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Quality Control (QC) Scientist to NorthX Biologics, Solna

Ansök    Mar 31    NorthX Biologics AB    Molekylärbiolog
We are now looking for a QC Scientist to join our Analytics team, at our Stockholm site, with a starting date at the earliest convenience. The position is full-time and on a fixed-term contract for 1,5 years. NorthX Biologics is a Contract Development and Manufacturing Organization (CDMO) that offer services and support in the development and manufacturing of biologics used in vaccines, gene/cell therapy and other advanced applications. We have a long trad... Visa mer
We are now looking for a QC Scientist to join our Analytics team, at our Stockholm site, with a starting date at the earliest convenience. The position is full-time and on a fixed-term contract for 1,5 years.
NorthX Biologics is a Contract Development and Manufacturing Organization (CDMO) that offer services and support in the development and manufacturing of biologics used in vaccines, gene/cell therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognized as a national innovation hub for advanced therapeutics and vaccines and have expanded our development capabilities to serve our clients. This includes a new development organization with cutting edge laboratories and technologies.
As a QC Scientist, you will be working with scientific tasks to prove that our analytical methods and equipment are suitable and functional as intended. You will be responsible for performing routine and non-routine analyses using immunoassays (e.g. ELISA, ICC, WB), assay improvements as well as method validations and analytical equipment qualifications to establish new methods and technology. You will collaborate with dedicated team members and other departments within the organization to ensure that we meet our customer requirements.
This is an excellent opportunity to strengthen your industrial experience and join a great company with an exciting journey ahead. If this sounds interesting to you - Come join us!
RESPONSIBILITIES
The Analytics team at NorthX Biolgics works to ensure the highest quality standards for all products, processes, and services provided by the company. As a QC Scientist, your main responsibilities areas and daily tasks include:

Molecular biological analysis work


QC testing and raw data review


Plan and report method transfer and validation.


Write and update protocols, reports, instructions, and other documents.


Analytical development of complex assays


Coordinate activities with internal and external partners.


Plan, execute and report participate in qualification of equipment


Participate in client projects and meetings.


Report deviations


Perform maintenance on instruments and premises.


Assist team though technical support and reconciling knowledge and skills


YOUR PROFILE
Key Qualifications for the position include:

Minimum a MSc in Biology, biochemistry or relevant field.


Experience of working in a laboratory environment.


Proven ability to execute, troubleshoot, and optimize analytical assays.


Hands-on experience in working with molecular biology methods and immunoassays such as ELISA, ICC, WB.


Experience of analysis using cell-based assays is a plus.


Experience in working in a GMP regulated laboratory is a plus.


Excellent communication skills in English, both in speaking and in writing, is a requirement. Swedish is a plus.


We are looking for a positive and analytical team player with a can-do attitude, strong laboratory skills and an excellent capability for problem-solving. You enjoy taking on responsibility and planning and organizing your work effectively to manage multiple tasks and priorities in a timely manner. You are flexible, resilient and thrive in a dynamic workplace where people matter and everyone works together to make a positive impact.
If you are passionate about making a difference and have the skills and experience to excel in this role, we invite you to apply today!
ABOUT NORTHX BIOLOGICS
NorthX Biologics is an expanding company within an exciting field, working with customers and projects globally. For the right candidate we are offering a position with strong opportunities for personal development. NorthX value the work-life-balance for employees and offers flexibility in planning your workdays and hours. To learn more, please visit https://www.nxbio.com/ Visa mindre

