Careers

Profil kvalitetschef och sakkunnig person / Head of Quality
and Qualified Person (Ref:CBM03)

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

Swedish:

Cobra Biologics i Matfors tillverkar produkter på uppdrag av andra företag och har för det tillstånd att tillverka läkemedel och prövningsläkemedel. Vi utför idag aseptisk fyllning och bioteknologisk tillverkning av proteiner.

Kvalitetsavdelningen består av två grupper som leds av varsin team leader QA och QC.

QA har det övergripande ansvaret för företagets kvalitetssäkringssystem och har en oberoende granskande funktion som medverkar till att leverera produkter som alltid uppfyller definierade krav. Gruppen består idag av 5 personer.

QC ansvarar för kemiska och mikrobiologiska analyser av produkter, vatten, tryckluft och kvävgas samt miljöprover från klassade lokaler. Gruppen består i dag av tre personer.

Arbetsuppgifter:

• Leda arbete och ansvara för att verksamheten inom kvalitetsavdelningen följer regulatoriska krav.
• Planera, prioritera och följa upp kvalitetsarbetet utifrån verksamhetens mål och leveransparametrar beskrivna i produktionsplan, underhållsplan, projektplan och beslutade CAPA.
• Utveckla och förvalta övergripande rutiner för kvalitetssäkring.
• Inspektera internt, leverantörer och kontraktstagare.
• Kvalitetssäkringsstöd i linje- och projektorganisationen.
• Certifiera satser enligt EU-GMP Annex 16.
• Bedöma avvikelser, ändringar, godkänna validering och styrande dokument.

Ansvar och befogenheter:

• Personalansvar; handledning, utvecklingssamtal lönesamtal och rehabiliteringsfrågor.
• Ekonomiansvar; etablera och följa upp avdelningens budget, attesträtt.
• Arbetsmiljöansvar.
• Bedöma om satser uppfyller kraven i interna dokument som t.ex. specifikationer och satsprotokoll och dokument som ligger till grund för marknadsföringstillstånd eller godkännande för klinisk prövning.
• Bedöma avvikelser och ändringar medavseende på produktkvalitet och analysresultatens tillförlitlighet.
• Som ägare av utrustning och system, godkänna kvalificeringar, validering och periodisk översyn.
• QA-godkänna kvalificeringar, validering och periodisk översyn.
• QA-godkänns styrande dokument som specifikationer och instruktioner.

Utbildning och erfarenhet:

• Naturvetenskaplig universitetsutbildning om minst 160 p/240 hp t.ex. apotekare, civilingenjör, biolog eller kemist.
• Behörig som sakkunnig person enligt LVFS 2004:7.
• Ledarerfarenhet från linjeorganisation eller projekt.
• Erfarenhet av kvalitetssäkringsarbete och mikrobiologiska frågeställningar inom aseptisk och bioteknologisk tillverkning.
• Erfarenhet att inspektera, egeninspektioner och leverantörsinspektioner.
• Goda kunskaper i myndighetskrav för läkemedel.
• Erfarenhet av kvalitetskontroll gärna från läkemedels- eller läkemedelsindustrin.
• Erfarenhet att arbeta med farmakopéer.
Personliga egenskaper
• God självkännedom.
• Analytisk och strukturerad med förmåga att prioritera och lösa problem.
• Självständig, flexibel, engagerad och ansvarstagande.
• God kommunikationsförmåga i tal och skrift, både på svenska och engelska.
• Positivt och stödjande förhållningssätt generellt och framförallt i samarbete med kunder och medarbetare.

English:

Cobra Biologics in Matfors is a contract manufacturer holding a manufacturing licences for medicinal products and investigational medicinal products and is engaged in aseptic fill finish and manufacturing of proteins with recombinant biotechnology.

We are currently looking to recruit a Head of Quality and Qualified Person to join our Quality department. The Quality Department includes two groups, QA and QC and is supervised by one Team leader for each. QA has the overall responsibility regarding quality assurance and has an independent and monitoring role contributing to products always complies to defined quality. The group consists of five Senior Quality Specialists.

QC is responsible for chemical and microbial testing and quality control on products, water and gases and samples from the environmental monitoring programme. The group consists of three persons.

