United States Pop-Up Talent Full time

    Senior Associate AttorneyLos Angeles, CABase Salary: $100-170k a yearBENEFITS:Employers currently pays 100% of employee medical and dental premium (PPO or HMO)Paid Vacation & Sick Days401k and profit-sharing plan after 1 year of employmentDiscretionary bonusesRESPONSIBILITIES AS A SENIOR ASSOCIATE:Manage a caseload of complex legal matters and prioritize...

  • Senior Associate Attorney

    2 weeks ago

    Los Angeles, United States Pop-Up Talent Full time

    Senior Associate AttorneyLos Angeles, CABase Salary: $100-170k a yearBENEFITS:Employers currently pays 100% of employee medical and dental premium (PPO or HMO)Paid Vacation & Sick Days401k and profit-sharing plan after 1 year of employmentDiscretionary bonusesRESPONSIBILITIES AS A SENIOR ASSOCIATE:Manage a caseload of complex legal matters and prioritize...

  • Senior Associate Attorney

    5 days ago

    Los Angeles, United States Pop-Up Talent Full time

    Senior Associate AttorneyLos Angeles, CABase Salary: $100-170k a yearBENEFITS:Employers currently pays 100% of employee medical and dental premium (PPO or HMO)Paid Vacation & Sick Days401k and profit-sharing plan after 1 year of employmentDiscretionary bonusesRESPONSIBILITIES AS A SENIOR ASSOCIATE:Manage a caseload of complex legal matters and prioritize...

  • Manufacturing Engineer

    4 weeks ago

    Los Angeles, United States Motion Recruitment Full time

    Title: Manufacturing Engineer (Entry to Mid-Senior levels) Location: Orange County, CA (on-site) Duration: Contract Contract Pay: $41-$60/hr. on W2. Summary: The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability...

  • Senior Tax Associate

    2 weeks ago

    Los Angeles, California, United States Consultative Search Group Full time

    A prestigious investment management firm seeks a Senior Tax Associate to join their dynamic team. This position will act oversee and ensure the accuracy and timely completion of company's tax deliverables, and aid in the company's tax initiatives.ResponsibilitiesReview the tax returns prepared by third party tax accountantsCoordinate with third party tax...