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My Client a Leading Pharmaceutical Company based in Belgium requires an IT Infrastructure & Industrial coordinator - Pharma.

This mission is a full-time mission, for a minimum of 6 months - extendable, with prime location at Braine l'Alleud (Belgium) with partial remote working opportunity (up to 1 day/week) - up to re-evaluation according sanitary situation.

Starting date: ASAP

Introduction:

• IT TSCC Industrial Framework

In today's world, and even more with digital transformation and Manufacturing 4.0 ambition, technologies (digital product, smart devices, IoT, .) are everywhere and part of complex and interconnected landscape opened to external threats. This requires cyber vigilance where IT has the mandate to take control on all technologies including industrial ones and ensure compliance with quality and security standards.

At my client they developed an IT TSSC Framework, made of:

• a set of standard rules (service definition, requirements and standards (specification, SOP) to which any industrial technology will have to comply)
• an IT Industrial digital governance

The IT TSCC Industrial Coordinator is the guardian of this framework and will have to apply it within any industrial initiative such as the building of a modern biological production factory: Inflexio (see below).

• TSCC

Trustworthiness

Being transparent (to the extent possible) about how an application functions, how the user's data is being used and for what purpose and how we meet which regulatory requirements. Being deliberate about ethical considerations of an application.

Security

Ensuring the right safeguards are in place, including the processes to deal with a security incident.

Safety

Ensuring an application does no harm in case of a defect or a breach.

Compliance

Meeting regulatory requirements relevant to the use case of an application including geographical considerations.

• Inflexio

As part of the Accelerate Strategy, my client has launched InfleXio project which aims to design, build, commission and validate on its Braine l'Alleud site a new multi-product manufacturing facility to produce Mab-type bulk Drug Substances under cGMP conditions with high operational efficiency.

This new manufacturing plant will have to be integrated into the business IT landscape/ecosystem considering digital transformation ambition, quality standards and operability. For scope introduction please refer to the attached picture in related section.

In the context of Inflexio the IT TSSC Industrial Coordinator will be in charge of:

1. 1. Own, derive and enhance the IT TSSC Industrial Framework for Inflexio by:
   1. Customizing it whenever it is needed
   2. Defining accelerators (templates, deliverables) as much as needed
   3. Tailor the dedicated governance process to the specificities of the project
   4. Assist with the integration of the processes into the digital platforms in use for IT Digital governance
   5. Execute the IT TSCC Industrial Framework in the various phases (technology acquisition and design, implementation ) by:
      1. Assessing each and every work package building, utilities, process, .) managed by the Inflexio project team to evaluate if those contain technologies and which IT services (network, hosting, ) should be provisioned, hence which standard apply.
      2. Publishing the IT TSSC Industrial standard (requirements) to binding partners and guide as well as engage those partners to provide answers against those requirements.
      3. Collecting and reviewing the answers provided by the selected suppliers and provide the next level of specifications.
      4. Coordinating, together with the specific IT Subject Matter Expert (service owner), a formal digital governance review aiming to validate the answers from the supplier to the specific requirements and standards up to their acceptance or managing non-conformity in a risk-based approach.
      5. In partnership with procurement and legal, ensuring that supplier contracts reflect instruction resulting from the compliance or exception to the specifics requirement and standards.
      6. Documenting the specification of the solution in regards of those requirements and standards into a Design Specification as basis for further qualification and testing process.

Expected skills & experience

Education - bachelor or master's degree (preferably in, Computer Science, biosciences, Engineering )

Language - English, French

IT technical skills - Proven experience in IT & OT( 5y)

• Broad knowledge of IT & OT infrastructure services used in pharmaceutical/manufacturing plant
• Broad knowledge of IT Security in the context of Industrial technologies
• Broad knowledge of Industrial, Engineering, automation practices and technologies and their integration and management as part of IT Landscape and standards.
• Exposure to IT and OT change coordination in a complex industrial landscape

IT Management in Compliance and Security

• Minimum 5 years' experience and successful track records (at least 2 end-to-end delivery) in IT Compliance, quality and security management in all its aspects: IT infrastructure, IT application with strong focus on Industrial/manufacturing in pharmaceutical, regulated environment.

