20 beste Stellen als executive director, regulatory strategy in basel bs – aktuell auf Personalsuche

Scientist I/II Analytical CMC & QC
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 95’000 - CHF 125’000 pro Jahr
- 100%
- Doktorat
- Master
- Qualitätskontrolle
Scientist , CMC Process Chemistry
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 100’000 - CHF 130’000 pro Jahr
- 100%
- Doktorat
- Master
- Produktion
Lead of Health Economics & Access Evidence (m/f/d)
Viatris —Allschwil, BL
- 100%
- Homeoffice
- Microsoft Excel
- Doktorat
- Master
3 Tage
RWX Global Supplier Relationship Manager
Sandoz —Basel, BS
- 100%
- Management-Erfahrung
- Englisch
- Master
4 Std.
Global Head of Device Technology and Strategy
Roche —Basel, BS
- 100%
- Doktorat
- Englisch
- Master
Sr. Scientific Director, Clinical Pharmacology
Neurocrine Bioscience —Allschwil, BL
- 100%
- Doktorat
- Master
- Bachelor
Digital Measures Lead
Roche —Basel, BS
- 100%
- Doktorat
- Englisch
- Führungserfahrung
Medical Director (MD), Multiple Sclerosis
Roche —Basel, BS
- 100%
- Management-Erfahrung
- Doktorat
- Führungserfahrung
Director GSCM Network & Demand Center (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Excel
- Management-Erfahrung
- Pensionskasse
Chief Medical Officer
Swiss Biotech Association —Reinach, BL
- Doktorat
- Englisch
- Kommunikationsfähigkeit
Analytical Molecular Characterization Team Lead and Mass Spectrometry Scientist
Roche —Basel, BS
- 100%
- Doktorat
- Master
- Führungserfahrung
Global Senior Strategic Sourcing Manager
Sobi —Basel, BS
- 100%
- Hybrides Arbeiten
- Englisch
- Bachelor
- Verträge
Direkt bewerben
Marketing Manager AT/CH
Mundipharma —Basel, BS
- 100%
- Management-Erfahrung
- Englisch
- Kommunikationsfähigkeit
Director, Integrated Product Medical Lead (m/f/d)
Bayer —Basel, BS
- Doktorat
- Englisch
- Patientenversorgung
QA Engineering Specialist
PM Group —Basel, BS
- Englisch
- Microsoft Office
- Bachelor
1 Tag
Head of Clinical Scientists, Oncology Early Clinical Development
Roche —Basel, BS
- 100%
- Doktorat
- Teamleitung
- Führungserfahrung
DMPK-PD Project Leader (2-year temporary position)
Roche —Basel, BS
- 100%
- Doktorat
- Führungserfahrung
- Kommunikationsfähigkeit
Senior Statistical Methodology Data Scientist
Genentech —Basel, BS
- 100%
- Doktorat
- Mentoring
1 Tag
Senior Trademark Counsel
Abbott Laboratories —Basel, BS
- 100%
- Spanisch
- Englisch
- Kommunikationsfähigkeit
1 Tag
Operational Excellence Business Partner Bubendorf (a) 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Doktorat
- Englisch
- Forschungserfahrung

Ich möchte aktuelle Job-E-Mails für Stellen als executive director, regulatory strategy in basel bs erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

executive director, regulatory strategy jobs near basel bs

Scientist I/II Analytical CMC & QC

Monte Rosa Therapeutics, Inc
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
CHF 95’000 - CHF 125’000 pro Jahr

Qualifikationen

Doktorat
Klinische Erfahrung
Master
Qualitätskontrolle
Produktion
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Overview:

To support our growing pipeline, we are looking to fill an exciting position at Monte Rosa Therapeutics. The CMC team is looking for a Scientist, Analytical CMC& QC with Analytical expertise to support analytical activities related to the development and supply of drug substance and drug product for molecular glue degrader (MGD) programs. The successful candidate will be involved in Chemistry, Manufacturing and Control activities from preclinical to clinical and potentially commercial stage. This includes but is not limited to managing, monitoring and guiding analytical activities, such as methods development, phase appropriate validations, stability studies, release of non-GMP and GMP material, defining appropriate control strategies and QC oversight for both drug substance and drug product. In addition, contributions to the quality section of regulatory submissions are expected. Superior experience in analytical development fields and in Quality Control of small molecule API in (early) phase development is considered an asset. The candidate should also have excellent skills for working in a collaborative and cross-functional, dynamic environment.

Responsibilities:

Oversees drug substance and drug product analytical activities from preclinical phase through clinical development and beyond.
Guides and reviews analytical reports, analytical methods, validation and stability protocols and reports and release documentation.
Participates to the Contract Development & Manufacturing Organizations (CDMO’s) oversight as analytical responsible person
Offers guidance to the CDMO including troubleshooting.
Identifies, selects and manages appropriate CDMO’s for appropriate development and manufacturing work of drug substance and drug product under cGMP.
Applies and defines phase appropriate analytical strategies according to ICH guidelines for both drug substance and drug product.
Reviews/authors corresponding quality sections for regulatory submissions.
Supports the development and implementation of manufacturing strategies for drug substance and drug product.
Is responsible (as needed) for drug substance and drug product development and manufacturing activities from preclinical phase through clinical development and beyond.
Manages timelines, resources and budgets as needed.
Partners with project teams to seamlessly advance our small molecule development candidates into clinical development.
Identifies opportunities for strategic sourcing to reduce timelines to the clinic.
Overall accountability for drug supply chain in preclinical and clinical trials.

Qualifications:

PhD or MSc in Organic or Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences or related scientific discipline.
Two (for PhD) or five (for MSc) years of experience in the pharmaceutical or biotech industry in analytical areas such as method development and validation, release and stability studies for drug substance and/or drug product of small molecules.
Work experience on the main analytical techniques for drug substance /or drug product. Good understanding of organic synthesis and process development of small molecule API. Knowledge of formulation development (mainly solid oral dosage forms) is considered a plus.
Experience in analytical development for projects in clinical development (Phase I through Phase III).
Thorough knowledge of ICH guidelines and most relevant FDA and EMA regulations.
Excellent interpersonal, communication and teamwork skills.
Flexibility, problem solving, ability to work in a dynamic environment.
Experience in different pharmaceutical dosage forms (e.g. tablets, capsules, parenteral, etc.) is considered a plus.
Experience with cGMP manufacturing of both drug substance and drug product and IND, IMPD, NDA and MAA filings is considered a plus.

Jetzt bewerben

Erweiterte Suche

executive director, regulatory strategy Jobs in basel bs

Scientist I/II Analytical CMC & QC

Scientist , CMC Process Chemistry

Lead of Health Economics & Access Evidence (m/f/d)

RWX Global Supplier Relationship Manager

Global Head of Device Technology and Strategy

Sr. Scientific Director, Clinical Pharmacology

Digital Measures Lead

Medical Director (MD), Multiple Sclerosis

Director GSCM Network & Demand Center (a), 100%

Chief Medical Officer

Analytical Molecular Characterization Team Lead and Mass Spectrometry Scientist

Global Senior Strategic Sourcing Manager

Marketing Manager AT/CH

Director, Integrated Product Medical Lead (m/f/d)

QA Engineering Specialist

Head of Clinical Scientists, Oncology Early Clinical Development

DMPK-PD Project Leader (2-year temporary position)

Senior Statistical Methodology Data Scientist

Senior Trademark Counsel

Operational Excellence Business Partner Bubendorf (a) 100%

Ich möchte aktuelle Job-E-Mails für Stellen als executive director, regulatory strategy in basel bs erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt