Pace Analytical

  • Associate Director - Biologics

    ID
    2018-3006
    # of Openings
    1
    Job Locations
    US-MA-Woburn
    Category
    Science
  • Overview

    Wolfe Laboratories LLC., a subsidiary of Pace Analytical Life Sciences, is a premier Contract Research and Development Organization located in Woburn, MA, providing pharmaceutical development services for small molecules, biologics, oligonucleotide therapeutics, and other biopharmaceutical drug candidates.

     

    We are currently seeking an Associate Director of Pharmaceutical Development for Biologics and Oligonucleotides to support the rapid growth of our organization. We are looking for individuals with a solid understanding of the analysis and/or formulation of biopharmaceutical products including proteins, antibodies, and oligonucleotide therapeutics including DNA, RNA, RNAi, etc., as well a good working knowledge of the drug development process. This position will be responsible for the scientific leadership and management of biopharmaceutical client projects so that they will be accomplished on time, within budget, and according to the company’s quality standards, as well as managing internal and external resources and communicating/coordinating progress of projects.  The ideal candidate must be comfortable working in a dynamic and fast changing environment, be able to execute on different projects at the same time and be a team player. 

    Responsibilities

    • Lead client and internal project team members to successful completion of the project in regards to science, time, cost, and quality.
    • Work on complex problems of diverse scope where analysis of data requires evaluation of intangible factors.  Exercise independent judgment in developing methods, techniques and evaluation criteria.  Demonstrate success in technical proficiency, collaboration with others and independent thought.
    • Develop detailed project plan(s), including scope, deliverables, resource planning, budget, duration/schedules, risk management, and reporting
    • Conduct project kick-off, close-out, and regularly scheduled team meetings to keep all relevant stakeholders informed of the progress during the project life cycle
    • Track/manage projects from initiation to successful completion.  Identify and resolve project issues.
    • Chair internal project team meetings, provide agendas, issue minutes with follow-up actions identified
    • Act as single point of contact for the client and facilitate responses to customer questions and observations.
    • Serve as the Scientific Lead for the evaluation of the chemical, physical, and biophysical properties of molecules including peptides, proteins, antibodies, ADCs, and other bioconjugates relevant to biopharmaceutic drug development
    • Guide the development of analytical and high throughput biophysical methods to characterize product variants and understand the pharmaceutical properties of drug substances and formulations.
    • Oversee the execution and development of analytical methods including IP-RP HPLC, LC-MS, CE, DLS, fluorescence, qPCR, etc. to characterize oligonucleotide therapeutics
    • Lead the development of advanced formulations for the efficient delivery of nucleic acids (siRNA, RNA, DNA, and other oligonucleotide drug candidates)
    • Coordination with sales, operations, client services, and QA to ensure the highest level of client service.
    • Communicate any changes in the development program with internal team members and ensure that the changes are fully documented
    • Manage relationships and keep project stakeholders accurately and regularly informed of the project(s) status
    • Manage difficult customer situations, respond promptly to customer needs and solicit customer feedback to improve service
    • Will be able to speak to all Wolfe Laboratories business services and will promote Wolfe Laboratories at client meetings and conferences
    • Identifies and resolves problems in a timely manner and gathers and analyzes information skillfully
    • Contributes to smooth and efficient laboratory operations
    • Other Duties as assigned

    Qualifications

    • PhD in Chemistry, Biochemistry, Biophysics,​ or other relevant discipline.
    • 10-15 years of laboratory experience in analytical chemistry, pre-formulation, and/or formulation development of biotherapeutics.
    • Minimum of 2 years managing small to large-scale projects.
    • Experience in the characterization of proteins and other biotherapeutics by mass spectroscopy and the use of LC-MS for bioanalysis highly desired.
    • Working knowledge of Pharmaceutical and Biotech industries
    • Highly developed analytical chemistry knowledge, and hands-on laboratory experience.
    • Demonstrates a practical and advanced understanding of related scientific disciplines in formulation development.
    • Experience in execution of multiple and/or complex projects.
    • Must have outstanding planning/organization/prioritization skills
    • Must be able to prioritize and plan work activities, and have exceptional time-management skills
    • Must be able to interact effectively with a variety of individuals and personalities within and between departments.
    • Excellent oral and written communication/interpersonal skills required, plus English fluency; the ability to speak clearly and persuasively in positive or negative situations demonstrating leadership, gaining commitment and buy-in for projects

    OFCCP Statement

    Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.

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