Chemical Api Subject Matter Expert

vor 1 Woche

Basel, Schweiz PM Group Vollzeit

:
**The Role**

We have an exciting opportunity for a Chemical API SME to join our team.The role is to work as a Subject Matter Expert providing technical leadership on Chemical API. As a member of the global SME Group the person employed can be located in one of the PM Group offices in Europe. We work a hybrid work model while the role will require travel to project meetings/workshops as required.

**Who we are**

PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.
:

- To be a technology leader in nominated area(s) which includes:

- Being aware of upcoming technology changes, developments, innovations
- Writing papers, presenting at industry conferences
- Being involved with industry bodies such as the ISPE, ICHEME (or equivalents)
- Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
- To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID’s and layout philosophies, early phase project reports
- To technically assist project teams as required.
- To undertake Peer Reviews of work performed by other companies.
- To perform in appropriate SMEs reviews of client sites.
- To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company
- To participate and/or chair technical design reviews as appropriate.
- To support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
- To actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities.
- To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
- To be 80% bookable.
- Travel to Project meetings /workshops as required
- Other special projects as assigned

**Specific Knowledge Areas to be covered by the Role include**
- Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs
- Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas based reactions. Filtration, Centrifugation, Drying, Milling and blending
- Principles of facility layout such as:

- Layout adjacencies
- Stack-up
- Segregation approaches
- Aspects related to technologies such as:

- Batch, semi-continuous and continuous processing
- Solvent and reagent handling
- Materials handling
- Cleaning technologies
- Solid, liquid and gaseous waste handling and treatment
- Automation
- Utility generation and distribution
- Aspects related to project delivery such as:

- Basis of design
- Safety framework including relief systems, ATEX, and containment
- Simulation tools
- Tech Transfer
- Bid analysis
- Supplier interfacing
- Commissioning and Qualification
- Aspects related to facility operations such as:

- Operating philosophies
- GMP Regulatory framework

:

- Bachelor’s degree; Masters preferred
- 15 years + of appropriate experience around Chemical API facilities and operations
- A history of wider industry engagement with institutions such as the ICHEME (or equivalent) and an awareness of key industry technology initiatives and direction
- Excellent knowledge relating to area of speciality
- Direct experience working within capital projects and delivery related to process facility design and construction
- Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines

**Why PM Group?**

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our **Corporate Responsibility and Heath, Safety & Well-being Report 2022.**

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

  • Logistics Subject Matter Expert

    vor 2 Wochen

    Basel, Schweiz PM Group Vollzeit

    : **The Role** The role is to work as a Subject Matter Expert providing technical leadership on Logistics. As a member of the global SME Group the person employed can be located in one of the PM Group offices in US, Europe or Asia. We work a hybrid work model while the role will require travel to project meetings/workshops as required. **Who we are** PM...

  • Analytical Subject Matter Expert

    Vor 6 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Key Responsibilities/Scope of the Job** **Shared responsibilities**: - Act as analytical lead when appropriate for managing analytical projects under his/her responsibility - Cross functional interaction/collaboration within Sobi organization. - Interaction/collaboration with CDMOs/CLOs as required by the projects. - Act as a technical expert for...

  • Analytical Subject Matter Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Key Responsibilities/Scope of the JobShared responsibilities: Act as analytical lead when appropriate for managing analytical projects under his/her responsibility Cross functional interaction/collaboration within Sobi organization. Interaction/collaboration with CDMOs/CLOs as required by the projects. Act as a technical expert for designing analytical...

  • Fill Finish Subject Matter Expert

    vor 1 Woche

    Basel, Schweiz PM Group Vollzeit

    : **The Role** The role is to work as a Subject Matter Expert providing technical leadership on Fill Finish. As a member of the global SME Group the person employed can be located in one of the PM Group offices in US, Europe or Asia We work a hybrid work model while the role will require travel to project meetings/workshops as required. **Who we are** PM...

  • Third Party QA Manager Api

    vor 1 Woche

    Basel, Schweiz Elanco Vollzeit

    Education : EQUIVALENTEXPERIENCE **As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance...

  • Third Party QA Manager Api

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Elanco Vollzeit

    Education :EQUIVALENTEXPERIENCEAs a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our...

