Sr. Associate Scientist/ Scientist

Responsibilities:

The incumbent will be responsible for supporting analytical research and development activities (methods development, validations, transfers, documentation, stability, etc.) for formulation or API projects within the sphere of NCEs, LCM and generics. The person hired into this position will work in close collaboration with other functional line colleagues (chemistry, formulation, API scale up etc.) to best support product and process development in line with project plan. Candidate will be responsible for supporting multiple projects and the interfacing with various customers and partner groups across the organization such as global development team, regulatory, quality, manufacturing and clinical organizations as well as coordinate the analytical activities outsourced to vendors. The candidate will be responsible for authoring/reviewing various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc. Projection and effective management of resources to ensure timelines, budgets and deliverables are met as per project requirements will also be a part of the role.

Essential skills / competencies

• In depth understanding and knowledge of applications of various modern analytical tools and technologies, including modern techniques for separation science (e.g., HPLC, NMR, GC, LC/MS, Dissolution etc.)
• Experience with pharmaceutical analysis including raw materials, intermediates, API analysis or various drug product types including solids, and liquids for oral, topical, and parenteral administration; including work around stability, characterization / isolation of impurities and with a strong, proven track record of analytical problem solving for various types of products.
• Knowledge and interpretation skills of in-process analyses, pre-formulation studies, degradation pathways, stress stability designs, stabilization techniques and biopharmaceutical aspects of drug products.
• Good understanding of quality requirements in analytical support for clinical supplies and manufacturing transfer work.
• Good understanding of chemistry and formulation processes; basic knowledge on Design of Experimentation (DOEs) and optimization techniques.
• Experience of authoring regulatory documents for filing to regulatory agencies may be an added skillset.
• Good at interpersonal, leadership, communication and presentation skills are essential.
• Excellent documentation skills for recording research work and ability to summarize results and data in concise memos, development reports, summaries etc.; experience of supporting regulatory documents (e.g., validation reports, specifications, stability reports, development summaries, CMC technical sections) for filing to regulatory agencies.

Other attributes desirable

• Exhibits a thorough understanding of own scientific/technical area. Stays current with new developments and trends in that area and their application to development projects.

• Uses knowledge and experience to design, conduct and interpret data from experiments. Plan work independently based on specific objectives. Prioritizes tasks; keeps management/team informed of progress and adjusts work accordingly. Displays knowledge of project goals.
• Demonstrates the ability to identify and recommend solutions for problems that arise during experimentation. Identifies and utilizes the most reliable resources to get at the root of a problem.
• Understands safety. Considers safety an integral part of planning for and performance of work function.
• Communicates technical information efficiently and accurately. Practices active listening skills to understand information being communicated by others. Can deliver articulate presentations in a team environment. Writes clearly and concisely. Maintains laboratory notebook meeting corporate standards.
• Modifies techniques and work processes to improve the way work is done, introducing imaginative approaches, and championing new technologies to improve group/team performance.
• Recognizes the importance of relationships within the work group. Builds a sense of partnership with others in the work group to achieve results. Builds and maintains a strong network with people from other departments to enhance collaboration on assignments.
• Experience of working as part of international teams, working with contract research organizations or Marketing / Commercial colleagues and familiarity of the Animal Health industry would be good.

Qualifications

• PhD / M Pharm / MSc in Analytical / Pharmaceutical Chemistry / Instrumentation with 5-10 years of experience in Industry.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.