Director, CMC (Small Molecule Drug Substance)

At HotSpot, we’re not just looking for the brightest minds or for 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.

#Courageous Adventurers #Leave your Mark #Keep it Human #Make it Real

SUMMARY:

Reporting to the Vice President, CMC and QA, this 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 many CRO/CMO partners. The candidate will be responsible for a variety of activities including but not limited to the following:

RESPONSIBILITIES: 

• Oversight of CMC vendors, including adherence to quality, budget and timeline metrics.
• Collaboration with internal team and external partners and vendors to ensure integrated and quality driven production of drug substance to enable FIH (First In Human) regulatory packages and subsequent clinical studies.
• Proactive identification, communication, and appropriate mitigation of key CMC risks.
• Authoring of key elements of CMC regulatory documents and responses.

 QUALIFICATIONS: 

• Advanced scientific degree with at least 8-10 years of CMC experience in the biopharma industry.
• Strong scientific and technical track record in small molecule product development (drug substance process development, scale up, manufacturing and analytical testing).
• Demonstrated experience of management/oversight of CGMP activities (including technical review of master and executed batch records, oversight of manufacturing activities).
• Experience of management of contract development and manufacturing organizations.
• Familiarity with requirements for regulatory submissions in major global regions.
• Attention to detail, critical analysis of data/reports, and troubleshooting/root cause analysis abilities.
• Ability to adapt to and effectively manage change in a fast paced, lean, dynamic environment
• Outstanding verbal and written communication skills and strong organizational skills.
• This role is hybrid offering lots of flexibility and located in the Boston Seaport area

OUR BENEFITS:

We believe that people are our greatest resource and foster a supportive environment that provides growth and development for all. We recognize and reward performance and incentivize long-term success. From benefits that focus on your health and well-being to competitive compensation to equity ownership, we want to inspire our employees to be their best!

Our Benefits Include, But Are Not Limited To:

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

Amazing team of supportive colleagues

At HotSpot, we have a bold mission to establish a new drug discovery paradigm. If this appeals to you, please let us know at iamcurious@hotspotthera.com.

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.

HotSpot requires its employees to be fully vaccinated against COVID-19, as defined by the CDC. Additionally, HotSpot employees are required to comply with state, local, and vendor COVID-19 vaccination requirements.