If interested, please send your resume to HR@kluspharma.com Director -Formulation Development Direct and manage formulation team to develop generic sterile injectable products including formulation & process development, scale up, technical transfer, exhibit batch manufacturing, ANDA submission, FDA deficiency response and commercial product launch. Requirements BS with at least 10 years, MS or Ph.D. level with at least 8 years of recent pharma industry formulation development, project management, manufacturing, ANDA, QBD experience with sterile injectables including lyophilization products. Previous successful management experience is required. Expertise in cgmps, Regulatory and ICH guidelines / requirements, FDA guidelines and ANDA submission documentation. Excellent Communication skills Experience in suspension products desired. Ability to motivate and mentor other scientists. 制剂配方研究总监 工作地点 : 大普林斯顿地区, 新泽西州 职责描述负责指导和管理配方研究团队, 从事无菌注射剂仿制药品研发, 包括配方及工艺的研发, 工艺放大, 技术转移, 注册批生产,ANDA 申报文件准备提交,FDA 缺陷信回复及药品的商业化生产 职责要求 具有学士学位, 至少 10 年, 硕士或博士学位至少 8 年最新制药行业无菌注射剂仿制药物, 包括冻干产品的配方研发, 项目管理, 药品生产,ANDA 文件申报及 QBD 药品开发经验 具有成功的团队管理经验 有丰富的 cgmp, 注册法规和 ICH 指导原则 / 要求,FDA 的指导原则和 ANDA 申报的知识 有良好的沟通技巧 希望有混悬产品开发的经验 能够激励并指导其他科学家
Director- Analytical Development Location, Monmouth Junction, New Jersey, USA Responsible for technical and operational leadership for Analytical Development team involved in generic sterile injectable product analytical development activities for successful exhibit batches and for timely FDA submissions with minimal deficiencies. Responsible for successful outcomes in developing and validating analytical methods, as well as stability and formulation testing, necessary to support the goals and objectives of generic sterile injectable product development. Requirement PhD with no less than 10 years related sterile injectable analytical development experience of increasing responsibilities within a pharmaceutical setting, or BS/MS with more than 15 years of the same. Experience to include analytical development and validation, performance and coordination of stability studies, troubleshooting, and responding to non-standard corporate needs. Previous successful management and project management experience is required. Proven outstanding communication and collaborative skills. 制剂分析研发总监 工作地点 : 大普林斯顿地区, 新泽西州 职责描述负责制剂分析研发团队技术及日常操作, 从事无菌注射剂仿制药品分析方法研发, 以最少的缺陷, 确保注册批成功生产及向 FDA 及时申报. 开发并验证分析方法, 进行稳定性和配方研究的的检测, 支持无菌注射仿制药品研发的目标和目的 职位要求 生命科学或化学博士有至少 10 年以上, 或生命科学或化学本科及硕士, 拥有超过 15 年的职责逐渐增加环境的无菌注射分析开发经验 有丰富的分析方法开发及验证经验, 仪器操作, 稳定性实验的协调, 故障排除和及时应对非标企业的需求经验 具有先前的成功团队管理和项目管理经验 具有经过实践检验的优秀的沟通和协作能力 Formulation Scientist Formulation development of generic sterile injectable including lyophilizationdrugs.
ANDA project handling with Regulatory documentation for ANDA submissions. Formulation, Stability Study as per ICH guidelines, and technology transfer and scale-up. Requirements BS, MS and PhD. in pharmaceutical science, Chemical or Life Sciences. 2-6 years of related sterile injectable generic formulation, ANDA, OBD experience in a pharmaceutical environment. Demonstrated abilities in the areas of formulation development in injectable including lyophilization with manufacturing experience. Experience in suspension products desired. Excellent communication skills (verbal and technical), interpersonal skills, and problem-solving skills. 制剂配方科学家 工作地点 : 大普林斯顿地区, 美国新泽西州 职责描述 从事仿制无菌注射剂包括冻干药品的配方工艺开发研究, 技术转移, 放大及注册批生产. 准备仿制无菌注射剂 ANDA 报批文件. 按照 ICH 指南从事配方稳定性研究. 职位要求 医药学, 化学和生命科学本科, 硕士和博士 2-6 年的相关医药仿制无菌注射剂,ANDA 文件报批,QBD 的配方研究经验 有很强的配方研制和注射 ( 及冻干 ) 产品生产经验的实际工作能力 希望有混悬产品开发的经验 优秀的沟通能力 ( 口头和技术 ), 人际交往能力和解决问题的能力 Analytical Scientist Responsible for analytical methods development for ANDA liquid, powder fill and lyophilized aseptic injectable products. Develop and validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions. Requirements BS, MS /PhD. level in Life Sciences or Chemistry and have five to seven years experience in analytical methods development in a small molecule product environment.