Administratör

Ansök    Dec 5    NorthX Biologics AB    Administratör
NorthX Biologics AB, ('NorthX'), med två tillverkningsanläggningar i Sverige, i Solna och huvudkontor i Matfors är en ledande nordisk utvecklings- och tillverkningsorganisation med fokus på avancerade biologiska läkemedel, CGT (cell- och genterapi) och vacciner. Tillsammans med Vinnova har NorthX också uppdraget att etablera en innovationshub för att stärka Sverige inom utveckling och produktion av avancerade läkemedel. Verksamheten är styrd av läkemedelsi... Visa mer
NorthX Biologics AB, ('NorthX'), med två tillverkningsanläggningar i Sverige, i Solna och huvudkontor i Matfors är en ledande nordisk utvecklings- och tillverkningsorganisation med fokus på avancerade biologiska läkemedel, CGT (cell- och genterapi) och vacciner. Tillsammans med Vinnova har NorthX också uppdraget att etablera en innovationshub för att stärka Sverige inom utveckling och produktion av avancerade läkemedel. Verksamheten är styrd av läkemedelsindustrins kvalitetsstandard GMP (Good Manufacturing Practice) där kvalitet och spårbarhet är viktiga komponenter. Följ med på vår resa. För mer information: www.nxbio.com
 
Vi förstärker vår Admin & Accounting avdelning som är stationerad i Matfors och söker nu en erfaren administratör till vår anläggning i Solna. Du kommer att ingå i ett team som arbetar brett mot större delen av företaget över båda våra anläggningar.
 
Exempel på förekommande uppgifter:
 
-        Inkommande växelsamtal/besökshantering
-        Löpande administrering
-        Resebokningar (interna resor)
-        Arkiv
-        Supportärenden (dokument, system etc)
-        Loggbok- och objektshantering
-        GDPR arbete
-        Utbildningar
 
Dokumentera utförda arbetsuppgifter, initiera avvikelser och ändringsärenden. Att uppdatera instruktioner ingår även i det dagliga arbetet. Resor kan också förekomma i liten utsträckning. 
 
Du arbetar självständigt men under givna instruktioner. Stora delar av arbetet sker enligt kvalitetssystemet för läkemedelsproduktion GMP (Good Manufacturing Practice). 
 
 
Vi söker dig som är strukturerad med ett stort eget driv samt besitter en hög servicekänsla och god lösningsförmåga. Du skall vara engagerad, stresstålig och bekväm med att arbeta med många saker parallellt. Vi förutsätter att du är kvalitetsmedveten och noggrann i ditt arbete samt besitter en god samarbetsförmåga.
Då vi befinner oss i en förändringsresa är det viktigt att du är flexibel och trivs i en fartfylld miljö där omväxling mellan varierande uppgifter och system är en del i vardagen.
 
 
Ett krav för sökande är

Verkat inom processindustrin, läkemedelsbranschen eller annan kvalitetsstyrd tillverkningsindustri samt har erfarenhet av kvalitetsledningssystem som GMP (Good Manufacturing Practice


Goda kunskaper inom Officepaketet


God systemvana


 
Utbildning och erfarenhet:

Gymnasieutbildning


Minst 3 års erfarenhet av administrativt arbete


God kommunikationsförmåga i tal och skrift, både på svenska och engelska


 
Om du har en passion för administrativa uppgifter och vill bli en del av vårt dedikerade team, ser vi fram emot din ansökan. Erfarenhet av utläggshantering/fakturakontering eller GDPR arbete är meriterande.
 
Tjänsten rapporterar till chefen för Admin & Accounting och är en tillsvidareanställning.
 
För ytterligare information kontakta:
 
Maria Melin, Head of Admin & Accounting                          [email protected]
Akademikerna, Lina Kejerhag                                                 [email protected]
Unionen, Jan Atterhagen                                                          [email protected] Visa mindre

Laboratory Engineer

NorthX Biologics is a Contract Development and Manufacturing Organization [CDMO] that offer services and support in the development and manufacturing of biologics used in vaccines, gene therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognised as a national innovation hub for advanced therapeutics and vaccines and have expanded our devel... Visa mer
NorthX Biologics is a Contract Development and Manufacturing Organization [CDMO] that offer services and support in the development and manufacturing of biologics used in vaccines, gene therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognised as a national innovation hub for advanced therapeutics and vaccines and have expanded our development capabilities to serve our clients. This includes a new development organisation with cutting edge laboratories and technologies.

