Head of CMC

About the role

Treeline Biosciences, Inc. is a drug discovery company developing small molecule drugs for cancer and other serious diseases. With research sites in Watertown MA and San Diego CA, we are committed to bringing forward drugs that benefit patients.

We are seeking a highly motivated, proactive, solution-focused Head of CMC, who will be responsible for the management of Treeline’s CMC-related activities. This hands-on position will support CMC aspects of development, including process chemistry, route optimization, GMP manufacture and clinical supply, and formulation development.  In this role, the CMC leader will manage multiple priorities in a fast-paced environment, enact quick problem-solving to ensure uninterrupted supply of drug for IND-enabling activities including toxicology studies as well as clinical trials.  The successful candidate will have experience of and an interest in working in a small, dynamic environment with broad responsibilities.

Key Responsibilities

• Oversees outsourced manufacturing, including technology transfer, quality control and product/process development activities for drug candidates from late-stage preclinical development through commercialization.
• Identifies, diligences and selects Contract Manufacturing Organizations (CMOs) for process optimization, formulation work, GMP manufacture and supply.
• Works with CMOs to deliver robust, scalable, and cost-effective manufacturing routes.
• Formulates drug substance and drug product development strategy to meet clinical and commercial needs, ensure product quality, facilitate regulatory approvals, and achieve operational flexibility of supply chain.
• Coordinates with Quality Assurance, when applicable, to implement stage-appropriate analytical methods and ensure that all partner CMOs/CROs are in compliance with all relevant regulatory standards.
• Write and/or review CMC sections of regulatory documents and submissions; represent Treeline as the CMC expert in front of regulatory authorities
• Work collaboratively with relevant internal parties to meet current and future needs of Treeline programs, including uninterrupted drug supply for clinical trials.
• Establish and maintain detailed project plans; define risks and continually evaluate ways to optimize timelines and parallel process while appropriately managing risk.
• Build and lead CMC team as CMC responsibilities grow within the organization.

Qualifications

• PhD with 10+ years of CMC experience in the biotech/pharmaceutical industry, including work with contract manufacturers; advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline.
• Experience in drug substance development, formulation development, process development, clinical and commercial cGMP production including process validation experiments, preapproval inspections, and commercial manufacturing.
• Extensive experience managing US and International CMOs for the manufacture of drug substances and drug products.
• Experience with authoring/reviewing regulatory documents (IND, CTA, NDA), specifically Module 3 sections of an IND/NDA, and FDA information requests, interfacing with regulatory agencies, and knowledge of relevant FDA and EMEA regulations.
• Strong analytical, organizational, and time management skills with a track record of identifying and implementing novel solutions.
• Demonstrated agility and ability to navigate and be successful in a fast-paced, dynamic work environment.
• Proven hands-on leadership and communication skills (written and verbal)
• Team player who is able to work and collaborate effectively with internal stakeholders as well as external contract organizations.
• Self-driven, able to set priorities, and drive results.
• Proven ability to mentor and coach more junior team members and develop a strong scientific team.
• Be a champion of a highly collaborative, transparent, data driven, ‘make it happen’ culture.

This position is classified as exempt. The anticipated annual base salary range for Director- level candidates who will work in San Diego is $210,771 to $232,220. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through Skype or Telegram.
• Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.