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Job #02650

About our client Our client is a rapidly growing pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various immunology diseases therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Drug Product Development Cambridge, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure that all APIs and drug products for peptides portfolio are manufactured, packaged, labeled and distributed on time to support clinical trials and commercial development of products as per cGMP and ICH requirements 2) Establish development plan and lead associated pre-formulation/characterization activities for dosage development of parenterally administered drugs from pre-clinical through commercial development 3) Select/recommend third-party manufacturers 4) Work with Quality and Regulatory personnel to negotiate effective supply/technical agreements 5) Identify contract analytical laboratory sites required to guide and support third-party manufacturing relationships 6) Direct/oversee contract manufacturing, packaging and labeling operations for the company's pharmaceutical ingredients and drug products 7) Act as primary liaison with contractor(s) on assigned projects 8) Guide external operations through technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations 9) Work with Quality Assurance to develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc. 10) Direct development of the Dosage Form for research and development 11) Work with Regulatory, QA and senior management to ensure adherence to all company policies 12) Ensure all external manufacturing activities comply with relevant regulations 13) Maintain knowledge of current best practices of drug delivery 14) Identify emerging trends and technologies and lead implementation/feasibility assessment (as appropriate) 15) Handle development and execution of plan-design to support global submissions 16) Participate in regulatory filings (domestic and international) with Regulatory and Quality personnel 17) Review and approve master and executed batch records from all manufacturing activities 18) Release testing, stability studies and investigations (as required) 19) Develop production plans to support clinical and commercial development (adjust plans as appropriate to meet corporate objectives) 20) Oversee internal formulation and analytical development activities that contribute to timeline acceleration (as appropriate) 21) Perform other duties as required Requirements 1) Ph. D./MS or equivalent in Immunology or a related field 2) Minimum 10 years of related experience in the biotechnology industry with at least 5 years in GMP manufacturing, including clinical development experience 3) Experience (direct) in drug product development, including analytical, formulation and dosage formulation development 4) In-depth knowledge of cGMPs for drug products 5) Knowledge of immunology and inflammation preferred 6) Experience with parenteral product development and manufacturing 7) Experience in working with contract service providers, including technical transfer, site qualification and supervision of activities 8) Strong understanding of pharmaceutical development, quality assurance and regulatory compliances (domestic and international) 9) Experience in early to late phase preferred 10) Knowledge of import/export a plus 11) Ability to work towards deadlines and adhere to time schedules 12) Ability to work effectively to solve problems in a multidisciplinary team environment 13) Excellent communication (written and verbal) skills 14) Excellent computer skills (MS Office, etc.)