The main duties will include:

• Organise and plan the work within the department and ensure it complies with regulatory requirements.
• Based on company goals, production and project plans plan, prioritise and follow up on quality performance.
• Develop and maintain overall procedures for quality assurance.
• Auditing, internally, suppliers and contract takers.
• Quality assurance support and advice.
• Batch certification according to EU-GMP Annex 16.
• Assess and decide on deviation, changes, validations and periodic reviews.
• Supervising, appraisals and rehabilitation of personnel.
• Develop and follow up on department budget.
• Safety, health and environmental issues within the department.

Qualifications and work experience:

• University degree of at least 160 p/240 hp in chemistry or biology for example pharmacist, civil engineering or similar.
• Comply with the requirement as Qualified Person according to LVFS 2004:7.
• Management experience achieved from project or line organization.
• Well experienced and knowledgeable of the regulatory requirement for manufacturing of medicinal products.
• Experienced in quality assurance achieved from the pharmaceutical industry.
• Experienced within quality assurance in aseptic, microbial and biotechnology issues.
• Audit experience.
• Knowledgeable in quality control and pharmacopoeias.

Personality:

• Good self awareness.
• Analytical and structured mind, capable of prioritising and solving problems.
• Independent, flexible, dedicated and responsible.
• Good oral and in writing communication skills in both Swedish and English.
• A positive and supportive approach in cooperation with clients and colleagues.


För ytterligare information/For further information please contact
Ann Stjärnkvist, Quality manager, Pharma: +46 70-2101062
Union representatives: Malin Lindroos, SACO: +46 60-641695
Jan Boberg, Unionen: +46-60-641630

Skriftlig ansökan med CV skall skickas till:/A written application should be sent to:
Karin Sundin, Site Administrator,
karin.sundin@cobrabio.com

Erfaren Kvalitetssäkrare / Senior Quality Specialist (Ref:CBM02)

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

Swedish:

Cobra Biologics i Matfors tillverkar produkter på uppdrag av andra företag och har för det tillstånd att tillverka läkemedel och prövningsläkemedel. Vi utför idag aseptisk fyllning och bioteknologisk tillverkning av proteiner.

QA, en av grupperna inom Kvalitetsavdelningen, har det övergripande ansvaret för företagets kvalitetssäkringssystem och har en oberoende granskande funktion som medverkar till att leverera produkter som alltid uppfyller definierade krav. Gruppen består idag av 5 personer. Tjänsten är tillsvidare.

Arbetsuppgifter:

• Utveckla och förvalta rutiner för kvalitetssäkring gällande produktberörande material samt förpacknings- och startmaterial, t.ex. rutiner för provtagning, specifikationer och värdering samt frisläppning.
• Utveckla och förvalta rutiner för bedömning av leverantörer av produktberörande material samt förpacknings- och startmaterial.
• Inspektera och bedöma leverantörer.
• Kvalitetssäkringsstöd för materialhantering på lager och förråd.
• Värdera och frisläppa förpacknings- och startmaterial.
• Bedöma avvikelser och ändringar.
• Godkänna kvalificeringar, validering och periodisk översyn.
• Godkänna styrande dokument som specifikationer och instruktioner.
• Stöd till säljare i offertarbetet.
• Leda eller delta i kundprojekt och interna förbättringsprojekt.

Utbildning och erfarenhet:

• Naturvetenskaplig universitetsutbildning om minst 120 p/180 hp t.ex. apotekare, civilingenjör, biolog, kemist eller liknande.
• Gedigen erfarenhet av kvalitetssäkringsarbete inom reglerad industri helst inom läkemedelsindustrin.
• Erfarenhet att inspektera; egeninspektioner och leverantörsinspektioner.
• Ledarerfarenhet från linjeorganisation eller projekt är meriterande.
• Goda kunskaper i myndighetskrav för läkemedel och regelverk som ISO eller god tillverkningssed.
• God kunskap om att arbeta med farmakopéer.

Personliga egenskaper:

• God självkännedom.
• Analytisk och strukturerad med förmåga att prioritera och lösa problem.
• Självständig, flexibel, engagerad och ansvarstagande.
• God kommunikationsförmåga i tal och skrift, både på svenska och engelska.
• Positivt och stödjande förhållningssätt generellt och framförallt i samarbete med kunder och medarbetare.

