Healthcare Pharmaceutical Products Company Seeks Director, Formulation in R&D We are looking for a Director of Formulation in R&D, for a Central NJ-based fully integrated pharmaceutical company, with OTC, Generic, and Brand Rx business. -Supervises and reports overall product development activities to Sr. VP of R&D. -Issues of meeting timeline, enhancement of personal step-up activities. -Analysis and resolutions for projectsprogression blocks specifically of ANDAand generally other projects in lines of R&D layer out. -Duties requirementsencompasses solid dosage a must soft gel plus. -Preformulation as well as formulation development experience. -Screening of polymers and other excipientsselections to enhance low-solubility APIs. -Development of Generic products for ANDA filings. -Group Leader to have combined Pharmaceutical R&D, Solid Oral Dosage Forms, inclusive of Hard Shell Capsules. -Modified release and immediate release solid dosage forms. -Should have knowledge to carry out projects of alternative dosage deliveryvia 505b2. -Design of experiments for robust formulation development. -Manufacturing of feasibility and submission batches for stability & clinical studies. -Performance of scale-up batches. -Documentation development report and CMC documents in support of ANDA filings. -Full knowledge and implementation of quality-by-design (QBD) and GMP regulations in execution of MBR for new products. -Involved in new product transfer to third parties’ facilities. -Perform, review, and analyze the data collected for formulation and process development, establish critical process and attributes for future products development. -Cross-functional activities amongst related companys department needed specifically QA/QC/Regulatory. Interested individuals should contact Ken Zinchiak, at Altitude Staffing at (908) 219-4543 or ken.zinchiak@altitudestaffing. Healthcare Pharmaceutical Products Company Seeks Project Manager, Generics We are looking for a full-time, permanent Project Manager, Generics for a Central NJ-based fully integrated pharmaceutical company, with OTC, Generic, and Brand Rx business. The company and its generic pharmaceutical (Rx)division offers a number of high-quality, cost-efficient products available for commercial distribution. They have an aggressive developmentpipeline in place tomarket highly sought aftergeneric Rxproducts to the US market. This individual will possess Pharmaceutical Generic Drug Development Experience, experience working on programs focusing on the development of generic pharmaceutical products, technical transfer to manufacturing, and coordinating clinical studies with CROs.This drug development experience would include formulation, chemistry, regulator knowledge, etc. Key Responsibilities -Partner with local site heads and teams, R&D team, Regulatory team, Marketing, Supply Chain, Operations, key stakeholders to define project and program objectives, deliverables, and annual and long-range operating work plans; identify resources (eg, FTEs, budget, etc.); and ensure execution and progress toward deliverables and milestones. -Work proactively with respective local and global teams, management, and governance on risk assessments and management. -Develop and maintain comprehensive periodic (eg, weekly, biweekly, and monthly) updates to teams, management, and governance, using various project & program management tools. MINIMUM/ PREFERRED REQUIREMENTS: Education: BA/BS required; MBA preferred; relevant certification and training (eg, PMP, Operational Excellence Lean Six Sigma, etc.) preferred. Experience: 5 to 7 years broad experience in pharmaceutical industry and a minimum of at least 3 years of experience within Generic Pharmaceutical market. -Experience in Operations, CMC, and other related areas with emphasis on project management of commercial product portfolio assets in pharmaceuticals. -Strong understanding of FDA requirements related to Pharmaceuticals. -The ideal candidate will have experience working in a core team environment where you share the time of Subject Matter Experts with other project teams. -Driven self-starter. -Strong communication skills. -Well organized and attention to detail. -Comfortable working in teams, necessary to “follow-up/push” without alienating team members. Interested individuals should contact Ken Zinchiak, at Altitude Staffing at (908) 219-4543 or ken.zinchiak@altitudestaffing.
Posted on: Wed, 16 Jul 2014 05:08:42 +0000
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