Downstream Processing

6 months ago

Charlottetown, Canada Next Level Group Full time

Responsibilities:

  • Adhere to the principles of “safety first, quality always”.

  • Perform biologics recovery and purifications using process scale TFF unit, columns, and chromatography system.

  • Operate and maintain production instruments and equipment, such as pH meters, conductivity meters, spectrophotometers, TFF equipment, peristaltic pumps, rotary pumps, and chromatography systems.

  • Perform column packing using packing skids, integrity testing on various types of filters and process analysis using a spectrophotometer.

  • Write and review batch records, SOPs, and qualification documents for the downstream operations.

  • Purchase raw material/ production items and make required updates in SAP.

  • Comply with safety requirements, cGMP, SOP, and manufacturing documentation.

  • Collaborate with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in the successful completion of projects.

  • Work cross-functional with the upstream manufacturing group to provide resources as needed.

  • Perform tasks under minimal supervision, and within tight timelines to meet production schedules.

  • Assist in the maintenance of production equipment in good condition as per manufacturer’s specifications.

  • Responsibilities include cleaning and sterilizing items used in downstreaming applications.

  • Maintain the cleanliness of the production areas and assist in disinfection procedures as needed.

  • Other duties as required.

Qualifications:

  • 2-year biotechnology diploma is required; a Bachelor’s degree or Post-Secondary education in life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.

  • 1-3 years of pharmaceutical/biological manufacturing experience in a GMP environment is preferred.

  • 1-3 years of experience in the purification of biologics using large-scale TFF and chromatography.

  • Process knowledge of TFF filtration and chromatography.

  • Excellent interpersonal skills, both communication and written.

  • Outlines of Production, cGMP guidelines, and HSE regulations.

  • Experience performing investigations and writing deviations.

  • Intermediate/Expert computer skills using MS Office (Word, Excel, PowerPoint).

  • Thorough technical understanding of quality systems and regulatory requirements.

  • Must be able to work shift work (12-hour daytime shifts, 3-4 days/week including some weekends) and overtime as required.

  • Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.

  • Must be able to lift, move and maneuver small-medium sized equipment – up to 25lbs.

  • Requires ability to stand for long periods of time.

  • Requires frequent ladder or stair climbing.

  • Must be able to read, write, understand, and comply with appropriate standard operating procedures.

  • Downstream Processing Specialist

    4 weeks ago

    Charlottetown, Prince Edward Island, Canada Next Level Group Full time

    **Job Summary**We are seeking a highly skilled and experienced Downstream Processing Specialist to join our team at Next Level Group. As a key member of our production operations team, you will be responsible for ensuring the efficient and effective recovery and purification of biologics using process scale TFF units, columns, and chromatography systems.Key...

  • Technician, Operations, Downstream Processing

    5 days ago

    Charlottetown, Canada Merck Sharp & Dohme Full time

    This Technician position is within the Production Department at our Animal Health facility in Charlottetown, Prince Edward Island. The Charlottetown facility manufactures vaccines and biologics used within aquaculture farming. Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using...

  • Technician, Operations, Downstream Processing

    6 hours ago

    Charlottetown, Canada Merck Sharp & Dohme Full time

    This Technician position is within the Production Department at our Animal Health facility in Charlottetown, Prince Edward Island. The Charlottetown facility manufactures vaccines and biologics used within aquaculture farming. Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using...

  • Process Development Scientist, Biologics

    2 months ago

    Charlottetown, Canada BioVectra Inc. Full time

    BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents. **BIOVECTRA Inc.** has an opening for a **Process Development Scientist, Biologics. **This is a permanent, full-time position...

  • Manufacturing Process Technician

    5 days ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    About the RoleWe are seeking an experienced Manufacturing Process Technician to join our team at Elanco. As a key member of our manufacturing team, you will be responsible for ensuring the efficient production of high-quality biologics.Key ResponsibilitiesOperate and maintain large-scale TFF units, columns, and chromatography systems to produce high-quality...

  • Production Technician

    4 weeks ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    Job Summary:We are seeking a highly skilled Production Technician to join our team at Elanco. As a key member of our downstream operations team, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.Key Responsibilities:Operate and maintain production instruments and...

