- Ensures a cGMP laboratory to meet the work demand in support of manufacturing and development work as needed.
- Provides in depth technical and scientific advice and guidance to laboratory supervisors and analysts in the Quality Control Laboratory and Operations.
- Leads and empowers a team of lab leaders to ensure the laboratory is a data factory with analysts and systems that support the sampling, testing, and generation and review of data per ALCOA principles.
- Ensures that departmental laboratory and manufacturing related investigations are completed in a timely manner.
- Ensures that the Quality Control team continues to grow technically and professionally; encourages their development efforts toward excellence and a higher degree of proficiency.
- Provides leadership by ensuring compliance of the department with laws, regulations, guidelines, procedures, and practices governing analytical Quality Control testing, including the departmental, and company Standard Operating Procedures, and safety procedures.
- Ensures that processes are in place to ensure that records and technical data are accurately maintained and results well documented.
- Represents the Quality Control department and departmental functions on projects/committees within Samsung.
- Provide support of product filings with regulatory agencies (IND, BLA MAA etc).
- Analytical and microbiological testing and release of all components, raw materials, excipients, intermediates, active pharmaceutical ingredients (APIs), finished product and stability samples, if applicable.
- Sample management, including retain and stability samples as required
- Environmental and utilities monitoring (microbiological assurance and process control).
Educations
- Bachelor’s degree in a science discipline
Required Experiences
- 10+ years industrial experience in biopharmaceutical industry, such as Biochemistry, Analytical Chemistry, Microbiology or related field, particularly in the area of assessing physiochemical characteristics of product purity, activity and functional indicators of biological products, along with 8+ years of supervisory and managerial experiences is desired
Knowledge
- Demonstrated success leading a team comprised of varying levels of technical expertise and functions.
- Strong verbal and written communication skills.
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment.
- Able to prioritise and decide appropriate course of actions. Effective at implementing decision.
- Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions
