Pace Analytical

Scientist I – Pharmaceutical Development

US-MA-Woburn
ID
2017-1911
# of Openings
1
Category
Science

Overview

Want to be part of a company whose goal is to provide outstanding pharmaceutical discovery and development services by creating and using cutting edge science and developing new methods and molecules? Do you want to work with some of the brightest minds in the industry in a rapidly growing company on a trajectory to have a major impact in the life science research arena? We are seeking a talented and passionate scientist who is eager to be part of our success, and who embraces our core values: Integrity, Excellence, and Teamwork. This role requires a highly driven and proactive scientist with a passion for drug development, the curiosity and flexibility to work on diverse projects, and the tenacity to tackle complex questions by developing/applying new methods to solve previously intractable problems in drug development in a dynamic, fast-paced, team-oriented and collaborative environment.

 

We are seeking a Scientist I in the area of pharmaceutical development. Wolfe Laboratories conducts rational formulation development that leverages a molecular understanding of the pharmaceutical and biopharmaceutical attributes for the delivery of drugs, including poorly soluble drugs, via conventional and non-conventional oral formulations as well as complex parenterals. The successful applicant will be a key member of the team and will be responsible for understanding characteristics of candidate drugs and developing and executing the formulation approach that will be most successful. Furthermore, the successful candidate will define performance criteria for any products developed to ensure that clinical performance of manufactured product is acceptable. The company utilizes a wide range of in vitro (both biology and physical/analytical chemistry based), 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.

Responsibilities

  • Plan, design, coordinate, set priorities, and at times, lead teams to manage programs of work to achieve project targets in a timely fashion and to agreed quality standards by applying technical knowledge and expertise
  • Aid and influence the selection of formulations from a product design perspective
  • Manage programs of experimental work and predictions to characterize and understand the pharmaceutical properties (physicochemical and biopharmaceutical) of drug substances and formulations
  • Implement and/or lead project work and other improvement activities
  • Evaluate physicochemical properties of small molecules relevant to drug development and subsequently communicate the interpretation and implication of results to clients
  • Develop analytical methods and characterize product variants
  • Execute and oversee specialized analytical testing and generation of technical documents
  • Maintain a strong awareness of current scientific literature, particularly in the area of drug substance and drug product characterization, and actively apply new concepts as appropriate
  • Design experiments to develop pre-clinical and clinical formulations of drug candidates to support drug discovery and development
  • Design experiments to determine the stability in prototype clinical formulations, to detect and identify the decomposition products, and to achieve formulations with acceptable shelf-life
  • Perform laboratory experiments related to the above
  • Assess and report data with a clear understanding of its reliability, interpret findings, and draw authoritative conclusions and recommendations so that their significance can be appreciated
  • Apply technical knowledge to the company improvement projects and the evaluation of new technology/processes. Collaborate with specialist scientific and/or technology teams
  • May supervise co-workers and contribute to their training and development by acting as coach/mentor, giving immediate feedback, as appropriate. Develop personal performance by actively seeking feedback and support from peers
  • Will present information for discussion at project teams. Will be expected to influence colleagues in other areas/functions and/or in external groups
  • Will work as a member of cross-functional teams, with a large degree of independence representing own area of expertise
  • 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
  • Engage clients in development of solutions by applying a broader perspective
  • Write persuasive proposals for the projects
  • Regularly interact with clients to keep them abreast of project progress
  • Write and review interim and final reports

Qualifications

  • PhD. in pharmaceutical chemistry, organic chemistry, biochemistry, chemical engineering or closely related discipline
  • Two or more years of experience in drug development from the post discovery phase to the initial clinical trials phase
  • In depth expertise in biopharmaceutics
  • Expertise in the field of physicochemical analysis and structural characterization
  • Hands-on experience with method development as well as analytical methods used for physicochemical characterization of pharmaceutical products such as spectroscopy and HPLC analysis
  • A demonstrated drive to apply technical knowledge to developing drug delivery systems and formulations
  • Established track record of significant contributions as an individual technical expert as well as the ability to thrive in a multi-disciplinary team environment
  • Outstanding written and oral communication skills as well as polished and persuasive client presentation skills
  • Flexibility and outstanding time management skills to provide the full range of pharmaceutical support (including project representation) across many projects

Perferred:

  • In depth drug development expertise in two or more of the following formulation types: liquid, lyophilized, dispersed systems, solids, and/or semi-solids
  • Expertise in HPLC, LC/MS, DSC, TGA, and other analytical techniques
  • Ability to propose realistic reaction mechanisms for drug degradation prior to identification of actual decay products
  • Facility with computational chemistry tools to predict physical properties
  • Demonstrated capability with in silico pharmacokinetic models for predicting exposure following oral or parenteral administration

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