Job Title: Manufacturing Associate l Job Duration: 6 Months with potential to extend Job Location: Devens, MA Reports To: Manager, Cell Therapy Manufacturing - OO Shift Schedule: (There will be 6-8 weeks of training 7-4pm M-F) After completion of training, they will join the Panama Schedule. Shift: Day:6 AM to 6 PM -
PURPOSE AND SCOPE OF POSITION: Client Cell Therapy Manufacturing seeks Associates within Manufacturing that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.
REQUIRED COMPETENCIES: Education:
High school diploma and 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
Bachelors in relevant science or engineering discipline is preferred
Experience
Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations
Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
Must be able to work in a cleanroom environment and perform aseptic processing
Must be comfortable being exposed to human blood components.
Must be able to be in close proximity to strong magnets.
Preferred Qualifications:
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
DUTIES AND RESPONSIBILITIES: Performing patient process unit operations and support operations described in standard operating procedures and batch records. Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Completing training assignments to ensure the necessary technical skills and knowledge. Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities. Training others on SOPs, Work Instructions to successfully complete manufacturing operations. Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts. Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
PHYSICAL DEMANDS:
Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day. Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials. Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day. Bend and Kneel - Required to bend or kneel several times a day. Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day. Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day. Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day. Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day. Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
Application Process:
Apply online; you can reach us via call and also email.
Application Submission; we will reach out to you over the phone to discuss important aspects of this job opening and upon agreement your profile will be submitted to the client for review.
Interviews; Depending on the size of the selection committee, several interviews are scheduled for each candidate. We will coordinate with candidates to set up interviews with our client.
Job offer; After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on.
Background checks; After Job offer, background checks would be conducted to review candidates’ criminal record, to verify employment history and eligibility, and to run credit checks. Drug testing may also be warranted, depending on the nature of the job.
Onboarding; Based on the background checks, first day reporting details would be shared with candidate upon the client ‘instructions.
Additional information:
This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at NAhr@spectraforce.com if you require a reasonable accommodation
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $27.74/hr.