• Experience in Third-Party provider assessments

Business Knowledge

• Strong understanding of IT infrastructure and application landscape within pharma and biopharma industrial and security orientation
• Experiences in regulated process focused on manufacturing (GxP environment)
• Conceptual thinking, methodic and rigorous
• Strong in change management, stakeholder engagement, supplier relationship and communication skills
• Ability to work alone, in full autonomy and analytically in a problem-solving environment
• Negotiation skills
• Be accountable and result oriented, striving for Operational Excellence, total quality and best practices
• Have an open, positive attitude, be a team player across different teams and different levels of the organization
• Be agile by being able to perform at operational and tactical, strategic level
• Be ready to challenge and be challenged

Expected capabilities

• Conceptual thinking, methodic and rigorous
• Strong in change management, stakeholder engagement, supplier relationship and communication skills
• Ability to work alone, in full autonomy and analytically in a problem-solving environment
• Negotiation skills
• Be accountable and result oriented, striving for Operational Excellence, total quality and best practices
• Have an open, positive attitude, be a team player across different teams and different levels of the organization
• Be agile by being able to perform at operational and tactical, strategic level
• Be ready to challenge and be challenged

Please Quote Ref - JSLES1034

Regulatory Affairs CMC Associate Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

• University degree in Chemistry, Pharmacy or a similar field
• Regulatory experience preferred and experience in drug biopharmaceuticals
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
• Experience of the drug development process desirable paired with the ability to critically evaluate data from a broad range of scientific disciplines
• Knowledge of regulations, guidelines for NCEs and product life cycle maintenance desirable
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
• Languages: English, fluent in written and spoken, German is advantageous

Your tasks:

• Authoring high quality CMC documentation for HA submission and applying agreed CMC global regulatory strategies assuring technical congruency and regulatory compliance

• Preparing CMC responses to health authority questions during development, registration and product life cycle
• Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Recognizing content, quality and timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
• Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
• Establishing and maintaining sound working relationships with partners and customers as well as assuming activities in support of the general department such as DRAGON support, annual and product renewal writing

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.

Going the Extra Mile.

As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.

Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

New to Switzerland? In case of a successful placement, we support you with:

• All administrative questions
• Finding an apartment
• Health- and social insurance
• Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

New opportunity has been created for a Junior Regulatory Affairs Specialist CMC in the global pharmaceutical company with HQ based in Basel. The role will focus on all stages of regulatory affairs submission in biological products.

Major Activities

1. Authoring CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project life cycle.
2. Prepare CMC responses to health authority questions during development, registration and product life cycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
6. Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Requirements:

Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
1. Regulatory experience in drug/biopharmaceuticals
2. Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
3. Knowledge and experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
4. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
5. Effective planning, organizational and interpersonal skills.

This is a temporary contract role for 12 months with a great chance for extension.
Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

#15584 | 10 month contract | Switzerland

James Carrera at Umbilical has partnered with a Global Pharmaceutical client to source an experienced Technical Writer to support the update of existing life cycle documentation for the infrastructure and support teams in accordance with client SOP's.

Accountable for:

Independently lead investigations & interview sessions with technical experts - to gather inputs for the documentation;

• Update existing and create new Lifecycle documentation in close collaboration with Infrastructure Support teams, key documents to be created/updated
• SOM (Service Operation Manual)
• SOP
• Working Instructions

Qualifications:

Educated to degree level you will be an experienced Technical Writer with demonstrated experience within a highly regulated GxP environment, as well as;

• Writing technical & process documentation
• IT processes - at least generally ITIL
• Access management; Windows focuses, AD and ideally; PAM, APS, etc
• Technical IT experience and overview, in particular; infrastructure & its hosting - Windows, Backup, Nutanix/ESX/Virtualization, Storages)

For a confidential discussion, contact James Carrera at Umbilical

Reference ID: 15584

Contract length: 10 months

Job Types: Full-time, Contrac

Senior Investigator vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

• 10 years of experience in drug discovery, development or a relevant environment such as Clinical Pharmacology, Drug Metabolism or Pharmacokinetics
• PhD degree in Drug Metabolism, Pharmacokinetics or a related biologic background
• Extensive and in-depth knowledge of drug metabolism and pharmacokinetics
• Know-How of working in cross functional project teams and awareness of recent progress in drug development sciences
• Knowledge of regulatory requirements and experience in dealing with regulatory authorities
• Expertise in relevant laboratory tools and procedures as well as extensive library research skills
• Good understanding of management and training principles paired with a sound and robust list of scientific and external publications
• Languages: English, fluent in written and spoken

