Head of CMC & QA (Small Molecule)

Head of CMC & QA (Small Molecule) Full-time, hybrid role based in Boston, MA. About HotSpot Therapeutics, Inc. At HotSpot Therapeutics, nature is inspiring us to create a wave of new medicines. Through a proprietary technology platform, we are uncovering privileged allosteric sites used by nature to control proteins – natural hotspots– that can be exploited through small molecule drug discovery. Regulatory hotspots are allowing sought‑after targets to be drugged for the first time while delivering molecules with exquisite selectivity and attractive drug‑like properties. HotSpot is supported by a syndicate of leading healthcare investors based in the US and Europe. You will be joining a seasoned team of drug hunters with an excellent track record in drug discovery. We’re not just looking for the brightest minds or the most brilliant individual contributors. We want passionate team members who are comfortable adjusting their lens, aren’t afraid to think big, test bold ideas, and celebrate collective wins. We have established core values that resemble who we are and define our company culture. We are building a company where values drive everything we do inside and outside the organization.

SUMMARY

This CMC and QA leadership role is key to progressing HotSpot’s programs to clinical development. The successful candidate will be a hands‑on leader working cross‑functionally to support delivery of HotSpot’s goals for initiation and delivery of clinical development programs. The successful candidate must have a ‘can do’ attitude and be able to work independently but also be an effective partner and communicator in a matrix organization involving colleagues across R&D and CRO/CDMO partners.

RESPONSIBILITIES

In consultation with senior advisors, lead CMC strategy and execution to support delivery of HotSpot development programs. Drive CMC activities (including technical oversight of external vendors/CDMOs) to ensure on time, integrated and quality driven production of API/drug substance, drug product (oral solid dose) and clinical supply to support preclinical needs and enable FIH (First In Human) data packages and initiation of clinical studies. Develop strategy for and author CMC regulatory documents, including Health Authority submissions and responses. Carry out ongoing reviews of the CMC and vendor strategy to ensure delivery of multiple parallel programs, pressure test key assumptions and balance preclinical and clinical supply needs of each program with risk, cost and operational efficiencies. Working with an external Quality vendor, ensure ongoing compliance and maintenance of the HotSpot Quality Management System to support evolving requirements.

QUALIFICATIONS

Advanced scientific degree with 10 – 15 years experience of execution and delivery of CMC programs in the biopharma industry, preferably in small organizations. Strong scientific and technical track record in small molecule product development (including small molecule process development, formulation development, scale up, CGMP manufacturing and analytical testing). Knowledge of all components of CMC, including drug substance development, analytical development, drug product development (oral solid dose), quality, project management, CMC regulatory affairs, and clinical supply chain. In‑depth knowledge of relevant pharmaceutical product development guidelines and health authority requirements across major worldwide markets. Demonstrated experience of management/oversight of CGMP activities at CDMOs including technical review of master and executed batch records. Cross functional knowledge of Quality Assurance systems and compliance requirements. Outstanding verbal and written communication skills and strong organizational skills. Proven track record in working on cross‑functional drug development teams and work streams with demonstrable indications of successful contributions. This role is hybrid offering lots of flexibility and located in the Boston Seaport area.

OUR BENEFITS

Competitive salary and discretionary bonus plans New hire stock option award Medical, Dental, Vision plans and fringe benefits Generous paid holidays, time off, including 2 company‑wide shutdowns Hybrid, flexible work model: approx. 2 days/per week on site HotSpot is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. At this time, HotSpot is not able to offer Visa sponsorship for this position. Candidates must be authorized to work in the United States without current or future sponsorship. #J-18808-Ljbffr B Capital