Company Overview

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METiS Therapeutics Inc is a biotechnology company with a unique technology platform that has the potential to drive best-in class drug assets in a wide range of therapeutic areas. Through the integration of machine learning, quantum simulation, and high-throughput experimentation, we enable scientists to rapidly, comprehensively, and intelligently develop novel drug candidates. ucross-disciplinary expertise and deep industry experiences allow METiS to harness AI to boldly deliver revolutionary therapies for patients with serious diseases.

 

We are seeking a highly skilled, motivated, and collaborative CMC Leader to join our team. This position will offer the opportunity to lead a portfolio of projects that span from discovery to clinical development. The right person will play an important role in the success of our R&D projects, and therefore of the company. This is a very attractive opportunity for a biotech or pharmaceutical industry leader who enjoys a high-energy environment and a highly visible role that offers a chance to make significant contributions to METiS’ pipeline.

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Responsibilities

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• Provide leadership, working with internal and external partners, to ensure scientific excellence in CMC study design, data collection and interpretation, and manage to objectives, budget and timelines 

• Manage multiple development and manufacturing efforts for drug substances and drug products 

• Build strong relationships with internal teams and external C(D)MOs 

• Build strong internal and external relationships with key stakeholders (e.g. analytical, drug substance, formulation, manufacturing, project management, etc.). Facilitate a highly cross-functional environment through engaged leadership, collaborative interactions and a data driven, quality focused mentality 

• Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary 

• Guide CMC activities through interactions with multidisciplinary teams and SME’s. 

• Support clinical supply manufacturing, change control implementation and technical investigations as needed 

• Assist project management to proactively build detailed CMC timelines providing technical clarity, project risks, resourcing and decision points 

• Prepare and keep current written CMC development strategies in alignment with overall program objectives. Present results and progress of CMC programs to internal and external audiences as appropriate 

• Support knowledge management strategies and execution needed for regulatory filings and a commercially viable drug product. Provide subject matter expert scientific review of CMC sections of regulatory documents

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Minimum Qualifications

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• PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, Chem. Engineering, or related scientific discipline required.  

• Minimum 8+ years pharmaceutical industry experience in CMC, including drug substance and drug product development 

• Experience leading a program from pre-IND to clinical development, with late-stage development experience a significant plus 

• Experience with working with CDMOs 

• Working knowledge of FDA/ICH/EMA guidelines and cGMPs, phase appropriate development strategies across IND-NDA stages and global requirements for IND and NDA submissions (or their regional equivalents) is highly preferred. 

• Experience with IND/BLA/MAA writing and review 

• Strong technical/analytical skills to identify and solve problems 

• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners 

• Strong organizational skills in order to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget 

• Exhibits high initiative, strong drive and follow-through

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Preferred Qualifications:

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• Experience in RNA or protein drug development is a plus;  

• Ability to communicate in Mandarin would be advantageous, although not imperative.

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​RECRUITING & STAFFING AGENCIES: METiS Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to METiS or its employees is strictly prohibited unless contacted directly by METiS recruiting team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of METiS, and METiS will not owe any referral or other fees with respect thereto.