Manager, Chemistry

Responsibilities

• Directs and prioritizes the functioning of multiple laboratory work teams within the department to provide for the timely and accurate testing of raw materials, in-process and finished goods, to demonstrate that product meets FK USA and FDA regulatory quality requirements.
• Oversees the administration of staff to ensure that members are adequately trained, developed and motivated, and that they adhere to quality performance standards.
• Plans and coordinates training schemes leading to the development of cross-trained, self-directed work teams in line with total quality management concepts.
• Stays current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
• Evaluates and decides upon corrective actions to be taken in response to OOS or OOT situations.
• Provides evaluation and quality control recommendations for new processes relevant to chemistry concerns or to troubleshoot existing processes.
• Aids in the development, administration and maintenance of the operating and capital budgets for the department.
• Represents the department with active participation in cGMP inspections and other audits as required.
• Collaborates with departmental staff to ensure all departmental obligations conform to cGMP and FK USA policies and procedures.
• Provides assistance to the organization within areas of expertise as needed.
• Participates in the review of annual product review documents related to the department.
• Attends and represents the department at the applicable management review meetings.
• Works with peers within the site and/or at other sites to develop and harmonize processes and procedures to improve/enhance the compliance, capability, and capacity.
• Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
• Ensures compliance to Occupational Health and Safety is met under ISO 45001.

Qualifications

• Bachelor's degree in Chemistry or related field.
• Minimum of 5 years of experience in a similar position, preferably in a pharmaceutical or biotechnology setting.
• Experience with cGMP regulations and Good Laboratory Practices (GLP).
• Knowledge of analytical chemistry techniques and methods.
• Strong organizational and leadership skills.
• Ability to work independently and as part of a team.
• Excellent communication and problem-solving skills.