At AsymBio, we know that our employees are the cornerstone of our success. We believe in innovation, collaboration and that our client comes first. We are a team from different countries, backgrounds and cultures with the same goal in mind – providing superb drug manufacturing and development services to pharmaceutical and biotech companies world-wide. We offer rewarding careers, comprehensive benefits, opportunities to grow and the ability to be a part of something big.
Job Title: Analytical Scientist of Analytical Development
We’re sincerely looking for a highly motivated, enthusiastic candidate who is willing to engage in ADC or bioconjugate analysis to conduct effective & productive experimental programs to support our Boston process development and manufacturing teams. In addition, the selected candidate would be responsible for ensuring that communications with the customer are transparent and effective, as well as effectively managed projects, particularly with respect to project timeline, budget and data transmission.
Primary Responsibilities:
• Accountable for the analytical method development and testing for all assigned projects. The main responsibilities include assigning tasks to junior staff (where appropriate), deliver method development report and testing report to process development team or clients. Troubleshooting technical problems and providing solutions to technical issues occurred during development and/or manufacturing. Leading client meetings and ensuring timelines and budgets are met.
• This position will require the selected candidate to:
Ø Display expertise in physicochemical analytical techniques, including chromatography, mass spectrometry, spectroscopy, electrophoresis, to provide sufficient analytical support during project execution.
Ø Manage and maintain state-of-the-art analytical laboratory, including installation, qualification/calibration and maintenance of analytical instruments; management of reagents, reference standard and samples to comply quality requirements.
Ø Lead and ensure all analytical method development and testing activities in compliance with regulatory requirements.
Ø Responsible for developing analytical strategies to maximize the capability and efficiency of the analytical setup, address unmet needs in LC and LC-MS workflow including sample preparation method
Ø Lead analytical method transfer from customers, or to other sites of Asymchem, in compliance with ICH and pharmacopeia requirements.
Ø Responsible for technical documents such as analytical method SOP, validation / transfer protocols and reports.
Ø Lead trouble shooting, optimization and implementation of challenging and innovative LC and MS assays for antibody drug conjugate (ADC) and other bio-conjugates, participate in investigation teams and provide analytical input for problem solving during process development.
Ø Ensure appropriate safety procedures are followed, maintain good EHS and 5S status for analytical laboratory.
Ø Ensure data integrity in laboratory, ensure all data is effectively shared with customers as appropriate.
Ø Ensuring that the scientists assigned to the project are sufficiently experienced and competent, plan and deliver appropriate training to the scientists, contribute to continuously enhancement of knowledge and skills of scientist, as well as performance reviews.
Ø Manage multiple projects and liaise with both customers and internal stakeholders (process development, quality, regulatory affairs, QC, etc.), ensure all analytical activities are executed and meet project timeline and budget.
Ø Provide technique support to business development (BD) colleagues in communication with prospective clients, such as quote and new order discussion.
Qualifications:
• Ph.D. in analytical chemistry, biological chemistry, biological pharmaceutics, or other related scientific field with at least 5 years of protein analysis related industry experience, or Master’s degree and 8 years of relevant experience.
• Experience of analytical method development of chromatography (e.g. SEC, IEX, HIC, RP, etc.), and mass spectrometry (LC-MS), capillary electrophoresis (e.g. r CE, nr CE, icIEF), for monoclonal antibody and ADC.
• Experience troubleshooting and maintaining instrumentation such as liquid chromatography and Q-TOFs
• Experienced with protein analytical skills (physicochemical) and knowledge about antibody/ADC analysis is highly preferred.
• Independent researcher; strong problem solving and troubleshooting capabilities; proactive and self-motivated; good at multi-tasking.
• Experience and knowledge of cGMP compliance, and the relevant ICH quality guidelines, along with understanding of the requirements for analytical method qualification at different phases of clinical development (pre-clinical, phases I-IV).
• Experience in project management, capable to independently plan, organize and manage multiple projects.
• Excellent oral and written communication skills for effectively communication internally and externally.
To apply for job opportunities - asymcnbiohr@asymchem.com.cn
