天津招聘

JOB DESCRIPTION

Your working location is at Shanghai or Beijing, China.

Your day to day responsibilityas Analytical R&D director is to lead analytical and/or stability services programs and providing support to formulation development, and clinical trial material manufacturing. You should have extensive scientific/technical expertise and experience in drug product development (e.g. analytical development for API or/and formulated products, stability study, ICH guidelines, CMC & regulatory filing, and GMP compliance) appropriate for the level of decision making the job requires.

JOB REQUIREMENTS

To be successful a doctor degree in Analytical Chemistry or equivalent with 10+ years industrial experience in pharmaceutical analysis is required - all aspects of drug substance and/or drug product analysis and characterization experience is necessary. Experience in a cGMP laboratory is required. 3+ years of experience managing groups. Familiar with EHS/DEA regulations and ICH and FDA guidance. Experience in completing the analytical aspects of IND/NDA/ANDA submissions. Ability to communicate effectively in both English and Chinese, make presentations and write concise reports for senior management and clients.

SPECIFIC ACTIVITIES:

· Responsible for the overall operation and administration of the R&D Laboratory, including assessment and hiring of personnel, recordkeeping and reporting test results promptly, accurately, proficiently and assuring compliance with the applicable regulations.

· Direct, coordinate and prioritize analytical scientists and other technical staff responsible for providing analytical support for the testing of new drug substances, excipients, pre-formulation samples and formulation development samples. Providing training, technical expertise and support to the staff.

· Direct activities relating to methods development, methods validation, and tech transfer.

· Review and approve laboratory reports, methods and procedures.

· Ensure that departmental goals are met and report progress to senior management. Working independently and exercises appropriate judgment.

Frontage CMC, Integrated Drug Product Development Service

Established in 2001, Frontage is a leading global pharmaceutical and biopharmaceutical, outsourcing company with operations in China and the United States. As a solution-driven and customer-focused company, Frontage provides a broad and integrated portfolio of services throughout the drug product development process. Our services are designed to help our worldwide customers shorten the development time and lower the cost of drug development through cost-effective and efficient outsourcing services.

方达医药全球型全方位新药研发外包服务公司（CRO）,于2001年成立于美国，总部位于宾夕法尼亚州费城西郊的埃克斯顿。2006年成立方达医药技术（上海）有限公司，在苏州和郑州分别设有分公司和管理团队。2019年5月30日，方达控股（方达医药上市主体）成功登陆香港联交所主板，股票代码*******。

方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。

● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。

您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************