  • Chemical Laboratory Assistant

    vor 3 Wochen

    Basel, Schweiz Adecco Vollzeit

    We are opening a great job opportunity for a Chemical Laboratory Assistant (M/F/d) 100% for one of our well-known Medical Industry clients in the Zurich region. **Chemical Laboratory Assistant (M/F/d) 100%**: **Your challenges** The successful applicant for the job as a Chemical Laboratory Assistant (M/F/d) 100% will be responsible for: - Carry out...

  • Quality Systems Expert

    vor 1 Woche

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **About** the **role**: The Quality System Expert is responsible for supporting the Quality Systems group from an Administrator/Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP. The Quality Systems Expert insures that new or modified Quality Systems (Deviation, CAPA, Change control, Complaint,...

  • Quality Systems Expert

    vor 1 Woche

    Basel, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a...

  • Quality Systems Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • Product Quality Expert

    vor 4 Wochen

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products. The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External...

  • Product Quality Expert

    vor 4 Wochen

    Basel, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a...

  • Experte-manufacturing Visuelle Kontrolle

    vor 1 Woche

    Basel, Schweiz ITech Consult Vollzeit

    **Experte-Manufacturing Visuelle Kontrolle (m/w/d)** **Projekt**: Für unseren Kunden, ein grosses Pharmaunternehmen mit Sitz in Basel suchen wir einen **Experte-Manufacturing Visuelle Kontrolle** **Hintergrund**: Pharma Technical Development Europe Biologics (PTDE) bringt bahnbrechende Therapien aus der klinischen Phase auf den Markt, um jeden Patienten...

  • Product Quality Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    About the role:As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products.The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External inspections...

  • Experte-manufacturing Visuelle Kontrolle

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz ITech Consult Vollzeit

    **Experte-Manufacturing Visuelle Kontrolle (m/w/d)****Projekt**:Für unseren Kunden, ein grosses Pharmaunternehmen mit Sitz in Basel suchen wir einen **Experte-Manufacturing Visuelle Kontrolle****Hintergrund**:Pharma Technical Development Europe Biologics (PTDE) bringt bahnbrechende Therapien aus der klinischen Phase auf den Markt, um jeden Patienten zu...

  • Qualification Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    D-ploy is a company specializing in IT and Engineering Solutions, operating across the EMEA region, from Switzerland, Germany, Czech Republic, Austria, UK, to the USA.We take pride in providing cutting-edge services to top-tier clients, fostering strong relationships within the IT community to enhance our customer's IT efficiency and contribute to...

  • Archivspezialist 100% (M/F/d)

    vor 3 Wochen

    Basel, Schweiz Julius Baer Vollzeit

    At Julius Baer, we celebrate and value the individual qualities you bring, enabling you to be impactful, to be entrepreneurial, to be empowered, and to create value beyond wealth. Let’s shape the future of wealth management together. **YOUR CHALLENGE**: - Bankweite Koordination und Stakeholder-Management für alle Archiv - und Datenspeicherthemen -...

  • Experte-manufacturing Visuelle Kontrolle Für F

    vor 2 Monaten

    Basel, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH ist ein national in der Schweiz agierendes Unternehmen, welches dank langjähriger und erfolgreicher Erfahrung über eine hohe Kompetenz im Personaldienstleistungsbereich verfügt. Konzentration der Vermittlertätigkeiten auf die Kernbereiche Industrie, Technik, Büro/Administration, Engineering, Pharma und Informatik. Die We...

  • Experte-manufacturing Visuelle Kontrolle Für F

    Vor 2 Tagen

    Basel, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH ist ein national in der Schweiz agierendes Unternehmen, welches dank langjähriger und erfolgreicher Erfahrung über eine hohe Kompetenz im Personaldienstleistungsbereich verfügt. Konzentration der Vermittlertätigkeiten auf die Kernbereiche Industrie, Technik, Büro/Administration, Engineering, Pharma und Informatik. Die We...

  • Experte visuelle Kontrolle im Manufacturing

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Flexsis SA Vollzeit

    Unser Beruf und unsere Leidenschaft «HR-Management» .Flexsis AG ist ein eigenständiges Unternehmen der Interiman Group SA mit über 100 Mitarbeitenden, die an 21 Standorten in der Deutschschweiz ein komplettes Programm von Dienstleistungen im Bereich Human Resources anbieten.Aufgrund stetigem Wachstum und zur Verstärkung des Teams, suchen wir für...