Associate Research Scientist

SUMMARY

This position will work with senior staff under some supervision for analytical method development, validation, and transfer, stability testing and activities to support regulatory filing and clinical studies in compliance with all applicable guidelines. This position will be involved with conducting routine and advanced laboratory analysis and method development/validation. This position participates in preparation of laboratory Standard Operating Procedures (SOPs), methods, protocols, and reports. This position will be responsible for certain laboratory instrument maintenance/qualification to ensure they are compliant with established procedures and cGMP requirements. This position will maintain accuracy in scientific data and notebook writing.

PRINCIPAL ACCOUNTABILITIES

(Describe in a series of brief statements up to five of your primary job responsibilities or activities in descending order of importance, including safety responsibilities and travel requirements if any.)

• Participate analytical method development to characterize and ensure quality of the drug products.
• Perform analytical testing and generate data to understand and support formulation development of drug products.
• Perform stability testing and data trending.
• Perform analytical method validation and transfer with internal and external teams
• Write and review test methods, protocols and reports to accurately document completion of tasks.
• Prepare and present data summaries (written and oral) as necessary.
• Assist investigations, problem solving and troubleshooting. Write investigation reports.
• Operate and maintain all analytical instrumentation and equipment as per established procedures. Responsible for certain laboratory instrument maintenance and qualification.
• Write and revise SOPs.
• May provide training and assistance to other group members.
• Comply with all safety, regulatory and corporate procedures and policies to ensure that the laboratory is a safe and effective workplace.
• Performs other related assignments and duties as required and assigned.

JOB SPECIFICATIONS QUESTIONNAIRE

1. KNOWLEDGE

Describe the specific knowledge required to perform the job. Indicate why each component is necessary to successful job performance. Consider understanding of facts, theories, terminology, concepts, disciplines, processes, or techniques used on the job. Describe formal academic, vocational, or on-the-job training, self-education; progressive work experience required.

• B.S. in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry.
• Demonstrate some understanding, working knowledge of analytical chemistry, separation sciences, spectroscopy, and other hands-on analytical techniques.
• Good understanding and working knowledge of industry guidance (cGMP, GLP, etc.).
• Basic experience in pharmaceutical method development, validation and transfer.
• Skillful in HPLC, dissolution, disintegration, GC, FTIR, UV, KF and wet chemistry.
• Knowledge of Waters Empower chromatography software, Waters online HPLC Automated Dissolution and Fusion software.
• Familiar with Sotax Automated Sample Preparation Workstation
• Able to independently identify/observe problems and recommend solutions.

2. PROBLEM COMPLEXITY

Describe the "thinking challenge " of the job: the nature of the problems to be solved and data interpreted; the extent to which originality, innovation, and creativity are required. Consider the nature of the work itself, variety of assignments, availability of guidance and direction, the scope of tasks, and the time frame under consideration.

• Frequent use and/or application of technical theories, principals and concepts.
• Can recognize and bring problems to the attention of supervisor.
• Troubleshoot and develop solutions to a variety of technical problems.
• Demonstrate inquisitiveness in conducting experiments.
• Make creative suggestions for experimental procedures.

3. FREEDOM TO ACT (Exempt Only) Describe the discretionary authority of the job and the direction exercised over it. Consider its role in establishing and/or affecting organizational goals, policies, and procedures. Include restrains imposed by internal written instructions, policies, or procedures, and external laws and regulations. Consider time frame of work objectives, task diversity, and initiative expected, permitted or required. Work under general direction with some supervision. May independently determine and develop procedures and approaches to follow. Work is reviewed as it progresses.

4. IMPACT

Describe the impact of the position on company, work unit, or product line results. Consider impact in terms of financial input/output (revenues, expenses, assets, budget) and human resources (organizational span of control). Indicate the importance of errors, if made, the likelihood of error, and a cost associated with correcting those errors. Contribute to productivity of the department and/or project team through the completion of milestones associated with technical advances, documentation and trouble shooting. Failure to obtain results or erroneous decisions or recommendations will cause delays in projects and programs impacting overall financial results. 5. SUPERVISORY RELATIONSHIP/DIRECT WORK INVOLVEMENT (Exempt Only) Explain the supervisory responsibilities of the job. Consider the depth of the supervisory chain of command, both above and below the position, the nature of the work force directed, and the nature of the work itself. To what extent does the incumbent perform duties similar to those of superiors or subordinates? Keep supervisor informed of progress, problems or suggestions for improvement. Collaborates with other team members of Analytical Research and Development to fulfill project needs. Communicates effectively with Product Development, project management and other functional groups.

6. LIAISON

Describe the job requirements for communicating effectively with others, inside and outside the company. Keep in mind the nature of the communication, ranging from uncomplicated exchanges of information up to complicated discussions and negotiations. Describe the significance, purpose, and frequency of contacts, and their potential impact on company operations and good will. Contacts are primarily with immediate supervisor, project leaders, and other colleagues in the group or project team. Should have more cross functional contacts outside of the immediate group or team. Should prepare reports and present work internally