This position is no longer open for applications

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

MINIMUM: 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.

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

Other desirable attributes

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