Assoc. Pharmaceutical Development Director

Job # 597674 Pharmaceutical Manufacturing Company is seeking: POSITION: Assoc. Pharmaceutical Development Director LOCATION: Caldwell, New Jersey SALARY: $150-170K + Bonus DEGREE:  Required EXPERIENCE: 7-10 Years Progressive R&D Background with at least 3 years in sterile injectable products along with Generics RELOCATION: Assistance Available.   General Description This position has responsibilities over formulation, analytical, drug delivery, and for operational and support functions for clinical development through commercial registration. Serve as the pharmaceutical development representative in corporate and partner project teams assuring alignment of work scope to resources and budget. Handle fill/finish GMP contract manufacturing for clinical to commercial DP batches which may include review and implementation of manufacturing batch records, SOPs, stability protocols, analytical method transfer and validation protocols. Set and justify DP specifications and author regulatory filing content, from early clinical studies through product registration. Responsible for preform/formulation, and other development studies including prototype stability, dose handling-administration, extractable/leachables, packaging, investigations and/or process qualifications to support GMP compliance and regulatory submissions. Perform and oversee analytical and physical testing including HPLC, LC/MS, viscosity, turbidity, osmolality, moisture content, and UV/Vis spectrometry. Compose reports on preform/formulation, manufacturing process, and related activities. Interface with outside parties including CMOs, vendors, analytical labs, and partners. Author and Approve ANDA, 505(b)(2) and IND Submissions and filings Prepare, organize and manage execution of technical due diligence plans, as required during partnering considerations The position will support all aspects of drug product formulations and cGMP fill/finish manufacturing operations, along with laboratory development work, and analytical testing. The individual will be an independent self-starter with experience designing and manufacturing sterile injectable drug products under cGMP along with significant writing of various reports and drug product sections of CMC regulatory submissions. The position has the additional responsibility to pursue the development of new formulations or delivery methodologies that may benefit the Ionis technology. The intent on this responsibility would be to identify and prioritize those approaches considered of value to Ionis and to acquire proof of concept data which would show their utility to the oligo technology platform. The position also works well within a multidisciplinary team with an ability to be productive and successful in an intense, fast-paced, work environment. Effective interaction skills, along with excellent oral and written communication ability, are an essential component of this position. REQUIREMENTS: Bachelor's degreerequired, graduate degreepreferred, in science or engineering. Minimum of 7-10 years' experience in a pharmaceutical technical development to commercial discipline, with 3 years experience with sterile injectable products. Comprehensive understanding of cGMP requirements and stage appropriate CMC regulatory requirements, both domestic and international (i.e., ICH) for clinical and/or commercial pharmaceutical manufacturing. Demonstrated experience managing aseptic cGMP manufacturing operations, directly or outsourced, from initial tech transfer through method and process validation. Experience leading cross-functional teams across development functions: manufacturing, specifications, development studies (stress, E/L, etc.), stability, shelf-life, packaging etc. Demonstrated experience authoring and reviewing drug product sections of regulatory CMC submissions for parenteral products.
Salary Range: $150K - $170K
Minimum Qualification
8 - 10 years

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