20 beste Stellen als clinical trial in basel, bs – aktuell auf Personalsuche

Scientist , CMC Process Chemistry
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 100’000 - CHF 130’000 pro Jahr
- 100%
- Doktorat
- Master
- Produktion
Scientist I/II Analytical CMC & QC
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 95’000 - CHF 125’000 pro Jahr
- 100%
- Doktorat
- Master
- Qualitätskontrolle
Head of Clinical Scientists, Oncology Early Clinical Development
Roche —Basel, BS
- 100%
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Neurocrine Bioscience —Allschwil, BL
- 100%
- Doktorat
- Master
- Führungserfahrung
Head Clinical and Commercial Drug Substance Supply
Roche —Basel, BS
- 100%
- Führungserfahrung
Internship in Global Clinical Materials Management (Kaiseraugst)
Roche —Kaiseraugst, AG
- 100%
- Schreibfähigkeiten
- Englisch
- Master
Data Scientist (Translational Data, Transfers & Statistics – Phase I)
Ridgeline Discovery —Basel, BS
- Teilzeit
- Doktorat
- Master
- Python
Direkt bewerben
Senior Statistical Methodology Data Scientist
Genentech —Basel, BS
- 100%
- Doktorat
- Mentoring
12 Std.
Associate / Global Medical Science Leader
Roche —Basel, BS
- 100%
- Doktorat
QA Deviation Management Specialist
Thermo Fisher Scientific —Allschwil, BL
- 100%
- Englisch
- Qualitätskontrolle
- Organisationstalent
12 Tage
Director / Associate Director – Toxicology
Monte Rosa Therapeutics, Inc —Basel, BS
- CHF 150’000 - CHF 200’000 pro Jahr
- 100%
- Doktorat
- Forschungserfahrung
- Master
6 Tage
Sr. Scientific Director, Clinical Pharmacology
Neurocrine Bioscience —Allschwil, BL
- 100%
- Doktorat
- Master
- Bachelor
Chief Medical Officer
Swiss Biotech Association —Reinach, BL
- Doktorat
- Englisch
- Kommunikationsfähigkeit
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management
BeiGene —Basel, BS
- CHF 105’800 - CHF 186’100 pro Jahr
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
Epidemiologist
Universitäre Altersmedizin FELIX PLATTER —Basel, BS
- 100%
- Doktorat
- Schreibfähigkeiten
- Datenanalyse
- Pensionskasse
Senior HEOR Manager Patient-Reported Outcome (12 months contract) m/f/d
Bayer —Basel, BS
- Doktorat
- Forschungserfahrung
- Master
1 Tag
Digital Measures Lead
Roche —Basel, BS
- 100%
- Doktorat
- Englisch
- Führungserfahrung
Senior Statistical Methodology Data Scientist
Roche —Basel, BS
- 100%
- Doktorat
- Mentoring
19 Std.
Head of Pharmaceutical R&D PTDC-F
Roche —Basel, BS
- 100%
- Führungserfahrung
Associate Director Quality - Client Dedicated Process & QD Manager (m/w/d)
IQVIA —Basel, BS
- 100%
- Management-Erfahrung
- Englisch
- Microsoft Office
5 Tage

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Jobs als Clinical Trial Leader in Basel, Bs

Scientist , CMC Process Chemistry

Monte Rosa Therapeutics, Inc
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
CHF 100’000 - CHF 130’000 pro Jahr

Qualifikationen

Doktorat
Klinische Erfahrung
Master
Produktion

Vollständige Stellenbeschreibung

Overview:

In this exciting role the successful candidate will contribute to CMC tasks from discovery/preclinical stage to clinical and potentially commercial stage. This includes managing outsourcing activities for development and manufacturing of drug substance from early phase onwards, including route scouting, process development and compounds supply from pre-IND to clinics. The role might imply involvement in drug product development activities from and early formulation to development and manufacturing. Strong experience in process chemistry of small molecule APIs, the desire to work in a fast-paced dynamic environment, excellent team working and cross-functional collaboration are critical in this role.

Responsibilities:

Delivery through external vendors of drug substance including route scouting, process research and development, scale-up, manufacturing and material supply activities from preclinical phase onwards with high level of independence.
Assessment or existing routes of synthesis, bottles necks identification and design of alternatives and synthesis solutions. During manufacturing and scale-up, trouble shooting, process and analytical development.
Contribute to the development and implementation of strategies to manufacture drug substance including process development, procurement of raw materials, phase appropriate analytical activities and control strategies.
Management of timelines, resources and budgets.
On assigned projects, act as CMC lead and point of contact in cross functional project teams by participating in project meetings and provide regular updates. As CMC lead, involvement into drug product development activities might also be required.
Establish a strong interaction with medicinal chemistry to support as needed early development efforts ensuring syntheses improvements as early as possible.
Liaise withtoxicology and clinical teams to seamlessly advance our small molecule development candidates into preclinical & clinical development.
Manage physico-chemical and solid state studies of small molecule drug substances including polymorphism, solubility, early formulation studies, etc. to assess developability and formulation strategies for clinical development and commercialization.
Identify, select and manage with high level of autonomy appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate process development work and for the GMP supply of drug substance and drug product.
Prepare, review, edit CMC regulatory and quality documents (batch records, analytical validations, reports and protocols).
Liaise with the regulatory team for drafting and reviewing documents for INDs and other regulatory submissions.
Responsible for drug supply chain in preclinical and clinical trials.

Qualifications:

PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical sciences or related scientific discipline.
2-7 years of relevant experience in the pharmaceutical or biotech industry in areas such as: process chemistry , chemical or analytical development, scale-up, manufacturing (pilot or large scale), pre-formulation/formulation with small molecule drugs.
Sound knowledge of organic chemistry and process development of small molecule API.
Understanding of technical development from preclinical stage till clinical phases.
Experience of GMP manufacturing drug substances and/or drug products.
Experience of managing CDMOs and complex supply chains.
Other desirable experience: large molecule development and formulation; experience with different pharmaceutical dosage forms (e.g. tablets, capsules, parenteral, etc.), support of clinical development (Phase 1 through Phase 3) including IND, CTA and NDA filings; FDA and EMEA regulations are considered a plus, process validation/registration experience.
Needs to be highly effective in cross-functional and cross-site teams.

Jetzt bewerben

Erweiterte Suche

clinical trial Jobs in basel, bs

Scientist , CMC Process Chemistry

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Director, Clinical Development

Head Clinical and Commercial Drug Substance Supply

Internship in Global Clinical Materials Management (Kaiseraugst)

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Associate / Global Medical Science Leader

QA Deviation Management Specialist

Director / Associate Director – Toxicology

Sr. Scientific Director, Clinical Pharmacology

Chief Medical Officer

Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management

Epidemiologist

Senior HEOR Manager Patient-Reported Outcome (12 months contract) m/f/d

Digital Measures Lead

Senior Statistical Methodology Data Scientist

Head of Pharmaceutical R&D PTDC-F

Associate Director Quality - Client Dedicated Process & QD Manager (m/w/d)

Ich möchte aktuelle Job-E-Mails für Stellen als clinical trial in basel, bs erhalten

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