Treeline · 5 hours ago
Director, Process Chemistry
Watertown, Massachusetts, United States
Full-time
Onsite
Director/Executive
$211K/yr - $234K/yr
12+ years expTreeline Biosciences is seeking an experienced Director of Process Chemistry to lead process development and oversight of manufacturing for small-molecule drug substances. The role involves collaboration with various teams to ensure successful project execution, technical transfers, and compliance with regulatory standards.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
Responsibilities
Collaborate with medicinal chemistry partners to support candidate selection and developability assessments
Advise and assist with sourcing scaffolds and intermediates as appropriate
Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management
Oversee technical transfer activities between CDMOs as needed to ensure supply continuity
Collaborate with Analytical Development to ensure the development and validation of analytical test methods for drug substances
Ensure timely documentation review and approval to ensure supply continuity (Batch records, specifications, change controls, etc.)
Provide technical input to deviation investigations to assess impact to product and manufacturing processes
Partner with Quality Assurance and CMC Regulatory to develop and implement appropriate processes and controls to ensure drug substance batches meet specifications and adhere to cGMP when required
Partner with the program teams to design API production schedules while maximizing production and cost efficiencies
Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications
Stay current with applicable global regulations and industry standards
Qualification
Required
Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience, in a CMC development organization
Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
Broad experience working with and managing external CDMO partners, including use of performance and quality metrics and MSA negotiation
Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications
Deep understanding of global regulatory requirements for the manufacture, testing, and control of drug substances
Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews
Strong project leadership skills with the ability to manage complex timelines, multiple stakeholders, and evolving program priorities
Exceptional communication and collaboration skills with a proven ability to work cross-functionally in a fast-paced, science-driven environment
Understanding of basic budgeting processes
High level of personal integrity, commitment to excellence and to our patients
Company
Treeline
Treeline (or Treeline Biosciences) is a privately held, clinical-stage biopharma company that aspires to make medicines at the highest level.
51-200 employees
H1B Sponsorship
Treeline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (4)
2023 (3)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$1.09BKey Investors
AI Life Sciences Investments LLCKohlberg Kravis Roberts
2025-09-03Series A· $200M
2024-10-17Undisclosed· $421M
2022-10-11Series A· $261.27M
Leadership Team
Spencer Smith
Chief Financial Officer
Recent News
2025-10-04
2025-10-01
Genetic Engineering News
2025-09-30
Company data provided by crunchbase