What You'll Do:
- Manage development, validation, and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs.
- Establish and justify specifications for drug substances, starting materials, intermediates, and drug products.
- Oversee in-process testing, release testing and stability studies of drug substance and drug products at CMOs/CTLs, and trend stability and release data using statistical methods.
- Identify and characterize drug impurities and degradation products.
- Review and approve analytical results, protocols and reports.
- Participate in, review findings, and approve reports for analytical investigations.
- Collaborate with the Clinical Technical Operations team, including Manufacturing, QA, and CMOs/CTLs towards timely authorship and approval of documents and release of batches for clinical and pre-clinical use.
- Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams.
- Author technical reports and documents, including the preparation of CMC documents to support regulatory filing.
About You:
- PhD in chemistry or pharmaceutical sciences with minimum 8+ years of experience in QC Analytical, including analytical development.
- Experience in early to late-stage drug development.
- Experience working with lipid formulated drug product is preferred.
- Experience in working with CMOs and CTLs.
- Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization techniques.
- Extensive knowledge in ICH, cGMP and regulatory requirements.
- Proven track record in applying analytical techniques to solve challenging problems.
- Excellent communication skills, both written and oral, with the ability to influence and collaborate across all levels of the organization. Strong interpersonal skills to build trust and maintain relationships with internal and external stakeholders.
- Solutions-oriented, self-driven, and able to think critically and strategically in a rapidly evolving environment. Passionate about contributing to Circle’s growth and mission.
- Comfortable working resourcefully in a small, startup environment.
- Enjoyment in operating in an exceptionally dynamic, high-achieving and collaborative environment where every voice matters.
- Demonstrated willingness to lead, champion, and operate with Circle’s Core Values.
- Ability to travel domestically and internationally, up to 10%.
Additional Preferred Skills:
- Experience with the preparation of IND applications and other regulatory documents is highly desired.
- Experience managing external analytical development and technology transfers is highly desired.
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What We Do
Circle Pharma initiated operations in June 2014 with seed funding from Pfizer, Inc. and Mission Bay Capital, LLP; we received additional seed funding from ShangPharma Investment Group Limited in November 2015. We recently raised Series B and Series C financing from The Column Group and NextTech Invest.
We design and develop bioavailable macrocyclic peptide therapeutics against important clinical targets. We do this by applying a computational structure-based design approach that combines physics (conformational modeling), chemistry (innovative molecular components) and biology (protein target structure and function). We have selected intracellular protein-protein interactions that play key roles in cancer as the initial target group for our internal pipeline development.
Circle is taking a new approach to the development of macrocylic peptide therapeutics that is based on the pioneering work of its founders to understand and computationally predict drug-like properties of macrocycles. Circle is advancing this understanding to design novel, inherently permeable macrocyclic peptide drug candidates against Circle’s internal targets and those of our collaboration partners.
Our workflow includes the use of proprietary algorithms to design large, conformationally diverse, virtual libraries of cell permeable macrocyclic scaffolds that incorporate natural and non-natural backbone components. We deploy these virtual scaffold libraries in subsequent design steps that include the incorporation of functional side chains selected for both target binding and maintenance of permeability. Candidate compounds are synthesized and tested for both permeability and target affinity and the results are used to inform subsequent design cycles.
