Associate Researcher

We are seeking a Sr Scientist for a very important client.Responsibilities include:Provide technical input, oversight and direction to assigned projects and activities in support of process improvements to current methods.Lead the external laboratory collaborations including reviewing data packages, test results, lab investigations and any method transfersCoordinate external laboratory data and information with the internal teams for product release/ annual stabilityWrite and review test methods, method verification/validation protocols, and method verification/validation reports.Participate in cross functional teams as a representative of the Analytical Quality Control group.Support internal/external audits for the analytical/CMC related topicsProvide mentoring and coaching to the Analytical Development staff when neededResponsibilities may include the following and other duties may be assigned. Responsible for the initiation, design, development, execution, and implementation of scientific research projects. Investigates the feasibility of applying scientific principles and concepts to potential inventions and products. Plans and executes laboratory research. Maintains substantial knowledge of stateofthe art principles and theories and may contribute to scientific literature and conferences. May participate in development of patent applications. May coordinate interdepartmental activities and research efforts. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .TECHNICAL SKILLSMust HaveIn this exciting role as a Senior Scientist, you will have responsibility for analytical test development, method verifications and validation in support of new and existing combination product Quality Control. The Senior Scientist will require a variety of technical skills including HPLC, UPLC, GC, Dissolution/Elution (USP Apparatus 2), FTIR, GPC and Karl Fisher. The individual will make and record observations; perform calculations; and collect and prepare data for evaluation.. This individual will perform technical and recordkeeping duties in conformance with company policies, current Good Lab Practices (cGLP), current Good Manufacturing Practices (cGMP), and technical procedures in Quality Control/Assurance and/or Research and Development group. In addition, the individual will be the liaison between the external laboratories that are doing testing with the internal stakeholders as the analytical/CMC lead ensuring product releases are done in a timely manner and all the regulatory compliance requirements are met.Thorough knowledge and experience with cGMP and ICH guidelines Experience in developing and validating analytical test methodsNice To HaveHM's Top 3:Technical skills as describes in the job description (HPLC, UPLC, GC, Dissolution/Elution (USP Apparatus 2), FTIR, GPC and Karl Fisher)Experience on method development/ validationExperience in advanced data analysisEducation Required: Requires a Baccalaureate degree and minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience. Nice to have advanced degree in Chemistry

Created: 2025-01-26