Merck-Wolfe Laboratories Postdoctoral Fellowship

Biopharmaceutics/Solid Form Definition

JOB SUMMARY:

Merck Research Laboratories and Wolfe Laboratories have created a unique postdoctoral fellowship program. In this highly competitive and challenging program, the postdoctoral fellow is expected to conduct basic biopharmaceutics research as well as perform applied R&D. For the basic research project, the successful candidate will be mentored by Merck scientists on research that is expected to generate peer-reviewed publications. For the applied R&D projects, the successful candidate will work with the Wolfe scientific team to advance our clients’ programs from discovery into early clinical development. The postdoctoral fellow will work at Wolfe Laboratories’ Watertown, MA facility.

An understanding of the phenomena governing intestinal absorption of drugs following oral administration is a topic of great interest to both academia and industry. The successful candidate will utilize physical chemistry, pharmaceutics and solid-state chemistry, with a goal of better understanding the mechanistic underpinnings of variable drug absorption as a function of physicochemical properties. Wolfe Laboratories seeks a PhD scientist who will be responsible for the advancement of structure-based approaches to effectively design solid forms for optimal drug product performance, the identification of pharmaceutically-relevant forms through comprehensive polymorph/solvate crystallization screening, and the assessment of relevant physicochemical properties in support of form selection. Several known or hypothesized formulation and release mechanisms will be interrogated, including amorphous solid dispersion supersaturation, precipitation of drug from formulation vehicles or gastric media (i.e., weak bases), and drug release kinetics from hydrophilic (e.g., polyethylene glycol) and lipid (e.g., mono-, di-, and triglyceride) systems. The scientist must have a thorough knowledge of the thermodynamics of drug crystal forms needed to elucidate their phase relationships, a broad understanding of the application of designer solid forms and super saturation strategies for solubilization, and of crystal nucleation and growth kinetics needed to optimize solid form evaluations. The ultimate goal shall be to predict relative pharmacokinetic performance and variability in animals using calculated and measured properties of drug compounds and their formulations.

Collaboration is at the core of our success. The successful applicant will be a key member of the team and will be responsible for understanding dissolution and absorption characteristics of drug forms and formulations. The candidate will utilize a wide range of in vitro, in situ, and in vivo techniques to achieve this goal. Creativity and innovation, built on sound technical knowledge and excellent problem-solving skills, are required in order to meet the challenges posed by today’s new chemical entities.

DUTIES AND RESPONSIBILITIES:

Scientific Responsibilities:

Identify and leverage state-of-the-art technologies to design crystal forms (crystal engineering) and crystallization processes (particle engineering)

Lead, design and/or conduct crystallization screens for drug crystal forms, including salts, cocrystals, polymorphs and solvates

Leverage a variety of physical-chemical characterization techniques to identify novel crystal forms and to assess relevant physical properties in support of crystal form selections for drug products

Design strategies and implement best business practices for comprehensive solid form (salt, polymorph) screening and selection

Develop a thorough understanding of the CM&C development strategy with respect to physicochemical properties and formulation development

Provide effective technical leadership to integrated drug substance and drug product development teams

Ensure understanding and adherence to applicable laboratory quality systems.

Adopt good documentation practices by properly documenting experiments and writing high quality technical reports

Provide mentoring and develop the technical breadth/depth of associate-level scientists responsible for crystallization screening and formulation development

Serve as a corporate technical resource in the chemistry of pharmaceutical solids (polymorphism, crystallization, X-ray diffraction, thermal analysis, moisture sorption analysis, solubility, microscopy, etc.)

Perform laboratory experiments related to the above.

Create publications and presentations for outside scientific meetings and conferences to showcase Wolfe Laboratories’ scientific leadership in the field of small molecule analysis, characterization and formulation development.

Client Interaction Responsibilities:

Interface with clients to develop an in-depth understanding of client objectives and define solutions to meet their program requirements

Develop compelling approaches and solutions to address client needs

Write persuasive proposals for the projects

Regularly interact with clients to keep them abreast of project progress

Write and review interim and final reports.

REQUIRED BACKGROUND AND EXPERIENCE:

PhD in Organic, Physical or Analytical Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or a related field

Up to 5 years of relevant experience in academic or pharmaceutical solid state chemistry

Deep technical knowledge/expertise in organic solid-state chemistry (crystallization, thermodynamics, solid-state characterization) and/or pharmaceutical sciences

Relevant experience in crystallization, physical characterization techniques (i.e., thermal and moisture sorption analyses, microscopy, chromatography, solubility, powder and single crystal X-ray crystallography, solid-state NMR spectroscopy) and dissolution and/or crystal modeling

Outstanding written and oral communication skills as well as polished and persuasive client presentation skills

ADDITIONAL DESIRABLE BACKGROUND OR EXPERIENCE:

Expertise in computational solid-state chemistry (crystal structure prediction, structure solution from XRPD data, structure-property prediction, molecular dynamics simulations, SSNMR chemical shift prediction)

Interested candidates are requested to email a copy of their resume with a cover letter including salary history to: steve.pangione@wolfelabs.com.

Wolfe Laboratories, Inc. (WLI), located in Watertown, MA, is a premier contract research organization that provides integrated early drug development solutions to the biopharmaceutical industry. Wolfe Laboratories is an essential element of the drug development ecosystem, recognized by global and virtual biopharmaceutical companies as a science-driven organization whose mission is to provide outstanding discovery and development services tailored to its clients’ needs for rational formulation development. Wolfe Laboratories integrates the critical path components of early development to ensure that programs advance while meeting rigorous scientific demands with flexibility to address dynamic challenges and aggressive timelines. Wolfe Laboratories’ vision is to improve human health, and we continue to strive towards that goal by embracing our core values of integrity, excellence and teamwork. The company has a high percentage of repeat clients, which is a testament to its long-term commitment of continual investment in its capabilities to meet biopharma’s growing demand for high quality, integrated early development services.

We have a steady 13-year track record of growth, success and profitability.