R&D Product Launch Specialist

Seracare Life Sciences Inc Cumberland Foreside , ME 04110

Posted 2 months ago

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.

Job Purpose

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.

Key Responsibilities

  • 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.

Physical Demands

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.

Work Environment

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sales Support Specialist

Seracare Life Sciences Inc

Posted 5 months ago

VIEW JOBS 9/16/2021 12:00:00 AM 2021-12-15T00:00 Sales Support Specialist LGC Clinical Diagnostics team develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC's products to support accurate and reliable diagnostic results. Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. 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. Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics. Job Purpose: The Sales Support Specialist position will provide direct support for a cross functional Inside Sales Team. Key Responsibilities * Speak to Customers from multiple disciplines in a laboratory setting. * Triage Customers to the appropriate Sales Account Manager and assist in lead generation. * Quotes and literature requests for diverse product line. * Assist Broader Commercial Sales team when necessary * Receive all Technical Calls and Triage appropriately. * CRM updates and maintenance. * Capture new product inquiries. * Other duties as assigned. Knowledge, Experience and Technical Skills * Highly effective oral and written communication skills * 3 - 5 Years customer facing experience * Understanding of Sales process and goals * CRM Experience a plus * Proficient in Microsoft Word and Excel * Ability to multi-task and function independently in a fast paced environment Education and/or Experience * Associates Degree (Bachelor's Degree Preferred) * Five years of relevant work experience * CRM Experience and Customer interfacing highly Preferred * Proficient in Microsoft Office Physical Demands Primarily an office setting, though time in server rooms and in labs may be required No requirement to work in extreme conditions. Work Environment The LGC work environment highly values customer retention, requires continuous professional improvement, meeting high standards of performance, teamwork and attention to detail. The culture and environment promotes positive communication and respect. Take a look at our Cumberland Foreside, ME and Gaithersburg, MD locations: https://youtu.be/rLOb2aYNKuk https://www.youtube.com/watch?v=J2F2A5r3BFo Seracare Life Sciences Inc Cumberland Foreside ME

R&D Product Launch Specialist

Seracare Life Sciences Inc