Associate Director, Technical Project Leader Drug

vor 9 Stunden


Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**About Idorsia Pharmaceuticals Ltd**

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an **Associate Director, Technical Project Leader Drug Product **to join our late-stage development and commercial oral dosage forms and lead the drug product development of various oral products entering our clinical pipeline

**Responsibilities**:
The Associate director, Technical Project Leader Drug Product will lead the technical development of several oral solid dosage form products, from late phase development activities (Phase 3) up to commercialization, including formulation development and production scale up with external partners
- Lead and manage development, analysis and production of solid dosage forms, including clinical and market forms
- Ensure sufficient and timely supplies for development projects based on input from the Global Supply Chain, CMC, Project and/or Life Cycle management functions
- Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
- Lead the technical drug product development activities: plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from development (late stage - Phase 3) up to commercial supplies
- Support the development, communication and execution of the overall CMC strategy
- Ensure compliance with regulatory guidelines
- Pharmacist or Equivalent with PhD Minimum of 10 years job relevant working experience in the pharmaceutical industry, especially with late-stage development (Phase 3) and / or Registration/process Validation/launch phase
- Minimum of 5 years of leading of an interdisciplinary drug product team
- Scientific expertise in small molecule formulation development
- Scientific expertise in oral solid dosage forms
- Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines
- Profound knowledge in QbD, DOE and QRM
- Ability to negotiate, plan, and coordinate technical development and manufacturing activities
- Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics
- Excellent English knowledge (oral and written)

**What Idorsia offers**
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous social benefits

**Work Location**: Basel Area - Allschwil

**Country**: Switzerland

**Business Area**: Global Pharmaceutical Development and Quality Assurance

**Schedule**: Fulltime

**Job Type**: Permanent

**Job ID**: 3476



  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project & Product Lead - Drug Product (Parenteral/Combination Product) - 5759 ADA** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a **Technical Project & Product Lead - Drug...


  • Basel, Schweiz Novartis Vollzeit

    389788BR **Drug Product Project Leader (Oligonucleotides) (M/F/d)**: Switzerland **About the role** Location: Basel, Switzerland Join us in a cutting-edge role as a Drug Product Project Leader (DPPL) for Oligonucleotides, where you will have the opportunity to work on innovative parenteral formulations and contribute to the development of patient-centric...


  • Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are currently looking for an Associate Director CMC of Technical Development to join a brilliant biotech organisation on a permanent basis located in Basel. Our client is focused on producing the next generation of multifunctional accuracy immunotherapies. Please note that to be considered for this role you must have the right to work in this...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Life-Changing Opportunities:Lonza's products and services have a positive impact on millions of people worldwide. As our Senior Technology Transfer Lead, you will be part of a group that enables its customers to meet some of the greatest challenges in patient treatment. By applying for this position, you will become part of a successful Contract Development...


  • Basel, Schweiz Novartis Vollzeit

    100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: The Associate Director of Global Logistics Project Resilience is a newly created position responsible to lead the Global Logistics Workstream in Moderna’s Resilience project to establish 3 manufacturing sites in Australia, Canada and UK. He/She must ensure that the logistics set-up is an accurate reflection of the business requirements and in...


  • Basel, Schweiz Ridgeline Discovery GmbH Vollzeit

    **Ridgeline Discovery is looking for an (Associate) Director, Computer Aided Drug Design**. **Ridgeline Discovery** is a Versant Ventures Discovery Engine located in Basel, Switzerland. Founded in 2017 to create and operate Versant-financed innovative biotech companies it has an international team of more than 30 highly experienced drug discovery...


  • Basel, Schweiz Drug Information Association Inc Vollzeit

    DIA is a global healthcare association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers, and thought leaders in a neutral environment on the issues of today and the possibilities of tomorrow. We envision a world where powerful health interventions and health-management tools are rapidly discovered,...


  • Basel, Schweiz Hengrui Europe Therapeutics AG Vollzeit

    **Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development **About Hengrui**: The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative...


  • Basel, Schweiz Novartis Farmacéutica Vollzeit

    Drug Product Project Leader – Oral Dosage Forms (80-100%)Job ID REQ-10032015SummaryLocation: Basel, SwitzerlandRole Purpose:Novartis holds a rich development portfolio of small molecules ready to develop into innovative, patient centric, oral dosage forms. As a Drug Product Project Leader (DPPL) working on oral dosage forms, you will lead and manage...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project Lead - Pharma Manufacturing (DP) - 5270 ADA** Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a **Technical Project Lead with expertise in Pharma Manufacturing** (Drug Product). You will establish Manufacturing Science and Technology (**MSAT**)...


  • Basel, Schweiz Luzsana Biotechnology (Part of Hengrui) Vollzeit

    **Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development Luzsana Biotechnology (Luzsana) is a global, purpose-driven innovative medicines company with the mission to deliver medicines...


  • Basel, Schweiz BioTalent Vollzeit

    BioTalent is collaborating with an Innovative Swiss based BioTech company in the rare disease field. We are looking to appoint an Associate Medical Director of Drug Safety in a full time capacity. This is a rare opportunity for an experienced individual to join a forward thinking and expanding company. **Offer**: - Permanent, full time position -...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    About RocheRoche is a global leader in healthcare, dedicated to improving lives through innovative medical treatments and technologies. With over 100,000 employees across 100 countries, we are united by our mission to make a difference in patients' lives.A Dynamic Work EnvironmentWe foster a dynamic, inclusive work environment that encourages full...


  • Basel, Schweiz PM Group Vollzeit

    **Technical Project Lead - Mechanical**: - Contract - Onsite - Basel, Switzerland - Engineering - 7361 **Overview - On behalf of a Client in Switzerland, PM Group are looking to hire a Lead Project Engineer; (Technical Project Lead - Mechanical) **Responsibilities** - Study & understand the scope of the project and the applicable standards - Proactively...


  • Basel, Schweiz ITech Consult Vollzeit

    **Analytical Project Leader Scientist (M/F/d)** **Analytical Project Leader Scientist (M/F/d) - pharmaceutical / analytical development / PCR / GMP / IND (Investigational New Drug) and NDA (New Drug Application) submissions/ English/ German** **Project**: For our customer a big pharmaceutical company in Basel we are looking Analytical Project Leader...


  • Basel, Schweiz Drug Information Association Inc Vollzeit

    DIA is a global healthcare association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers, and thought leaders in a neutral environment on the issues of today and the possibilities of tomorrow. We envision a world where powerful health interventions and health-management tools are rapidly discovered,...


  • Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Cmc Lead

    vor 9 Stunden


    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a CMC Lead - Drug Substance for a pharmaceutical organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Europe with occasional visits to Basel. **Responsibilities**: - Accountable for drug substance CMC development actions from late stage to product licensure. - Author/evaluate and...


  • Basel, Schweiz Lonza Vollzeit

    Switzerland, Basel- Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas,...