R&D Product Launch Specialist
LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics and the Native Antigen Company. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.
We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results.
The R&D product launch specialist plays a role in developing and launching new products for LGC Maine Standards. Under the close direction of his/her supervisor, he/she will be responsible for performing a wide range of duties under LGC Maine Standards' design plan (governed by 21 CFR Part 820 and ISO 13485). This position may also include laboratory bench work if needed.
Assist Research Chemists and Scientists as directed in the launch of new products.
Become familiar with the scientific literature relevant to the products he/she is helping launch
Attend Design Control meetings to take minutes and update DHF with minutes post meeting for the products he/she is helping launch
Assist in the final development of technical protocols, standard operating procedures, spreadsheets, spreadsheet validations and reports, including submission and completion through the QMS system.
Assume responsibility for, under the supervision of a chemist or scientist, stabilities of products post launch, including reagent forecasting, submission of kits and data entry.
Assist in the assembly and maintenance of Design History Files (DHFs) until transfer to QA/RA.
Independent work is expected in carrying out these responsibilities.
Laboratory work, if needed, will include manufacture of stocks and buffers, as well as aiding in RD pilots.
Knowledge, Experience and Technical Skills
This work demands attention to technical detail and documentation according to procedures, and the maintenance of an accurate and comprehensive DHF for products being launched is required.
This position may require some laboratory work. The laboratory work requires the use of personal protective equipment and strict adherence to safety protocols, as well as regular proficiency.
Education and/or Experience
The successful candidate will have a bachelor's degree in Biology, Chemistry, or a related discipline, and knowledge gained from 2-4 years of previous experience.
He/she should be familiar with basic laboratory techniques (i.e. use of volumetric glassware, pipetting, balance use, centrifugation, safety procedures, etc.).
Relevant experience beyond standard course related laboratory work, especially in industry, is preferred.
This position requires an individual who possesses a strong work ethic and has excellent communication, organization, and time-management skills.
He/she must have strong computational skills, good record keeping abilities, and strong skills in PC based programs (MS Word, Excel, etc) as part of daily routines.
This position requires critical attention to detail and collaboration between he/she and multiple scientists.
The physical demands 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.
Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time.
May occasionally be required to lift and move material weighing up to 50 lbs with appropriate equipment.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Agreeable work environment typical of an open office setting with some exposure to noise from office machines.
Will operate in biological and chemical manufacturing environments.
This position will be able to work from home is a potential up to 75% of time, otherwise it will require to be onsite in Cumberland Foreside, ME.
Seracare Life Sciences Inc