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Process Chemist (PhD required)


  • Beacon Hill Staffing Group - Pharma
  • 05/17/20
  • New Town, MA
  • 02456
  • 100,000 / Yearly
  • Full-Time
SUMMARY:

The role of Scientist in Process Chemistry will be responsible for the development of robust, well-understood processes and the timely manufacturing of cGMP materials using outside vendors. This will involve the identification and documentation of key process parameters, relevant process controls, the origin of impurities, and appropriate strategies for control of product quality. The role will further provide chemical development subject matter expertise during quality events and regulatory submissions.

RESPONSIBILITIES:

Work with contract R&D partners to develop robust, phase-appropriate processes for production of small molecule raw materials, intermediates and APIs
Design experiments to define reaction, isolation and purification processes, identify design space, and confirm robust process performance under cGMP conditions
Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
Support vendor management activities, including vendor selection, technology transfer, and cGMP manufacturing campaigns
Represent Process Chemistry in internal cross-functional CMC teams
o Collaborate with Formulation Development and Analytical Development to define and execute development strategies that enable phase appropriate deliverables
o Effectively summarize key information such as program progress, timeline updates, and risk/opportunity assessments for CMC teams and management
o Conduct scenario planning to proactively provide analysis and recommendations on alternative development plans, along with associated assumptions and risks
Investigate, identify root causes, and approve CAPAs for manufacturing deviations
Contribute to process risk assessments, process validations, and other commercialization -related API activities from clinical development through product approval and beyond.
Assist in the evaluation of CMC documents during due diligence exercises and the review of source documents during regulatory filing preparations

QUALIFICATIONS:

PhD + 2 years relevant experience in pharmaceutical process chemistry in a cGMP environment
Strong knowledge of modern synthetic organic chemistry and drug development processes
Experience in cGMP manufacturing
Good interpersonal and organizational skills with demonstrated ability to manage projects
Experience working well in interdisciplinary teams and CDMO vendors
Strong critical thinking and problem-solving skills
The ability to perform under pressure, manage external vendors, and work effectively in a fast-paced environment
Working knowledge of regulatory guidelines
Experience in supporting IND/IMPD or NDA/MAA submissions a plus


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