Scientist (RD3)

States considered:

Role Description

Responsibilities

The incumbent will be responsible in an individual contributor role for supporting analytical research and development activities (method development, validations, transfers, documentation, stability, etc.) for API and drug products. The candidate will be responsible for supporting multiple projects and will work in close collaboration with partner groups across the organization such as global development teams (formulation, chemistry, API scale up, etc.), regulatory, quality, manufacturing and clinical organizations as well as manage analytical activities outsourced to vendors. The candidate will be responsible for authoring and reviewing various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, and CMC technical sections for regulatory submission. The candidate will be responsible for projection and effective management of resources to ensure timelines, budgets and deliverables are met as per project requirements.

Qualifications

M Pharm / M Sc in Analytical / Pharmaceutical Chemistry, or other related discipline with 10-15 years of analytical research experience in Pharmaceutical R&D

Essential Skills / Competencies

• Thorough understanding, knowledge and experience with various modern analytical tools and technologies used in the pharmaceutical industry (e.g., U/HPLC, GC, MS, Karl Fischer, dissolution, particle size, etc).
• Practical analytical experience of working with dosage forms including solids and liquids for oral, topical and parenteral administration. This includes demonstrated experience in the technical areas of stability, characterization / isolation of impurities, and a track record of analytical problem solving.
• Good knowledge of pre-formulation studies, drug degradation pathways, stress stability designs, stabilization techniques and biopharmaceutical aspects of drug products.
• Good understanding of analytical quality requirements for clinical supplies and technical transfer activities.
• Good understanding of the pharmaceutical development process.
• Good knowledge of Quality by Design (QbD) principles and optimization techniques.
• Good interpersonal, communication and presentation skills essential for contributing to project teams and influencing decisions.
• Good documentation skills for recording research and ability to summarize results and data in concise memos, development reports, summaries etc.; experience in writing and supporting regulatory documents (e.g., validation reports, specifications, stability reports, development summaries, CMC technical sections).
• Knowledge or interest in data management, FAIR data principles, and data visualization.

Other attributes desirable

• Stay current with new developments in analytical chemistry and their application to development projects.
• Use knowledge and experience to design, conduct and interpret data from experiments. Plan work independently based on specific objectives. Prioritize tasks; keep management/team informed of progress and adjust work accordingly. Display an understanding of project goals.
• Demonstrate the ability to identify and recommend solutions for problems that arise in the course of experimentation. Identify and utilize the most reliable resources to get at the root of a problem.
• Understand safety. Consider safety as an integral part of planning for and performing daily activities.
• Communicate technical information efficiently and accurately. Practice active listening skills to understand information being communicated by others. Deliver articulate presentations in a team environment. Write clearly and concisely. Maintain laboratory notebook meeting corporate standards.
• Continuously improve techniques and work processes by introducing imaginative approaches and championing new technologies to improve group/team performance.
• Recognize the importance of relationships within the work group. Build a sense of partnership with others in the work group to achieve results. Build and maintain a strong network with people from other departments to enhance collaboration on assignments.
• Work as part of international teams, work with contract research organizations, and have familiarity with the Animal Health industry.
  

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