Position Overview:
The Associate Director will lead and oversee pre-formulation and early formulation development strategies crucial for advancing drug candidates from concept through initial clinical trials. This role is vital for our drug development pipeline, directly influencing patient outcomes. The ideal candidate will have a robust background in pharmaceutical sciences and formulation chemistry, along with proven leadership skills.
Key Responsibilities:
- Lead and manage all aspects of pre-formulation and early formulation development projects, ensuring alignment with project timelines and objectives.
- Collaborate with discovery research, preclinical teams, and DMPK to assess and optimize the biopharmaceutical properties of new chemical entities (NCEs) using advanced drug delivery technologies.
- Develop and implement standardized methodologies for pre-formulation screening and create decision trees to facilitate informed formulation selection.
- Oversee formulation selection, process development, scale-up, optimization, and tech transfer at contract development and manufacturing organizations (CDMOs), ensuring compliance with regulatory standards.
- Prepare, review, and approve essential documentation, including GMP manufacturing batch records, development reports, study protocols, and CMC regulatory submissions (e.g., IND, IB).
- Plan and execute solution and solid-state pre-formulation studies to support candidate selection and meet regulatory requirements, ensuring robust data generation.
- Mentor junior scientists and promote a culture of innovation and continuous learning within the team, fostering professional growth and technical expertise.
Qualifications:
- 5+ years (with PhD), 8+ years (with MS) or 10+ years (with BA/BS) of relevant experience in pre-formulation, biopharmaceutics, and physicochemical characterization relevant to small-molecule drug product development.
- In-depth understanding of physical chemistry principles, including pKa, LogP/LogD, solubility, solid-state properties, and molecular optimization techniques.
- Proven track record in formulation and process development across various clinical stages, with hands-on experience in solid oral dosage manufacturing unit operations.
- Familiarity with analytical techniques such as HPLC, LCMS, XRPD, DSC, and TGA, with the ability to apply these in formulation development and characterization.
- Knowledge of ICH guidelines, GMP regulations, and industry best practices related to drug development and manufacturing processes.
- Excellent written and verbal communication skills, with experience in technical writing for regulatory submissions and the ability to effectively communicate complex concepts to diverse audiences.
Education:
- BA/BS or MS or PhD in chemical engineering, chemistry, pharmaceutical sciences, or related field
* The anticipated salary range for candidates who will work in South San Francisco, CA is $180,000 to $200,000. The final salary offered to a successful candidate will be dependent on 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 industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