We are looking for a Laboratory Engineer to join our Analytics team, at our Stockholm site, with starting date at the earliest convenience.

You will be preforming quality control analysis using broad range of methods, including molecular biology assays, cell-based assays, micro biological assays and HPLC. You will be planning, executing, and reporting experiments to develop robust and reproducible methods that can be validated for GMP. You will be working extensively hands-on in the laboratory, but also responsible for maintenance of qualified status of room and laboratories and instruments, as wells as documenting and writing.

For this position we require a minimum a BSc in Biology, Chemistry, or relevant field, and at least 1+ years of GMP experience from the pharmaceutical industry. You must be able to demonstrate strong written and verbal communication skills and be fluent in English and Swedish.

Technical skills required for the position.
Molecular biology methods such as ELISA, qPCR, Westen blot, SDS

· Cell Culture using aseptic techniques
HPLC protein analysis
Basic microbiology

Examples of daily work tasks:
Planning, executing, analysing and reporting of routine QC analysis
Develop and troubleshoot protocols and methods

· Work accordance with appropriate Safety, Health & Environment standards
· Work accordance with quality and compliance standards i.e. GMP
Participate in method transfer for GMP validation
Laboratory maintenance
Ordering materials and reagents
Upkeep of inventory lists
Writing, implementing, and updating documentation
Performing deviation investigations
Maintaining the qualified status of instruments.

As a person, you are responsible, meticulous and find it easy to cooperate with others as well as to work independently. You enjoy working in a structured laboratory environment according to established routines. You love to solve problems by thinking outside the box and you have an eye for details. You have a calm, rigorous and focused approach to experimental. Finally, you are a positive person who is flexible in terms of your daily tasks. Visa mindre

Scientist

Ansök    Apr 10    NorthX Biologics AB    Kemist
NorthX Biologics is a Contract Development and Manufacturing Organization that offer services and support in the development and manufacturing of biologics used in vaccines, gene therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognized as a national innovation hub for advanced therapeutics and vaccines and have expanded our development ... Visa mer
NorthX Biologics is a Contract Development and Manufacturing Organization that offer services and support in the development and manufacturing of biologics used in vaccines, gene therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognized as a national innovation hub for advanced therapeutics and vaccines and have expanded our development capabilities to serve our clients. This includes a new development organization with cutting edge laboratories and technologies.

We are now looking for a Scientist to join our Analytics team, at our Stockholm site, with starting date at the earliest convenience.

You will be working with scientific tasks to prove that our analytical methods and equipment are suitable and functional as intended, e.g. validation and qualification. You will be working with method validation and analytical equipment qualifications to establish new methods and technology, as well as verification of existing methods (e.g. pharmacopeial methods) and requalification of equipment. As a contract manufacturer we are constantly adding new methods and equipment to our portfolio, often specialized to our customer needs, i.e. phase appropriate method validation. As such, broad experience from method validation and/or analysis of biologics is an advantage. Some of our main analytical methods are HPLC-based and HPLC experience is therefore highly meriting.

We expect that applicants have a university degree of MSc within a relevant field for working in the Biopharmaceutical industry. For this recruitment we prefer an experienced candidates with 3+ years of experience from the pharmaceutical industry.

Technical skills that are meriting are listed below.
Technical skills
Highly meriting
Preferred
Validation of analytical methods, especially for biologics
Cell culture
HPLC experience
Cell-based assays
Molecular biology methods (gels, qPCR, ELISA etc.)
Basic microbiology
Analytical equipment qualification
Stability study planning and monitoring
Lab incident, deviation, and OOS management
Computerized systems qualification


Examples of daily work tasks:
Planning and reporting method validations.
Planning, executing, and reporting analytical equipment qualifications.
Troubleshoot existing protocols and methods.
Support the team with expertise to enable development of robust methods.

