职位描述
POSITION SUMMARY
Reporting to R&D Associate Director, the Staff Scientist will work in Analytical Chemistry lab to support qualification and registration of Pharmaceutical Systems (PS) products and provide technical services to customers in China.
KEY RESPONSIBILITIES
- Apply existing methods and develop new methods to investigate compatibility between drugs and containers/packaging materials, contributing to regulatory submissions, analytical services for customers and complaints handling.
- Design and conduct analysis on extractable for raw PFS components and leachable in stability of drug samples and drug products using UPLC/MS, GC/MS/FID, ICP-MS and various analytical methods.
- Keep close communication with global R&D labs to ensure the test method synchronization.
- Establish stability test project plans. Execute experiment plan, interpret data, and generate scientific reports. And perform technical and quality risk assessments.
- Test method development, verification and validation, method translation. Develop proper methods for leachable target in drug products. Unknown peak identification and quantitation.
- Anticipate, recognize and resolve complex technical issues through job knowledge, use of technical resources including technical literature and experts and well formulated, logical experimentation. Solutions require creativity, critical thinking, and collaboration, considering a broad range of potential impacts, including those that are downstream.
- Provide guidance (scientific and administrative) for analytical scientists. Direct activities as well as provide training and coach for others.
- Support laboratory management, operation, documentation, safety, instruments maintenance, and sample/reagent management to meet the quality and regulatory compliance.
- Work with other functions such as QA, EHS, Procurement and Supply Chain.
- Work with 3rd party labs for sample analysis when needed.
- Participate in the innovation process with regard to creating new design ideas and solutions.
- ORGANIZATIONAL MANAGEMENT/ DEVELOPMENT AND LEADERSHIP
o Innovation: Develop and apply innovative approaches to ensure best outcomes in all aspects of the role. Create an environment in which innovation can flourish through empowerment, encouragement, and support.
o Customer focus: Individually and for the design group, develop advanced understanding of external and internal customers to effectively improve design and quality of products.
o Accountability: Demonstrate strong and clear accountability for individual and direct reports’ performance and delivery.
o R&D communication: Conduct and encourage frequent formal and informal communication within the group to ensure full engagement and efficient operation.
o Influence others: Intuitively and quickly assess people and situations and act accordingly. Demonstrate strong persuasion and timing skills. Remain open to be persuaded when appropriate.
o Inclusive work environment: Promote and leverage diversity to achieve best outcomes. Ensure all interested parties have opportunities to influence and contribute to decisions and outcomes.
o Leadership courage: Demonstrate and promote leadership courage by doing what is right. Engage those who disagree to persuade or be persuaded. Instill confidence in associates and customers.
o Dealing with ambiguity: Demonstrate agility and action orientation when facing change and uncertainty. Effectively manage change and instill confidence.
REQUIRED SKILLS AND ABILITIES
- At least Bachelor's degree in Pharmaceutics, Pharmacy, Chemistry, Chemical Engineering or related discipline with at least 8 years of relevant experience.
- In-depth knowledge and extensive hands-on experience with method development for LC/MS, GC/MS and ICP-MS.
- Must have extensive experience with method validation and transfers for analytical methods according to current regulatory and pharmacopeia guidelines.
- Knowledge of drug packaging materials of glass, rubber and plastics.
- Be familiar with CHP, YBB, GB, USP, EP, ICH etc.
- At least three years of experience in chemical laboratory under ISO17025/GLP/GMP quality system.
- Knowledge of Material Data Sheets, Laboratory Safety Procedures, and Personal Protective Equipment (PPE).
- Ability to work well with a wide range of functional groups including R&D, QC, QA, Regulatory Affairs, and Commercial Operations.
- Excellent communication (oral and written) and interpersonal skills in order to interface with global R&D groups, global manufacturing plants and regulatory teams.
- Excellent oral and written English skill.
- Be careful and conscientious; be initiative, independent, good communication and team collaboration.
DESIRABLE
- Master or PhD is a plus.
- Experience in E&L study highly desirable.
- Strong creative ability and advanced technical judgment.
