CMC Operator II

Position Details

Position Information

Recruitment/Posting Title CMC Operator II Job Category Staff & Executive

• Facilities/Environmental/Maintenance 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 II in GMP/PD Facility at Rutgers Cancer Institute of New Jersey.

Working under direction of the CMC Manager of the GMP/PD Facility, CMC Operator II assists with technical laboratory procedures and analysis in support of the specialized GMP, PD, and research activities of the GMP Facility and Process Development group and performs all assigned processes and procedures within the scope of services of GMP/PD Facility without the need of close supervision. Independently follows detailed instructions outlined in the SOPs for GMP processes according to the training provided by GMP/PD Facility with additional oversight of the CMC Operator I if designated by CMC Manager of GMP/PD Facility. Performs non-GMP procedures for pre-clinical research under general instructions using prior knowledge and experience. Makes observations of the outcomes or pitfalls of the procedures performed and communicates them to the GMP/PD Facility management. Provides training and oversight to the junior GMP staff as per the assignment of the CMC Manager. 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 Facility according to the guidance and regulations. Assists with root cause analysis.

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.

• Real-time data entries into the Electronic Manufacturing Database (EMDB) or the corresponding paper forms approved for the procedure by CINJ QAU.

• Real-time verification of the data entered into the EMDB by co-workers as assigned by the CMC Manager and GMP/PD Facility SOPs.

• Performs non-GMP procedures under supervision or with detailed instructions.

• Data collection and Data analysis: As needed, collects and analyzes research data and other data on file both from GMP and non-GMP activities.

• Literature review: As assigned, provides review and presentation of scientific or technical information available in the literature.

• 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 22S Position Salary Annual Minimum Salary 59590.000 Annual Mid Range Salary 71303.000 Annual Maximum Salary 84513.000 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

• Master's Degree in Biology or related science with at least 1 year of experience in research related to Immune Cell Biology, Immunology, or Immune Cell Therapies; or Master's Degree in any field with at least 2 years of experience in research related to Immune Cell Therapies; or Bachelor's Degree in the field of medical biosciences, health care, biology, or immunology with 1 year of experience in GMP immune cell manufacturing; or Bachelor's Degree in any other field with at least two years of experience in GMP immune cell manufacturing.

• Three 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.

• 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

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

• 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.

Posting Details

Posting Number 23ST0405 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 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

Supplemental Questions

Required fields are indicated with an asterisk (*).

• How many years of experience in research are related to Immune Cell Biology, Immunology, or Immune Cell Therapies?

(Open Ended Question)

• What is the highest level of education you have completed?

• High School Diploma/GED

• Associate's Degree

• Bachelor's Degree

• Master's Degree

• Ph.D.

Applicant Documents

Required Documents

• Resume/CV

Optional Documents

• Cover Letter/Letter of Application