12 beste Stellen als cmc regulatory 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
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge
BeiGene —Basel, BS
- CHF 178’600 - CHF 223’300 pro Jahr
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
Scientist , CMC Process Chemistry
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 100’000 - CHF 130’000 pro Jahr
- 100%
- Doktorat
- Master
- Produktion
Manager / Sr. Manager – Quality GMP
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 115’000 - CHF 140’000 pro Jahr
- 100%
- Spanisch
- Englisch
CMC Technical Dossier Manager
Sobi —Basel, BS
- 100%
- Microsoft Word
- Management-Erfahrung
- Doktorat
Direkt bewerben
Associate Scientist in Pharmaceutical Development (Fixed- term for 1 year in Basel)
Roche —Basel, BS
- 100%
- Laborerfahrung
- Englisch
- Erfahrung in der IT
7 Tage
Director, Global Regulatory Affairs
Mirum Pharmaceuticals —Basel, BS
- Management-Erfahrung
- Bachelor
- Mentoring
Expert Medical Writer
Viatris —Allschwil, BL
- 100%
- Hybrides Arbeiten
- Schreibfähigkeiten
- Englisch
- Bachelor
9 Tage
Scientist, Pharmaceutical Development & Data Analytics _2 years temporary contract
Roche —Basel, BS
- 100%
- Management-Erfahrung
- Doktorat
- Datenanalyse
Technical Development Leader (TDL) Large Molecules
Roche —Basel, BS
- 100%
- Doktorat
- Master
- Bachelor
Associate Director, Technical Project Leader Drug Product
Idorsia Pharmaceuticals Ltd. —Basel, BS
- 100%
- Doktorat
- Englisch
- Master
2 Tage
Analytical Expert
Sobi —Basel, BS
- 100%
- Homeoffice
- Doktorat
- Master
- Analysefähigkeit
Direkt bewerben
5 Tage

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cmc regulatory 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.

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Erweiterte Suche

cmc regulatory Jobs in basel bs

Scientist I/II Analytical CMC & QC

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Technical Development Leader (TDL) Large Molecules

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