Your tasks:

• Participating in PKs sub-team to define strategies for compound progression and development

• Managing study timelines, objectives and budgets, ensuring accuracy of project progress in company tracking tools
• Accounting the timely and effective communication of data, strategy, results and impact to various project teams
• Ensuring alignment of plans and strategies with sub-teams, project teams, managers and leadership teams
• Analyzing and interpreting PK, TK, PD and IG data generated during discovery, early and full development as well as presenting results and implications to the program
• Identifying potential project hurdles, providing solutions and implementing contingency plans
• Authoring and preparing key pre-clinical and clinical study protocols, study reports, modelling reports and investigator reports as well as leading cross-departmental teams and work streams a

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.

Going the Extra Mile.

As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.

Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

New to Switzerland? In case of a successful placement, we support you with:

• All administrative questions
• Finding an apartment
• Health- and social insurance
• Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

For our client in Oberdorf we are searching for Material Engineer for 14 months project

Job Title: Material Engineer
Duration: 19/10/2020 to 31/12/2021

Location: Oberdorf

Workload: 100%

We are looking for a Material Engineer

Ideally we need a resource with experience especially with metallography and structural analysis of metals. The person will support a service unit which supports all the different business lines with material related issues (development, analysis of non-conformity and failures in the production phase) as well as with investigations with external complaints.

Tasks
. Planning, coordination and implementation of material-related investigations and analyzes
. Influence on the required material and product quality, especially in the area of raw materials and manufacturing processes.
. Commissioning, coordination and interpretation of investigations in internal and external laboratories in the field of material and defect analysis and preparation of reports and rationales
. Cooperation with other sites regarding investigations for development departments and production
. Technical support for other departments in material selection and processing
. Creation of new work instructions and material specifications in cooperation with the USA Team

Profile
. Master's (FH or university) with a focus on materials science/materials science or materials technician/metallograph with corresponding experience and further training
. At least 5 years experience in industry or laboratory with a focus metallic materials/surface technology (alternatively young graduate to be trained and formed)
. Work experience in medical technology or in error analysis is an advantage
. Enjoy solving and documenting complex issues within a wide range of materials
. German and English: fluent written and spoken
. Organizational skills, initiative, communication skills
. Willingness to take responsibility, reliability, customer orientation
. Exact working method

My client is a leading global solutions provider delivering value-added services into end-users.

Their client is a widely respected pharmaceuticals business urgently seeking a functional business analyst with experience of Veeva CRM used in pharma settings.

Experience required:

• 5 years plus experience in Veeva CRM
• Solid experience in Salesforce product implementation
• At least one completed full-project life cycle work within pharma or FMCG
• Experience as a functional business analyst
• Experience in life science domain with project/release/change management
• Salesforce certified in Sales Cloud, Service Cloud, Health Cloud, Marketing Cloud
• Track record of successful working with programme and project managers
• Ability to form value propositions

Please forward your CV for immediate consideration.

Senior Requirements Engineer/Systems Engineer

Role:
For our client in the Pharma industry based in Rotkreuz, we are looking for a Senior Requirements Engineer/Systems Engineer.

Within CPS R&D Hematology and Coagulation, the Product Definition Team (PDT) for Hematology ensures in close collaboration with our business functions the comprehensive understanding of customer needs in this business segment and its translation into requirements for our future Hematology platform. For this PDT we are looking for a Requirements Engineer with a strong Systems Engineering acumen.

Areas of responsibility:
- Leading the Requirements Engineering (elicitation, analysis, elaboration, validation) for dedicated features and functions within a complex project
- Creating an understanding of customer need and rationale for the product in close collaboration with business functions
- Taking leadership to drive cross-functional alignment, team decisions around the elaboration of requirements and fit of technical solutions to create customer value
- Developing Operational Concepts of the system and the interface of a connected system environment in the domain of Hematology Systems including information flow
- Driving assessment of technical and software requirements changes with special focus on suitability to overall system capabilities
- Creation of respective Design and Change Control deliverables
- Support of the project scope process and providing clarity of required features and functions to the respective stakeholders
- Using efficiently Application Management Tools and continuously support improving Requirements Engineering practices.