· Procurement commissioning and testing of analytical instruments.
· Provide expertise to other departments.
Participate in client projects and meetings.
Plan tech transfers/method transfers from clients
Support laboratory work in conjunction with method validation
Routine QC laboratory work
Risk assessments and change control.
Lab incident, deviation, and OOS management.
Tasks depending on individual expertise.


The nature of the position is both administrative and, hands-on with analytical methods and equipment. A calm, technical and focused approach to scientific work is critical to succeed in this role. You must be able to demonstrate strong written and verbal communication skills and be fluent in English and Swedish. We are small and highly collaborative group, and you are expected to bring a positive force to the team and be prepared to assist where needed. Visa mindre

Sr Project Manager

Ansök    Sep 20    NorthX Biologics AB    Biokemist
NorthX Biologics is a Contract Development and Manufacturing Organization that offer services and support in the development and manufacturing of biologics for vaccines, gene/cell therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since the early 90-ies. We are a recognized national innovation hub for advanced therapeutics and vaccines and have expanded our development... Visa mer
NorthX Biologics is a Contract Development and Manufacturing Organization that offer services and support in the development and manufacturing of biologics for vaccines, gene/cell therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since the early 90-ies. We are a recognized national innovation hub for advanced therapeutics and vaccines and have expanded our development capabilities to serve our clients.
Are you an experienced Project Manager with a passion for driving success and an interest in CMC? Do you thrive in a fast-paced environment where innovation and collaboration are at the forefront? If so, you may be NorthX next Project Manager.
 
We are looking for a skilled individual to lead our client programs ensuring efficient execution in order to make breakthrough treatments available for the patients.  Projects are ranging from shorter R&D projects to full manufacturing programs including all aspects of clinical manufacturing.   
 
Key Responsibilities: 

Lead and manage end-to-end project delivery, ensuring successful completion within scope, budget, and timeline.


Collaborate with cross-functional teams to define project objectives, requirements, and deliverables.


Develop comprehensive project plans, track progress and finances, and proactively identify and address potential issues.


Effectively communicate project status, risks, and mitigation strategies to stakeholders at all levels.


Foster a positive and collaborative team environment, motivating and supporting team members to achieve project goals.


Continuously evaluate and improve project management processes to enhance overall efficiency.


 
We believe that the candidate has proven experience as a Project Manager and holds the following qualifications: 

At least a bachelor degree in relevant field


Strong organizational and leadership skills.


Excellent communication and interpersonal abilities.


Proficient in project management tools and methodologies.


Ability to adapt to a rapidly changing environment, multiple priorities.


Self-motivated and able to demonstrate high levels of creativity, enjoy finding solutions to complex challenges.


Business focused mindset to identify opportunities for additional work throughout the project.


 
NorthX is supporting client at the technical forefront in development of advanced therapies, and we believe that experience from biotechnology or pharmaceutical industry is needed to be successful. Having experience from CMC, cell- and gene therapy and GMP is highly meriting.
 
Take the opportunity to make a difference within an exciting field, working with international clients and projects together with a team of amazing and competent colleagues.
For the right candidate we are offering a stimulating position with many opportunities for personal development. The preferred location for the position is at the NorthX Matfors site, but for the right candidate location at the Stockholm site with regular attendance in Matfors may be considered. Matfors is located less than 4h train or road journey north of Stockholm. The city and area offer a high quality of life through a rich variety of activities and the proximity to outdoor activities and striking countryside.
 
Join us in shaping the future! Your next adventure awaits.
 
For further information please contact:
 
Ola Tuvesson                                                 +46(0)70-10 93 585/[email protected]
Chief Technology Officer
                                           
Akademikerna, Lina Kejerhag                   [email protected]
Unionen, Jan Atterhagen                            [email protected] Visa mindre