Job description
Position Details
Position Information
Recruitment/Posting Title
CMC Operator I
Job Category
Staff & Executive - Research (Laboratory/Non-Laboratory)
Department
Cancer Institute of New Jersey
Overview
Our vision is to be a statewide, national and world leader of scientific discovery, transdisciplinary engagement, translation, patient care and education that improves outcomes for cancer patients and populations.
We will accomplish this by conducting innovative basic, clinical and population research and cutting-edge patient-centered care that expands our understanding of the etiology and biology of cancer; facilitates the rapid translation of laboratory-based discoveries into human studies; develops new approaches and interventions for cancer prevention that decrease cancer incidence and mortality; and develops new and better therapies to decrease suffering and mortality from cancer.
Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.
We will accomplish this by conducting innovative basic, clinical and population research and cutting-edge patient-centered care that expands our understanding of the etiology and biology of cancer; facilitates the rapid translation of laboratory-based discoveries into human studies; develops new approaches and interventions for cancer prevention that decrease cancer incidence and mortality; and develops new and better therapies to decrease suffering and mortality from cancer.
Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.
Posting Summary
Rutgers, The State University of New Jersey is seeking a CMC Operator I in GMP/PD Facility within Rutgers Cancer Institute of New Jersey.
Under the direction of the CMC Manager or CMC Coordinator of the GMP/PD Facility, CMC Operator I assists with technical laboratory procedures and analyses in support of the specialized GMP, PD, and research activities of the GMP Facility and Process Development group. Working under supervision of the CMC Manager, performs all assigned processes and procedures within the scope of services of GMP/PD Facility under close supervision. Follows detailed instructions outlined in the SOPs for GMP processes according to the training provided by GMP Facility with additional oversight of the CMC Operator II. Performs non-GMP procedures for pre-clinical research under detailed instructions with close supervision. Monitors supplies, reagents, and equipment required for the procedures to be done. Generates thorough documentation (paper-based and electronic) for GMP and non-GMP processing in GMP/PD according to the guidance and regulations.
Among the key duties of this position are the following:
Under the direction of the CMC Manager or CMC Coordinator of the GMP/PD Facility, CMC Operator I assists with technical laboratory procedures and analyses in support of the specialized GMP, PD, and research activities of the GMP Facility and Process Development group. Working under supervision of the CMC Manager, performs all assigned processes and procedures within the scope of services of GMP/PD Facility under close supervision. Follows detailed instructions outlined in the SOPs for GMP processes according to the training provided by GMP Facility with additional oversight of the CMC Operator II. Performs non-GMP procedures for pre-clinical research under detailed instructions with close supervision. Monitors supplies, reagents, and equipment required for the procedures to be done. Generates thorough documentation (paper-based and electronic) for GMP and non-GMP processing in GMP/PD according to the guidance and regulations.
Among the key duties of this position are the following:
- Processes clinical samples received by GMP/PD Facility for clinical testing.
- Processes clinical samples received for manufacturing of the Investigational New Drug (IND) products for clinical trials and Single Patient Use (SPUs).
- Responsible for proper documentation of all manufacturing and processing steps of GMP production according to the rules and regulations.
- Processes, separates, cultures, manipulates, and tests cell products, biological samples, and chemical products.
- As needed, collects and analyzes research data and other data on file both from GMP and non-GMP activities.
- As assigned, provides review and presentation of scientific or technical information available in the literature.
- Executes activities including but not limited to cell culturing, production of viral supernatants, transduction, transfection, flow cytometry, cytolysis assays, cytokine assays, proliferation assays, PCR, and other analyses of human samples.
- Shares responsibility for responding to after-hours emergencies related to cell processing and equipment monitoring.
Position Status
Full Time
Hours Per Week
Daily Work Shift
Work Arrangement
FLSA
Exempt
Grade
20S
Position Salary
Annual Minimum Salary
51688.000
Annual Mid Range Salary
61720.000
Annual Maximum Salary
73062.000
Standard Hours
37.50
Union Description
HPAE, Local 5094
Payroll Designation
PeopleSoft
Benefits
Rutgers offers a comprehensive benefit program to eligible employees. For details, please go to http://uhr.rutgers.edu/benefits/benefits-overview.
Rutgers also offers a benefit program to eligible full-time postdoctoral fellow students. For details, please go to https://finance.rutgers.edu/healthcare-risk/insurance/postdoctoral-health-insurance.
Rutgers also offers a benefit program to eligible full-time postdoctoral fellow students. For details, please go to https://finance.rutgers.edu/healthcare-risk/insurance/postdoctoral-health-insurance.
Seniority Unit
Terms of Appointment
Staff - 12 month
Position Pension Eligibility
ABP
Qualifications
Minimum Education and Experience
- Bachelor’s Degree in the field of medical biosciences, health care, biology, or immunology without any prior relevant work experience or Bachelor’s Degree in any field with a minimum of one (1) year of experience in the field of at least one of the following: health cay, or similar.
- Two (2) years, biological research, clinical laboratory, immunology or more of experience in GMP Facility and GMP training plus a high school diploma may be substituted for the education requirements.
Certifications/Licenses
Required Knowledge, Skills, and Abilities
- Effective oral and written communication skills.
- Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
- Ability to work full time in sterile environment (in clean GMP suites).
- Shared Responsibility for responding to after-hours emergencies in cell processing and equipment monitoring
on rotation schedule. - Flexible work schedule may be required.
Preferred Qualifications
Equipment Utilized
Physical Demands and Work Environment
- Standing, sitting, walking, talking, and hearing.
- Participation in GMP manufacturing requires yearly vision check and appropriate correction as prescribed by the health care professional.
- Lifting up to 25lbs.
- Laboratory environment.
- Moderate noise.
- Exposure to blood, tissue samples, excrement, antineoplastic drugs, and possible exposure to radioactive materials and infectious and communicable diseases.
- Universal precautions are mandatory.
- Exposure to hazardous chemicals.
- Flexible work schedule may be required.
Special Conditions
- Internal gowning certification within three (3) months post recruitment.
- Internal certification for sterile technique within four (4) months post recruitment.
- Yearly vision check followed by correction prescribed by the professional for clear vision.
Posting Details
Posting Number
23ST1046
Posting Open Date
Special Instructions to Applicants
Regional Campus
Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus
Downtown New Brunswick
City
New Brunswick
State
NJ
Location Details
Pre-employment Screenings
All offers of employment are contingent upon successful completion of all pre-employment screenings.
Immunization Requirements
Under Policy 60.1.35 Immunization Policy for Rutgers Employees and Prospective Employees, Rutgers University requires all prospective employees to provide proof that they are fully vaccinated and have received a booster (where eligible) against COVID-19 prior to commencement of employment, unless the University has granted the individual a medical or religious exemption. Employees who are not eligible for a booster at the time of an offer of employment must provide proof they have received a booster upon eligibility and upload proof of same. Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate’s offer of employment or disciplinary action up to and including termination.
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