Cmc Lead Drug Substances

vor 4 Wochen

Basel, Schweiz Sobi Vollzeit

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**

**CMC Lead Drug Substances**:
**Role & Function**

**Key Responsibilities**
- Responsible for drug substance CMC development activities from late stage to product licensure.- Resource planning, project timelines and budget.- Staff management.- Writing/reviewing and approval of technical protocols and reports.- Writing/reviewing of CMC sections (module 3) of regulatory submissions and responses to any agency questions.- Provide input to project feasibility and suggest changes to ensure successful completion of assigned projects.- Interface with project governance committees (internal and external) as required- Provide scientific leadership and direction to the CMC Development team in order to advance the company’s platforms as well as the current and future product portfolio.- Ensure all activities are carried out to company’s global quality and safety standards.**Qualifications**
- PhD/Master in Biotechnology or equivalent.- 15 years plus experience in late stage development and GMP manufacturing of pharmaceutical products.- Familiarity with regulatory guidance’s pertaining to the Chemistry, Manufacturing and Control of manufacture pharmaceutical products.- Experience in project management of complex technical projects involving several internal and external stakeholders.- Experience in working with C(D)MO’s and CLO’s.- Excellent communication, negotiation and conflict management skills.- Ability to think strategically, create innovative strategies, drive changes, manage ambiguity and able to anticipate future trends and consequences.- Ability to work cross-functionally in a matrix environment.- Excellent leadership skills with the ability to motivate, inspire and manage a team.- Excellent verbal and written communication skills in English; French, Swedish, German is a plus.**Personal attributes**:

- Excellent understanding of development processes and challenges - Problem solving, creative, flexible with regards to evolving priorities - Organized, detail oriented and structured working style - Deliver results in a complex business network - Foster collaboration and teamwork and engage internal and external expertise as needed - Perceive change as an opportunity for improvement and successfully manage ambiguity In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**
The position will be based in Basel, Switzerland.

**Reporting to**
Head of CMC Development

**Recruitment contact & how to apply**

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

  • Cmc Lead Drug Substances

    vor 2 Monaten

    Basel, Schweiz Hobson Prior Vollzeit

    **Salary**: CHF150000 - CHF165000 per annum**Job type**: Permanent **Location**: Basel, Switzerland **Function**: Technical Operations, Quality Control, Chemist **Posted**:05/05/2023 **Ref**: BBBH22209 - Hi I'm Christopher , I manage this role Hobson Prior are seeking for a CMC Lead Drug Substances to join a fantastic biotech establishment on a...

  • Cmc Lead

    vor 2 Wochen

    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...

  • Cmc Lead Drug Substances

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Hobson Prior Vollzeit

    Salary:CHF CHF165000 per annumJob type:PermanentLocation:Basel, SwitzerlandFunction:Technical Operations, Quality Control, ChemistPosted:05/05/2023Ref:BBBH2220- Hi I'mChristopher, I manage this roleHobson Prior are seeking for a CMC Lead Drug Substances to join a fantastic biotech establishment on a permanent basis located in Basel. Our client is focused on...

  • Drug Substance Cmc Lead

    vor 4 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Drug Substance CMC Lead** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic...

  • Drug Substance Cmc Lead

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Drug Substance CMC LeadSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Key...

  • Drug Substance Tech Project

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz NonStop Consulting Vollzeit

    Technical Project and Product Leader in Drug Substance Development and ManufacturingAre you a dynamic Chemist or Chemical Engineer with a passion for pharmaceutical development? We are seeking a highly skilled Technical Project and Product Leader to join our client's team in Allschwil, Switzerland. In this role, you will lead and manage the development,...

  • Director of Regulatory Affairs Cmc

    vor 2 Wochen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Director of Regulatory Affairs CMC - CDMO Switzerland for a pharmaceutical consultancy. This role is on a permanent basis and is located in Basel. **Responsibilities**: - Lead the system owners through the issuance, proposal and upkeep of all regulatory documents such as DMF's, CMC documentations for INDs, IMPDs, NDAs, MAAs,...

  • Head of Cmc

    vor 4 Wochen

    Basel, Schweiz Sobi Vollzeit

    The Role As Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing. You will work closely...

  • Head of Cmc Program Management

    vor 4 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Head of CMC Program...

  • Head of Cmc

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    The RoleAs Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing. You will work closely with...

  • CMC Lifecycle Project Lead

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz NonStop Consulting Vollzeit

    **CMC Lifecycle Project Lead - Exciting Opportunity for Chemists and Chemical Engineers with a PhD**Our client, an international pharmaceutical manufacturing company based in Basel, is at the forefront of innovation, with a fantastic pipeline and heavy investment in ground-breaking projects. Joining our multi-cultural team will not only provide you with...

  • Head of Cmc Program Management

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Head of CMC Program...

  • Analytical Project Leader

    vor 1 Woche

    Basel, Schweiz Novartis Vollzeit

    390288BR **Analytical Project Leader (M/F/d) (80-100%)**: Switzerland **About the role** Location: Basel, Switzerland Role Purpose: We are looking for an Analytical Project Leader to support Analytical Research & Development which sits within the Global Technical R&D department of Global Drug Development and plays a crucial role in the characterization...

  • CMC Lifecycle Project Lead

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz NonStop Consulting Vollzeit

    CMC Lifecycle Project Lead Exciting Opportunity for Chemists and Chemical Engineers with a PhDOur client, an international pharmaceutical manufacturing company based in Basel, is at the forefront of innovation, with a fantastic pipeline and heavy investment in ground breaking projects. Joining our multi-cultural team will not only provide you with great...

  • Manager QA, Commercial Drug Substance and

    vor 1 Woche

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Reporting to the Director, Quality Assurance Commercial Drug Substance the Manager QA will support Quality improvement initiatives, ensure robust processes and systems are implemented across Moderna commercial Drug Substance operations, and help ensure consistent maintenance of the Drug Substance platform. The incumbent will provide oversight...

  • CMC Lifecycle Project Lead

    vor 2 Wochen

    Basel, Schweiz NonStop Consulting Vollzeit

    **CMC Lifecycle Project Lead - Exciting Opportunity for Chemists and Chemical Engineers with a PhD**Our client, an international pharmaceutical manufacturing company based in Basel, is at the forefront of innovation, with a fantastic pipeline and heavy investment in ground-breaking projects. Joining our multi-cultural team will not only provide you with...

  • Technical Project Lead

    vor 2 Wochen

    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...

  • Technical Project Leader Drug Product

    vor 4 Wochen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project Leader - Drug Product (5175 ADA)** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a **Technical** **Project Leader Drug Product** to join their late-stage development and commercial oral dosage forms and lead the drug product development...

  • Technical Project Leader Drug Product

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Technical Project Leader - Drug Product (5175 ADA)Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Technical Project Leader Drug Product to join their late-stage development and commercial oral dosage forms and lead the drug product development of various oral...

  • Technical Project

    vor 3 Wochen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project & Product Lead - Drug Product (Oral Dosage) - 5752 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 Product (Oral...