Front-line responsibility in manufacturing, assembly, basic testing, packaging and shipping of products in a dry powder media manufacturing environment.
Responsibilities
Read and follow work policies and procedures, EHS, Quality control inspections
Identify and report quality or compliance concerns and take corrective action
Operate within GMPs and Good documentation practices
Follow standard operating procedures for materials handling, equipment operation, and finished goods packaging
The Quality Control Analyst is responsible for completing QC testing related to the manufacturing of autologous CAR‑T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Compensation
The anticipated base pay range for this position is $61,000 to $110,000 USD.
Responsibilities
Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations.
Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
Perform peer review/approval of laboratory data.
Use electronic systems (LIMS, iLAB) for execution and documentation of testing.
Requirements
Bachelor’s or equivalent University Degree in Biology, Biochemistry, Microbiology, or related scientific field
Nice to have: Experience in a Quality Control setting
Nice to have: Experience within Biopharmaceutical or Pharmaceutical industry
Nice to have: Work experience in Cell and/or Gene Therapy or Biologics
Nice to have: Experience with LIMs and SAP or equivalent systems
Apply professional expertise and judgment to support quality compliance activities and business outcomes, focusing on TMTT technologies for heart valve disease patients.
Compensation
The base pay range for this position is $68,000 to $96,000 (highly experienced).
Responsibilities
Assess complaint information and evaluate events for complaint qualification
Manage customer relationships during complaint investigation and resolution
Research and seek input from Product Safety, Engineering, and other departments for complaint investigations
Identify problems and lead projects to improve processes and procedures
Evaluate complaints for Medical Device Reporting (MDR) and prepare/submit MDR reports to FDA
Requirements
Bachelor's Degree in related field
Nice to have: MS Office Suite
Nice to have: Medical device experience (cardiovascular, endovascular, or critical care/surgical products)
An operator is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.
Compensation
$2,500 sign-on bonus eligible!
Responsibilities
Prepare, sterilize, inoculate, and monitor single-use bioreactors and seed-train vessels
Execute sterile media/feed preparation and aseptic sampling for cell count and viability
Set up, operate, and sanitize automated chromatography skids, depth filtration, viral filtration/inactivation, and Tangential Flow Filtration (TFF/UFDF) systems for mAb isolation and purification
Execute and monitor core mAb manufacturing processes (media/buffer prep, upstream/downstream processing, formulation, fill/finish, secondary packaging)
Maintain cGMP compliance in a regulated environment (USDA/FDA/EMA)
The Analytical Quality Assurance (AQA) associate I position is a team contributor role responsible for reviewing and confirming compliance related to raw materials, in-process and finished product analytical documents.
Compensation
$66,300 - $86,000
Responsibilities
Reviewing and confirming the compliance related to raw materials, in-process and finished product analytical documents
Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation
Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs)
Review of laboratory audit trials during data review against standard operating procedures (SOPs)
Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams
Requirements
Bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study
Master’s degree in chemistry, Pharmaceutical Sciences, or related fields of study (preferred)
Nice to have: Master’s degree in chemistry or Pharmaceutical Sciences
Nice to have: Experience in Inhalation products (MDI)
Nice to have: Knowledge of good manufacturing practices and good documentation practices
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
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