Biochemistry Lead
LonzaGuangzhouUpdate time: August 28,2019
Job Description
Duties and Responsibilities:
- To perform QC test as required.
- Supervising the review of laboratory data (both internal and external) and the closeout of deviations.
- Scheduling of testing - coordinated with the other departments delivering samples to ensure timely delivery of results.
- Supervision of all testing techniques
- Responsible for ensuring that all personnel involved in testing are trained in basic cGMP training and are getting routine updates in cGMP information and training
- Author and review Change Controls, Deviations/Investigation as well as Test Methods,
Specifications and SOPs
- Responsible for data and logbook review
- Customer and regulatory agency interaction as required
- Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance and documentation issues are resolved
- Evaluations of vendors via vendor audits, comprehensive testing and review of quality performance
- Perform report writing (Example: Deviations/Investigations/Trending)
- Involved in equipment qualification
- Perform annual performance evaluations of all direct reports
- Provide continued coaching and developing of subordinates to help them meet both their career and personal development goals and to ensure a cohesive, productive and highly motivated team
- Any other duties as assigned by your Manager
Specific Areas of Responsibility:
Biochemistry Area:
- Supervision of all biochemical with regards to the testing of in-process, bulk release, and stability product samples. QC testing includes but is not limited to: SDS-PAGE, ELISA methods.
- Main coordination between QC testing groups and manufacturing floor personnel
Advancement to next level based on evaluation of the following:
- Demonstrated leadership within and outside direct shift responsibility.
- Make companywide contributions, relating to expenditures, budget, efficiency, etc…
- Individual should demonstrate responsible attitude appropriate to a corporate environment.
- Demonstrate solid leadership skills as well as team building and strengthening skills.
- Demonstrate solid cGMP knowledge.
- Demonstrated ability to communicate effectively in professional manner with customers.
- Performing current duties and responsibilities for a minimum of 2-3 years
Education / Experience
- Degree/Diploma in a relevant Science field or Equivalent
- 6-8 years of relevant work experience preferably Lab experience in a biotech or medically related field
- Well verse in cGMP regulations
- Knowledge area specific responsibilities
- Good problem solving and analytical skills
- Good communication skills
- Strong leadership skills
Competencies
- Decision Making
- Planning/Organizing
- Effective Communication
- Personal Orientation
- Teamwork
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