Must be knowledgeable in a broad range of instrumentation including HPLC, GC, Ion Chromatography and Mass Spectrometry. Experience with analytical method development and reverse engineering for suspension products desired. Excellent communication skills (verbal and technical), interpersonal skills, and problem-solving skills. 制剂分析科学家 工作地点 : 大普林斯顿地区, 美国新泽西州 职责描述负责仿制水针, 粉末灌装和无菌冻干注射产品分析方法研究. 开发和验证新的分析方法, 进 行稳定性研究, 并进行抽样检验, 以支持药品注册报批 职位要求 生命科学和化学的本科, 硕士 / 博士, 并有五至七年 的小分子化学药品分析方法开发经验 必须了解各种仪器, 包括液相色谱, 气相色谱, 离子色谱法和质谱法 希望有混悬产品分析方法的开发及配方解析的经验 优秀的沟通能力 ( 口头和技术 ), 人际交往能力和解决问题的能力 Sr. Manager/Director, New Product Selection & Product Launch Strategy /BD Job Description US injectable and ophthalmic ANDA product Selection and Business Development: Selection strategies for new ANDA products that maximize profitability (eg, IP strategy, registration, marketing risk and litigation settlement, product preference) and based on business, marketing, and other public information, Responsible for the management of the company's investment portfolio for the selection of new varieties. Product Marketing Execution: By partnering with commercial operations, lead the commercial execution of product launches to ensure the launch of the best products to market. Make the product market analysis (~ 24 months before marketing). Review product launch analysis, and provide recommendations for senior management to use to maximize value for launch strategies (such as release dates, inventory building decisions, and resource decisions). Seeking and excavating potential projects, technologies and human resources matching the company's needs and establishing corresponding channels of communication;
Seeking and excavating internal project preferred outstanding collaborating companies and establishing corresponding communication channels; Responsible for business negotiations with key customers, the completion of signed cooperation agreement and track the implementation; the establishment of the United States related information channels to keep abreast of the latest US pharmaceutical industry information; technology, and talent introduction. Minimum requirements 1. Bachelor or higher degree in business or related field. MBA or equivalent preferred. 2. Working experience: At least 5 years of experience in product selection and business development experience on US generic products. Need to have experience in the US health care company, preferably injectable generic drugs, ophthalmic drugs or special drugs, and wholesalers experience related to drugs. Able to understand multi-sectoral goals, objectives, perspectives, and to identify strategies to maximize the value of the assets of the entire company. A full understanding of the US intellectual property system that enables a critical analysis of a company's product portfolio and offers recommendations to improve / strengthen strategic management. 3. Ability requirement: Proficient in MS Excel and PowerPoint, IMS and other pharmaceutical related tools. Very familiar with the US pharmaceutical and generic drugs in the field of industry structure and business processes, with integrated management and executive management capabilities..4, foreign language requirements: a good Chinese and English listening, speaking, reading, and writing skills preferred. Project Manager SUMMARY The Project Management function is responsible for managing the non-technical aspects of projects for the Generic Sterile Product Development, Manufacturing, and ANDA Submission. This includes ensuring on time and on budget delivery of projects and acting as a leadership role focal point between CMO and our technical team. This role involves managing the execution of our project requirements with CMO as per an agreed upon program of activities. Will be the key individual responsible for overall project knowledge and execution according to agreed upon deliverables and timeline. RESPONSIBILITIES: Prepare and manage project plan to meet milestones. Proactively evaluate, highlight, and escalate unresolved issues, potential barriers to project progression, and resources constraints to management. Lead meetings to facilitate project completion. Deliver projects within the agreed upon timeline and budget. Communicate project status and highlight critical path activities in a timely manner to management and Business Development. Provide notification of milestone completions for billing to finance.
Oversee and manage capital appropriated for a project to ensure funding for the project goals are obtained, spent and closed in accordance with the project plan. Communicate with supplier, vendor or contractor on project requirements and expectations. Stay current with the regulatory requirements and industry trends for project management. Write plans, engineering drawings, business correspondence, and standard operating procedures. Effectively present information and respond to questions from groups of managers, customers, and regulatory agencies in writing and verbally. Perform all foregoing applying knowledge of project management principles and concepts in a cgmp environment within the pharmaceutical industry. KNOWLEDGE/SKILLS REQUIRED: Proficient with use of technologies (e.g. Adobe Acrobat, Power Point, Gantt Chart). Strong working experience in generic product development and ANDA submissions. Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance. Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines. EDUCATIONE/EXPERIENCE: Minimum BS in a scientific discipline, Chemistry, Chemical Engineering or a related discipline. 3+ year experience in pharmaceutical project management is required, 5-7 years pharmaceutical product development and/ or manufacturing injectable experience is preferred. Sr. Regulatory Affairs Specialist/Manager SUMMARY The Sr. Regulatory Affairs Specialist/Manager is responsible for regulatory submissions and maintaining submission information in a proper RA systems. The incumbent works crossfunctionally with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labeling and artwork, ectd compilation and submission for ANDAs and NDAs registration and maintenance. RESPONSIBILITIES: Regulatory Submissions:
Works cross-functionally with internal departments and external resources (e.g., CROs, CMOs) to ensure that source documents are received in a timely manner for submissions. Prepares original ANDAs and NDAs, amendments ensuring these are in compliance with applicable FDA regulations. Performs documents formatting and publishing to ensure that submission documents adhere to FDA ectd requirements and company SOPs. Has responsibility for archiving of all original submissions in a secure system and maintains and keeps an up-to-date record of all correspondence with FDA. Labeling and Artwork: Works cross-functionally with internal departments and external resources to ensure that labeling and artwork are received, reviewed and approved in a timely manner for submissions. Prepares contents of labeling for new registration and/or revised labeling of drug products in accordance with RLD and applicable FDA regulations (e.g., 21 CFR 201 and 208). Proofreads, reviews and approves labeling printer proofs to ensure accuracy of contents, completeness and integrity. Monitors RLD labeling updates and initiates change requests, if necessary, for labeling of all new registration and marketed products in accordance with RLD. KNOWLEDGE/SKILLS REQUIRED: Proficient with use of technologies (e.g. Adobe Acrobat, ESG, XML, SPL) and ectd publishing tools. Strong working experience in Injectable ANDA, NDA ectd submissions. Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidances. Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines. EDUCATIONE/EXPERIENCE: Minimum BS in a scientific discipline, Chemistry, Chemical Engineering or a related discipline. 3+ year experience in pharmaceutical regulatory affairs is required, 5-7 years pharmaceutical product development and/ or manufacturing injectable experience is preferred. If interested, please send your resume to HR@kluspharma.com