Process chemistry is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.
The successful candidate will be responsible for developing state of the art crystallization processes for the isolation of both active pharmaceutical ingredients and intermediates with the objective of controlling key physiochemical and bulk properties. He/she will be responsible for the introduction and development of new particle engineering technologies to allow the manufacture of exquisite particles as well as for developing crystallization process characterization & validation strategies based on QbD principles using statistical and/ or first principle models.
He/she will coordinate the technical transfer of projects to manufacturing as necessary, prepare and coordinate completion of technology transfer documentation, relevant sections of regulatory documents, as well as validation plans and reports.
- Develop crystallization processes for APIs & key intermediates with an emphasis on polymorph, purity & particle properties (such as particle size and shape). Support pre-IND to late stage assets.
- Drive development of strategies for process development & characterization based on QbD principles focused on fundamental understanding of crystallization as well as using statistical and/ or first principle models.
- Responsible for crystallization scale-up and technical transfer to contract manufacturing organizations.
- Responsible for the development of process chemistry s core particle engineering technologies.
- Identifies industry trends and defines/champions the implementation of novel technologies.
- Responsible for authoring relevant sections of regulatory documents, validation plans, reports and pier reviewed manuscripts.
- Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
- Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams.
- Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
- Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.
- Initiates and influences project direction outside department.
- Represents Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.
May supervise others.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
- A Ph.D. degree with 3+ years (5+ years preferred) of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees with a life science or engineering concentration required, with a preference for concentrations in chemical engineering or chemistry
- Extensive experience in crystallization process development and scale-up with an emphasis on polymorph, purity and particle size control.
- Experience in the use of population balance models, statistical models and/ or advanced process control systems preferred.
- Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control preferred.
- Experience in developing continuous crystallization processes a plus.
- Experience in the use of process analytical technologies (FT-IR, NIR, UV-vis, etc.) required.
- Sound knowledge of current Good Manufacturing Practices (cGMP).
- Previous experience with the use of contract facilities and managing technical transfers.
- Experience in working in a multi-disciplinary team environment.
- Previous experience contributing to regulatory filings, preferably experience will late stage filings.
- Experience managing subordinates preferred.
- Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts.
Knowledge and Skills:
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