Associate DirectorDirector, Drug Product CMC

Overview

Monte Rosa Therapeutics (MRT) seeks to recruit an Associate Director / Director Drug Product CMC to play a key role in advancing our drug product development programs from early-stage development through commercialization. The successful candidate will join the CMC group supporting Monte Rosas portfolio of molecular glue degraders (MGDs) that eliminate disease-causing proteins previously thought undruggable.

The Associate Director / Director drug product (DP) will lead technical development activities related to formulation design drug product development manufacturing and clinical supply for Monte Rosa growing pipeline. This individual will be part of the CMC group and work cross-functionally with analytical drug substance quality clinical operations and regulatory to ensure development of robust and phase appropriate supply strategies across the product lifecycle from early phases to late stages. Strong experience in Drug Product development of small molecule APIs spanning from early to late phase experience in outsourcing and CDMOs management the desire to work in a fast-paced dynamic environment excellent team working and cross-functional collaboration are critical in this role.

Responsibilities

• Develop the most appropriate formulations for NCE molecular glue degraders primarily for oral dosage forms.
• Study and define formulation strategies based on chemico-physical .
• Work closely with drug substance experts to define suitable development strategies and plan related activities.
• Supply drug product through external vendors to support preclinical (PK studies etc) and clinical studies.
• Hands on management of scale-up of tox formulation and supply related material.
• Directly manage and supervise work at external vendors including process development scale-up manufacturing trouble shooting and material supply with high level of independence.
• Identify select and manage with high level of autonomy appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate process development work and for the supply of required drug product.
• Drive drug development activities (scale-up tech transfer formulation changes) at each stage of development from Phase 1 to Phase 3 and into
• Optimize and characterize formulation processes by defining critical process parameters and quality attributes and supervise process validation campaigns at CDMOs.
• Author review and approve CMC sections of regulatory documentation (IND IMPD or MAAs).
• Represent the CMC function in cross-functional teams contributing to strategic decision-making and project planning and providing updates at different levels. Act as a CMC lead as appropriate coordinating DS and DP activities and related analytical aspects.
• Management of timelines resources and budget.
• Liaise with the regulatory team for drafting and reviewing documents for INDs and other regulatory submissions.
• Partner with project teams to seamlessly advance our small molecule development candidates into clinical development

Qualifications

PhD or MSc in Pharmacy Chemistry or related scientific discipline.

PHD with 10 years of relevant experience or MS with 18 years of relevant experience in the pharmaceutical or biotech industry including manufacturing of drug products.

Proven expertise in formulation science process development and scale-up for oral dosage forms including formulation; experience with different pharmaceutical dosage forms (e.g. tablets capsules parenteral pediatric etc.) and in solubility enhancement and amorphization techniques.

Experience in large molecules development and different dosage forms (IV parenteral pediatric etc) is a plus.

Strong understanding of quality-by-design (QbD) principles and regulatory expectations for CMC development.

Work experience in late phase development (validations and registration campaigns commercial TPP etc) and in NDA filings.

Understanding technical development from clinical to commercial stage.

Experience of managing CDMOs and complex supply chains.

Excellent communication and leadership skills with the ability to collaborate across multidisciplinary and international teams.

Flexibility hands-on attitude problem solving skills team player and ability to adapt to a highly dynamic environment.

Required Experience :

Director

Key Skills

Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation

Employment Type : Full-Time

Experience : years

Vacancy : 1