Supervises a business unit consisting of one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Environmental Monitoring, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, Laboratory Continuous Improvement/ Compliance Operations, Stability, Validation and support Regulatory Submissions.
- Supervise a team and is responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level or performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem-solving. Identify and resolve people issues without direct supervison.
- Assure conformance to all government and corporate regulations. Responsible to develop, provide, defend, persuade Corporate/Plant practuces with outside organizations. Routinely meet with regulators (FDA & EU) and customers to ensure no interruption in business due to compliance issues.
- Directs area of responsibility to meet production objectives within planned budgets. Provides unput to Supervisor for resources needed to construct budget, updates, and changes in financial plan. Supervises area supplies and equipment within budgeted amounts.
- Establish and execute plans and commitments consistend to Development, Manufacturing, Customers and Business needs.
- Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, Continuous Improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility.
- Applies advanced technical writing skills to prepare project protocol, and final reports to support registration and/or business needs.
- Conducts business and interacts/negotiates with external contacts and customers to develop positive business relationships.
- Required - BS Degree in Science or equivalent
- 8+ years of relevant experience
- <3 years of Supervisory experience
- Must be experienced and demonstrate high level of technical skill in technical lab operations and good understanding of related business.
- Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required
- Ability to work independently to meet operational goals and business needs
- Ability to make operational and business decisions with minimum direction from immediate supervisor. Must have knowledge and skill in personnel supervision and develop and manage budget.
- Ability to interact and establish positive interaction with internal/external customers
- Show broad understanding of the issues relevant to technical/science and business
Development, Manufacturing, Quality and Regulatory
Significant Work Activities: N/A
Job Type: Experienced