English:

Cobra Biologics in Matfors is a contract manufacturer holding a manufacturing licences for medicinal products and investigational medicinal products and is engaged in aseptic fill finish and manufacturing of proteins with recombinant biotechnology.

We are currently looking for a Senior Quality Specialist to join our Quality department. QA, one of the groups within the Quality Department, has the overall responsibility regarding quality assurance and has an independent and monitoring role contributing to products always complies to defined quality. The group consists of five Senior Quality Specialists and is managed by a Team leader.

The main duties will include:

• Develop and maintain procedures for quality assurance regarding packaging and starting material, e.g. procedures for sampling, specification and release.
• Develop and maintain procedures for assessment of suppliers of packaging and starting materials.
• Audit and assess suppliers.
• Quality assurance support for storage and warehousing.
• Assess and release of packaging and starting material.
• Assess deviations and changes.
• Approve qualification, validation and periodic review.
• Approve governing documents as specifications and instructions.
• Technical sales support.
• Participate in or manages customer projects and internal improvement projects.

Qualifications and work experience:

• University degree of at least 120 p/180 hp in chemistry for example pharmacist, civil engineering or similar.
• Long term experience of quality assurance in a regulated industry, preferably the pharmaceutical industry.
• Audit experience.
• Management experience achieved from project or line organisations.
• Knowledge of regulator standards in ISO or GMP.
• Knowledgeable in pharmacopoeias.

Personality:

• Good self awareness.
• Analytical and structured mind, capable of prioritising and solving problems.
• Independent, flexible, dedicated and responsible.
• Good oral and in writing communication skills in both Swedish and English.
• A positive and supportive approach in cooperation with clients and colleagues.

För ytterligare information/For further information please contact;
Helen Edlund: +46 60-641634
Union representatives: Malin Lindroos, SACO: +46 60-641695
Jan Boberg, Unionen: +46-60-641630

Skriftlig ansökan med CV skall skickas till:/A written application should be sent to:
Karin Sundin, Site Administrator,
karin.sundin@cobrabio.com.

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

We are currently looking to recruit a Senior Scientist, Quality Control, reporting to Analytical and Bioassay Service Delivery Manager. This role is a permanent position. The successful candidate will be required to work closely with the Quality Control Team Lead, project managers as well as with other functions within the organisation.

The main duties will include:

• Preparation of Study plans and Study reports.
• Report results for clients.
• Writing, review and approval of QC-documents.
• Coordination of QC-studies.
• Validation of Analytical methods and equipment.
• Representing the Analytical function in project teams.
• Generation of Standard Operating Procedures and Methods.
• Ensure the development of analytical HPLC methods (SEC, Affinity, IEX, RPC)
to meet customer requirements.

Qualifications:

• Education, PhD or equivalent, in Analytical science, or several years of    experience in relevant areas.
• General theoretical knowledge, experience and track record in analytical sciences in a regulated environment.
• Excellent understanding of laboratory work in a GMP regulated environment,
regulatory guidelines and pharmacopoeial procedures.
• Experience of instrument qualification, method development and validation.
• Very good theoretical and practical knowledge of Chromatographic techniques.
• Good theoretical and practical knowledge of Binding assays.
• Experience in protein chemistry is a merit.
• English and Swedish language skills.

The individual will be expected to interact at all levels of the organisation and should be able to demonstrate accuracy, responsibility and good communication skills. The position will be based at the Södertälje site.

Applications should be sent in writing stating the appropriate reference number with full CV to: anders.hagman@cobrabio.com

CLOSING DATE: 31 May 2013

Principal Scientist, Downstream Processing: Process and Analytics Development, Keele, UK (Ref:CBK03)

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

We are currently looking to recruit a Principal Scientist within the Operations Group at Keele, Staffordshire, UK. The successful candidate will be responsible for multiple product type downstream processing development.

The main duties will include:

• Responsibility for scientific process development delivery, working with technical leads and multidisciplinary teams to determine the optimal technical and scientific approach for assigned development programmes.
• Supporting the scoping and development of required analytics methods.
• Responsibility for technology transfer within the Cobra group or externally.
• Provision of recognized scientific technical expertise to the business.
• Supporting Commercial activities and working closely with Project Management 

In addition, this role will provide high level expert opinion on science practiced within the Company and will assist management to formulate scientific strategy to ensure that Cobra has a competitive advantage in process development. The successful applicant will also be expected to travel within the US and Europe.