Professional and technical requirements:
- B. SC/M. SC in Engineering or Life Science
- 5 - 7 years of working experience in multiple complex system projects over the whole development process, including product life cycle
- Certification in CPRE/IREB and/or CCBA/IIBA, ASEP (INCOSE) or equivalent comprehensive training in systems engineering
- Analytical thinking with the ability to see the big picture as well as the details
- Curious to understand complex structures and behaviors
- Good communication skills, patience, and tenacity
- Ability to lead, follow-up and work well in large and multidiscipline teams
- Applied knowledge of requirements engineering approaches and tools

Reference no: 919705 AD
Role: Senior Requirements Engineer/Systems Engineer
Industry: Pharmaceutical industry
Workload: 100%
Location: Rotkreuz, Switzerland
Start date: 16.10.2020
Latest start date: 02.11.2020
Duration: until 30.03.2021, with possible extension

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialized in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your Search for a new project and being employed.

Our client, a Global Swiss Pharmaceutical company based in Basel, who is currently on an exciting growth curve are seeking Senior Scientists on an urgent basis for an initial 12 months with a strong likelihood for extension for their Basel site.

Key responsibilities will include:

• Planning, interpreting and reporting results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
• Performing raw data checks for externalized activities
  Support writing & reviewing analytical documents (eg Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and aligning the corresponding activities within a global project team.
• Managing interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary.
• Proactively identifying scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
• Working according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal guidelines.

The successful incumbent will possess:

• Minimum: Master in analytical chemistry, equivalent or Jr. PhD
• At least 4 years' experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
• Profound expertise in analytical raw data documentation
• Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
• Advanced knowledge of laboratory and/or technical tools (eg HPLC, LC-MS, Quality management systems, statistical evaluation tools ...) .
• Good knowledge of commonly used software and computer tools.
• Good scientific/technical writing skills.
• Fluent in English (oral and writing), German a plus

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

For our Pharma Client in Basel, we are currently looking for a

Systems Validation Specialist

Location: Basel area

Contract type: temporary contract

Start/Ende: 16.10.2020 - 9 months contract

Workload: 100%

Background:

Are you a strong Business Systems Analyst with demonstrated experience on multiple projects who is looking for a creative, challenging and fun work environment and an opportunity to expand your skills?

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare, we've only scratched the surface. Our Client is accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare.

Your primary accountability is to provide quality leadership. By being deeply engaged with the business partners, you will develop a strong understanding of safety, clinical and medical data; you are driving design, creation, and adoption of novel validation strategies, ensuring data integrity and privacy to teams across the product development life cycle. As a BSA, you will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.

Tasks & Responsibilities:

- Concurrently manage multiple projects of diverse scope across functional areas
- Manage and deliver projects using agile and waterfall methodologies
- Able to articulate and facilitate the understanding of a system's intended use and it's compliance risk profile.
- Risk-based identification and classification of GxP systems
- Guide software project and product teams in understanding their role in establishing and maintaining the compliance of critical systems.
- Drive simplification and transparency across the organization
- Manage compliance documentation processes including, but not limited to, System Risk Assessments (SRA) and Data Classification Reports (DCRs)
- Leverage the technical expertise of the internal teams and external technology providers and vendors to deeply understand the risk.
- Manage vendor risk
- Characterize for compliance purposes as-built and vendor provided business solutions that may involve automated systems and/or modifications to business processes.
- Engage with Procurement on acquisitions and assess compliance against internal expectation and SOPs'
- Assess outsourced vendors and clinical suppliers.
- Be a trusted partner for the Global Privacy Office, IT Security, and Business Qualityteams
- Maintain an expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11.

Be accountable for documentation, which may include, but is not limited to:
- System Risk Assessments
- Data Classification Reports
- User Requirements
- Validation Plans
- Validation Reports
- Validation Registries
- Requirements Traceability Matrices
- Test Plans
- Test Reports
- Functional and/or technical specifications
- Data and process flow diagrams
- Training documentation and/or work instructions
- Other Computer System Validation documents and related systems
- Drive resolution of business or systems issues.

Must Haves:

- BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable
- At least 10 years of related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD, Data Privacy
- 3 years in a technology role IT or Data
- Program or IT Project management experience
- Expert knowledge of Software Development Life Cycle methodologies, inclusive of Agile.
- Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact(*)
- Strong English and German communication skills (nice to have) -- ability to communicate complex information, issues, and potential solutions at an executive level