  • Biologics Recovery Specialist

    3 weeks ago

    Charlottetown, Prince Edward Island, Canada Next Level Group Full time

    Job SummaryWe are seeking a highly skilled Biologics Recovery Specialist to join our team at Next Level Group.Key ResponsibilitiesAdhere to Safety and Quality Principles: Ensure a safe working environment and maintain high-quality standards in all aspects of downstream processing.Purification and Recovery: Operate and maintain process scale TFF units,...

  • Production Technician

    3 weeks ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    Job Summary:We are seeking a highly skilled Production Technician to join our team at Elanco. As a key member of our production team, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.Responsibilities:Operate and maintain production instruments and equipment,...

  • Production Technician

    1 month ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    Job SummaryWe are seeking a highly skilled Production Technician to join our team at Elanco. As a key member of our production team, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.ResponsibilitiesOperate and maintain production instruments and equipment, including...

  • Biologics Production Specialist

    4 weeks ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    Job Summary:We are seeking a highly skilled Biologics Production Specialist to join our team at Elanco. In this role, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.Key Responsibilities:Operate and maintain production instruments and equipment, such as pH meters,...

  • Biologics Production Specialist

    4 weeks ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    Job Summary:We are seeking a highly skilled Biologics Production Specialist to join our team at Elanco. As a key member of our production team, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.Responsibilities:Operate and maintain production instruments and...

  • Manufacturing Technician Specialist

    1 week ago

    Charlottetown, Prince Edward Island, Canada Elanco Full time

    Job OverviewThis position is responsible for the recovery and purification of biologics using large-scale TFF units, chromatography systems, and other production instruments.About the RoleThe ideal candidate will have 1+ years of experience in purification of biologics using large scale TFF and chromatography. They will be responsible for operating and...

  • Production Technician- NAV

    6 months ago

    Charlottetown, Canada Elanco Full time

    Responsibilities:Perform biologics recovery and purifications using process scale TFF unit, columns, and chromatography system.Operate and maintain production instruments and equipment, such as pH meters, conductivity meters, spectrophotometer, TFF equipment, peristaltic pumps, rotary pumps, and chromatography systems.Perform column packing using packing...

  • Automation Systems Specialist

    4 weeks ago

    Charlottetown, Prince Edward Island, Canada BioVectra Full time

    Job SummaryBioVectra is seeking a highly skilled Automation Systems Specialist to join our team. As a key member of our automation team, you will be responsible for designing, implementing, and maintaining our facility automation systems.Key ResponsibilitiesProvide technical input for design and fabrication, commissioning, and qualification of facility...

  • Production Specialist

    2 months ago

    Charlottetown, Canada Merck Sharp & Dohme Full time

    **Functions, Duties, Tasks**: - Comply with safety requirements, cGMP (Good Manufacturing Practices), SOP, and manufacturing documentation. - Produce veterinary biologics according to their approved Outline of Product/Product Dossiers and to cGMP (Good Manufacturing Practices) guidelines to meet market demand for the aqua products. - Perform biologics...

  • Production Specialist

    2 months ago

    Charlottetown, Canada Merck Canada Inc. Full time

    Job Description **Functions, Duties, Tasks**: Comply with safety requirements, cGMP (Good Manufacturing Practices), SOP, and manufacturing documentation. Produce veterinary biologics according to their approved Outline of Product/Product Dossiers and to cGMP (Good Manufacturing Practices) guidelines to meet market demand for the aqua products. Perform...

  • Technician, Operations, Fermentation

    4 days ago

    Charlottetown, Canada Merck Sharp & Dohme Full time

    This Technician position is within the Production Department at our Animal Health facility in Charlottetown, Prince Edward Island. The Charlottetown facility manufactures vaccines and biologics used within aquaculture farming. Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using...

  • Technician, Operations

    5 days ago

    Charlottetown, Canada Merck Sharp & Dohme Full time

    This Technician position is within the Production Department at our Animal Health facility in Charlottetown, Prince Edward Island. The Charlottetown facility manufactures vaccines and biologics used within aquaculture farming. Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using...

  • Automation Manager

    5 months ago

    Charlottetown, Canada BioVectra Full time

    The candidate will be responsible for: Serving as technical facility automation engineering subject matter expert responsible for automation system(s) across the entire site including existing site facilities, B100, B200 and/or FFIP. Providing direct technical input for design and fabrication, commissioning, and qualification of facility automation...