Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience as Pfizer Animal Health, we deliver quality medicines and vaccines, complemented by diagnostics products and genetics tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.
Post: Principal Investigator
Job Description:
RESPONSIBILITIES
The incumbent will be responsible for conducting formulation research and development activities on new chemical entities and reformulation of existing drug products for Pfizer Animal Health. The area of formulation research includes solid and liquid dosage forms for oral, topical and parenteral administration. 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 candidate would design and perform / manage pre-formulation, prototype formulation and scale up studies as part of product development and subsequently the transfer of the processes and technologies to commercial manufacturing sites. As part of the project activities, the incumbent will be expected to collaborate 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. The candidate will be responsible for writing and reviewing protocols, reports, SOPs, CMC technical sections for regulatory submission. Work on novel drug delivery systems internally or through external partners will also be conducted / managed. The individual is expected to lead teams that bring forward the drug substance, drug product, analytical methods and drug supplies for drug candidates from the early discovery stage to registration and commercialization. Effective communication and leadership skills are essential. The position would involve managing some direct reports as well as some lab work.
QUALIFICATIONS
WORK EXPERIENCE/SKILLS:
MINIMUM: Ph.D. with ~10 years formulation research experience (~15 years in case of Masters degree) in pharmaceutical R&D organization.
Demonstrated capability to perform independent research 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 ATTRIBUTES DESIRABLE:
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.
Additional Information:
Experience: 10-15 Year
Location: Thane
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 31st Dec., 2013
APPLY THRUOGH RECRUITERS PORTAL
See All D.Pharm Alerts B.Sc Alerts Thane Alerts
See All Other Jobs in our Database
.png)
