Scientist / Senior Scientist CMC – Fast Hire

We are on the lookout for a confident Scientist / Senior Scientist CMC to join our incredible team at Monte Rosa Therapeutics, Inc in 4057 Basel, BS.

Growing your career as a Full Time Scientist / Senior Scientist CMC is an incredible opportunity to develop productive skills.

If you are strong in cooperation, problem-solving and have the right mindset for the job, then apply for the position of Scientist / Senior Scientist CMC at Monte Rosa Therapeutics, Inc today!

Overview

To support our growing pipeline, we have an exciting position at Monte Rosa. The CMC team is expanding and looking for a senior scientist CMC to lead the supply of drug substance and drug product for our small molecule programs. The successful candidate will be involved in Chemistry Manufacturing and Controls tasks from preclinical stage to clinical and commercial. This includes but is not limited to managing outsourcing activities for development and manufacturing of both drug substance (including synthesis design, trouble shooting, process development) and drug product, contributing to the quality section of regulatory submissions, helping out to establish internal processes for shipments, quality, etc. Superior experience in process development of small molecule API in fast paced environments and in early phase formulation are considered an asset. The candidate should also have excellent skills for working in a collaborative and cross-functional, dynamic environment.

Responsibilities
Responsible for drug substance and drug product activities from preclinical phase through clinical development and beyond.
Develop and implement strategies to manufacture drug substance including process development, manufacturing, procurement of raw materials, phase appropriate analytical development activities.
Management of timelines, resources and budgets.
Act as CMC lead in project teams by participating to project meetings and give regular updates.
Liaise with medicinal chemistry team to seamlessly advance our small molecule development candidates into clinical development. Identify opportunities for strategic sourcing to reduce timelines to the clinic.
Conduct physico-chemical and solid state studies of small molecule drug substances including polymorphism, solubility etc. to assess developability and formulation strategies for clinical development and commercialization.
Identify, select and manage 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).
Write, edit and review 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 (for PhD) or 5 (for MSc) years of experience in the pharmaceutical or biotech industry in areas such as chemical or analytical development & scale-up, manufacturing, pre-formulation/formulation, CMC with small molecule drugs.
Sound knowledge of organic chemistry and process development of small molecule API. Knowledge of formulation development (mainly solid oral dosage forms) considered a plus.
Excellent interpersonal, communication and teamwork skills.
Flexibility, problem solving.
Experience in the GMP manufacturing of drug substances or in the GMP manufacturing of drug products.
Experience with projects in clinical development (Phase 1 through Phase 3) is considered a plus.
Experience in different pharmaceutical dosage forms (e.g. tablets, capsules, parenteral, etc.) is considered a plus.
Experience with cGMP manufacturing and IND, CTA and NDA filings thorough knowledge of relevant FDA and EMEA regulations is considered a plus.
Experience in supply chain management is considered a plu

Company Benefits
Learning opportunities
Company offers career progression opportunities
Advantageous package

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