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.
Posting Summary	Rutgers, The State University of New Jersey is seeking a CMC Operator I in GMP/PD Facility at 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: 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). Separates cell subsets for therapeutic use. Cultures cell populations for therapeutic use. Tests the cell products for QC and validation purposes. Real-time data entries into the Electronic Manufacturing Database (EMDB) or the corresponding paper forms approved for the procedure by CINJ QAU. b. Real-time verification of the data entered into the EMDB by co-workers as assigned by the CMC Manager and GMP/PD Facility SOPs. Real-time generation of the Batch Reports. Performs non-GMP procedures under supervision or with detailed instructions. Processes, separates, cultures, manipulates, and tests cell products, biological samples, and chemical products. Conducts in vitro and in vivo studies according to the detailed study plan outlined by the CMC Manager, GMP/PD Facility Director, or PD Manager using existing techniques.
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.
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 year of experience in the field of at least one of the following: health care, biological research, clinical laboratory, immunology, or similar.  Two years 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.
Preferred Qualifications
Equipment Utilized
Physical Demands and Work Environment	PHYSICAL DEMANDS: 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 25 lbs. WORK ENVIRONMENT: 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	Requirements: Internal gowning certification within 3 months post recruitment. Internal certification for sterile technique within (4) four months post recruitment. Yearly vision check followed by correction prescribed by the professional for clear vision. 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.

Posting Details

Posting Number	23ST0299
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.

Affirmative Action/Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement