Job for Principal Scientist at Zoetis | M.Pharm / Ph.D

The incumbent will be responsible to support analytical research and development activities for NCE (new chemical entity), LCM (life cycle management) and NEB (new established brand) projects. 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 various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc.

Post: Principal Scientist

Responsibilities
The incumbent will be responsible for leading a team of scientists engaged in conducting formulation research and development activities on generic molecules, reformulation of existing drug products for life cycle management and new chemical entities. The area of formulation research includes solid and liquid dosage forms for oral, topical and parenteral administration to animals. The scope of research activities would typically include pre-formulation, prototype formulation and scale up studies as part of product development and subsequently the transfer of processes and technologies to commercial manufacturing sites. The position will involve developing and executing technical plans to meet target drug product profiles through in house research as well as external collaborations. The incumbent will be expected to ensure effective collaboration with various stake holders and customer groups such as global development team, regulatory, quality, manufacturing, marketing and clinical organizations for successful and timely delivery of clinical supplies and manufacturing process transfers. Other than the research activities the candidate will also be responsible for maintaining and delivering required documentation such as protocols, reports, SOPs, CMC technical sections for regulatory submission etc. Effective communication skills, leadership skills and people development skills are essential. The position would involve managing direct reports and travel up to about 25% of time.

Qualifications :
Ph.D. with ~10-12 years formulation research experience (~15 years in case of Masters degree) in pharmaceutical R&D organization. Demonstrated capability of delivering technically challenging formulation research projects through independent research as well as through leading technical teams is essential.

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Essential skills / competencies

Excellent knowledge of pre-formulation and formulation development activities and processes for solid and liquid dosage forms
Proven track record of developing commercial dosage forms including scale-up and technology transfer experience to pilot/commercial scale
Basic knowledge on Design of Experimentation and Quality by Design aspects for formulation development
Extensive knowledge and interpretation skills of drug degradation pathways, stress stability designs, stabilization techniques and biopharmaceutical aspects of drug products
In-depth understanding of packaging considerations for commercial products and primary pack screening and selection activities
Excellent understanding of GMP and knowledge of ICH, Pharmacopoeial, Technical and Regulatory requirements in relation to pharmaceutical product development and manufacturing
Experience of authoring regulatory documents for filing to regulatory agencies and commercial launch
Proven leadership of pharmaceutical science development teams
Good at interpersonal, leadership and communication skills