Director, QC Analytical

Circle Pharma is a dynamic biotech company advancing the discovery and development of cell-permeable oral macrocycles. Our platform combines structure-based drug design and advanced synthetic chemistry to create first-in-class macrocycle therapeutics for severe unmet clinical needs. We are focusing our development efforts on cyclins, which are master regulators of the machinery that controls progression of cells through the cell cycle and are key drivers in many cancers.

We seek passionate individuals poised to drive our growth and make a difference. Learn more about Circle Pharma at www.circlepharma.com

Circle Pharma is seeking an experienced and highly collaborative Director, QC Analytical. Reporting to the VP, Clinical Technical Operations, this individual will be a critical member of the CMC Team and will lead our QC Analytical effort. This role is based out of our headquarters in South San Francisco, CA and requires regular onsite presence.

• 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.

• 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%.

• 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.

This position is based in Circle’s South San Francisco office and requires regular on-site presence at least 3 to 4 days per week. 

Circle Pharma recognizes that the success of our endeavors depends on the success of every team member. Your well-being is our top priority, and we are proud to offer a comprehensive total rewards package. Our benefits include but are not limited to medical, dental, and vision care. We also provide a 401(k) plan with a generous company contribution, and all of our offers contain a stock option component. We provide company-paid life insurance, short-term and long-term disability. Additionally, we provide many company-paid holidays, including a winter break at the close of the calendar year. 

Circle Pharma is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, gender identity, disability status, membership in an organization or any other non-merit factors.