The applicant must have extensive downstream development processing experience within the field of microbial protein and / or virus product experience; ideally with a PhD or MSc qualification. He/She will also be able to demonstrate:

• A broad knowledge of bio-processing with the ability to confidently interpret data, reach sound scientific conclusions, present, discuss and defend data / scientific direction both internally, to academic groups and clients.
• The ability to work independently with limited supervision, owning the scientific direction of their work as well as interact with academic groups.
• The ability to work in a multifunctional team. The ability to solve complex problems.
• The ability to demonstrate strong written and oral communication skills.
• He or she should have previously published work in peer reviewed scientific journals.

Applications should be sent in writing stating the appropriate reference number with full C.V. and current salary details to: Marie Cusworth, HR Administrator, Human Resources,  Cobra Biologics email; marie.cusworth@cobrabio.com. 

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

We are currently looking to recruit a Principal Scientist within the Operations Group at Keele, Staffordshire, UK. The successful candidate will be responsible for Analytical development, including method evaluation, specifically to support process development for product delivery in multiple products areas.

The main duties will include:

• Responsibility for scientific analytical development and evaluation, working with technical leads and multidisciplinary teams to determine the optimal technical and scientific approach for ensuring the efficient progression of assigned development programmes.
• The scoping and development of analytics methods; including high throughput assay development.
• Responsibility for technology transfer within the Cobra group or externally.
• Provision of recognized scientific technical expertise to the business.
• Supporting Commercial activities and working closely with Project Management.

In addition, this role will provide high level expert opinion on science practiced within the Company and will assist management to formulate scientific strategy to ensure that Cobra has a competitive advantage in process development. The successful applicant will also be expected to travel within the US and Europe.

The applicant must have extensive analytical development experience with specialist knowledge in microbial protein analysis; ideally with a PhD or MSc qualification. He/She will also be able to demonstrate:

• A broad knowledge of bio-processing and analytics application with the ability to confidently interpret data, reach sound scientific conclusions, present, discuss and defend data / scientific direction both internally, to academic groups and clients.
• The ability to work independently with limited supervision, owning the scientific direction of their work as well as interact with academic groups.
• The ability to work with and support a multifunctional team.
• The ability to solve complex problems.
• The ability to demonstrate strong written and oral communication skills.
• He or she should have previously published work in peer reviewed scientific journals.

Applications should be sent in writing stating the appropriate reference number with full C.V. and current salary details to: Marie Cusworth, HR Administrator, Human Resources, Cobra Biologics email; marie.cusworth@cobrabio.com

Principal Scientist, Microbial Products: Process and Analytics Development, Keele, UK (Ref:CBK02)

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

We are currently looking to recruit a Principal Scientist within the Operations Group at Keele, Staffordshire, UK. The successful candidate will be responsible for microbial product upstream development.
The main duties will include:

• Responsibility for scientific process development delivery, working with technical leads and multidisciplinary teams to determine the optimal technical and scientific approach for assigned development programmes.
• Supporting the scoping and development of required analytics methods.
• Responsibility for technology transfer within the Cobra group or externally.
• Provision of recognized scientific technical expertise to the business.
• Supporting Commercial activities and working closely with Project Management. 

In addition, this role will provide high level expert opinion on science practiced within the Company and will assist management to formulate scientific strategy to ensure that Cobra has a competitive advantage in process development. The successful applicant will also be expected to travel within the US and Europe.

The applicant must have extensive fermentation development experience within the Microbial field; ideally with a PhD or MSc qualification. He/She will also be able to demonstrate:

• A broad knowledge of bio-processing with the ability to confidently interpret data, reach sound scientific conclusions, present, discuss and defend data / scientific direction both internally, to academic groups and clients.
• The ability to work independently with limited supervision, owning the scientific direction of their work as well as interact with academic groups.
• The ability to work in a multifunctional team.
• The ability to solve complex problems.
• The ability to demonstrate strong written and oral communication skills.
• He or she should have previously published work in peer reviewed scientific journals.

Applications should be sent in writing stating the appropriate reference number with full C.V. and current salary details to: Marie Cusworth, HR Administrator, Human Resources, Cobra Biologics email; marie.cusworth@cobrabio.com.