Brammer Bio, LLC is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
The Manufacturing Associate I participates in the day to day operation of cGMP compliant production activities in the Manufacturing Department of Brammer Bio in Cambridge, MA.
- Preparation of components and materials for aseptic buffer production operations as well as hands on participation in buffer formulation, filtration, and filling.
- Preparation, sterilization and assembling of all components inherent to process-specific tubing assemblies.
- Perform hands-on activities following detailed protocols, SBRs and SOPs, to complete production runs in an efficient, safe, and correct manner, using the proper equipment and procedures.
- Working with other buffer prep and component prep lab technicians to write and revise documents including SOPs, SBRs, and documents for new processes or equipment.
- Ensure that documents are accurate and reflect the process to be performed.
- Cleaning and preventative maintenance of equipment for GMP operations and will operate equipment such as a pH/conductivity meter, integrity tester, autoclave, pumps, pipettors, fill pumps, etc.
- Cross train and perform hands-on activities in Upstream / Downstream processes as required.
Thermo Fisher offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match. All full time employees are also provided with paid time off, paid company holidays, and an incentive bonus plan.
Thermo Fisher is an Equal Opportunity Employer and participates in eVerify.
Education And/Or Experience:
- A high school diploma and two years of appropriate experience.
- Appropriate college coursework or vocational/technical training may substitute for the required experience.
- Working knowledge of MS Office.
- A bachelor s degree in an appropriate area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry).
- Working knowledge of modern laboratory procedures. Knowledge of cGMP, large scale cell culture and separation and purification techniques.
- Experience with assay development.
- Experience performing assays, e.g. pH measurement, conductivity measurement, ELISA, SDS-PAGE, Western blot, qPCR is a plus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
- The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 40 pounds and occasionally lift and/or move up to 50 pounds.
- The noise level in the work environment is usually moderate.
- Ability to gown aseptically to enter clean room.
- Ability to stand for long periods and wear a respirator if necessary.
Associated topics: bioengineering, bioinformatic, biological engineer, biomaterials, biomedical, medical, neuro, neurodegenerative, nutrition, parenteral