Senior/Principal Scientist, Formulation Development

Senior/Principal Scientist, Formulation Development

About the role

The Senior/Principal Scientist, Formulation Development is responsible for supporting phase appropriate formulation development for preclinical and clinical use through external CDMO partners. This individual will work closely with CMC, quality, regulatory, and clinical supply through all phases of drug development.

Responsibilities

• Provide technical oversight for formulation development and GMP manufacturing.
• Collaborate with CMC, Medicinal Chemistry, DMPK, Quality, Regulatory, and Clinical supply groups to advance preformulation and formulation plans.
• Proactively manage objectives, timelines, milestones, and budgets for formulation development and manufacturing activities
• Able to critically troubleshoot problems, determine underlying causes, and propose well thought out solutions within existing constraints.
• Develop strong, collaborative working relationships with external partners; critically assess progress and actively drive experimental workplans at external CDMOs.
• Maintain an understanding of current trends and emerging technologies in small molecule formulation development, including bioavailability enhancement.
• Effectively communicate project progress to internal management and external CDMO partners
• Authors technical summaries/reports and participates in the authorship and maintenance of CMC regulatory filings.

Required Qualifications

• Ph.D. in pharmaceutical sciences or related discipline and a minimum of 3-6+ years of relevant pharmaceutical experience in process chemistry; or M.S. in pharmaceutical sciences or related discipline and a minimum of 10-13+ years of relevant pharmaceutical experience
• Formulation development expertise across a broad range of dosage forms. Experience developing phase appropriate drug product development.
• Prior experience working in a virtual CMC development environment with external CDMO partners.
• Strong understanding of GMP requirements for drug product development
• Experience in the preparation and review of regulatory filings (including INDs, IMPDs, or other regulatory dossiers)
• Focused on collaboration. Building and maintaining good working relationships with internal and external stakeholders is essential. Strong communication skills, both written and oral.
• Ability to work in a fast-paced and dynamic corporate environment with changing priorities and meet time sensitive program deadlines.
• Willingness to travel to various meetings or client sites, domestically or internationally when necessary.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $165,491 to $181,963. 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, 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 RingCentral, Skype or Telegram.
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• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)

The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.