Director Chemistry Operations

at  WuXi AppTec Inc

Overview:
The Director will provide planning, supervision, management, leadership, scheduling and financial oversight to the daily lab operation of the Analytical Chemistry Department in Germany. He/She will have a strong science background, the ability to manage laboratory workflow efficiently, good attention to detail and experience in Good Manufacturing Practices (cGMP) environments. In addition, this individual should have the ability to work effectively in a cross functional team-based environment and work independently. This position will have direct oversight of the technical operations group and dotted line oversight to the quality group and the business operations group.

Responsibilities:

• Supervise the Analytical chemistry management team and staff, coordinate and have primary responsibility for the daily operations of the laboratories.
• Interact as needed with external and internal clients in activities including but not limited to audits, inspections and site visits.
• Ensure testing and reporting of results are conducted in a timely and accurate manner.
• Ensure laboratories are appropriately equipped and staffed for projected test volumes. Provide information for capacity planning and capital expenditures (capex).
• Works with Quality organization to initiate, investigate, approve and close deviations, laboratory investigations, CAPAs and other issues relating to compliance as needed.
• Work with business operations group to understand cost models, pricing structures, technical study requirements, client complaints, new test offerings, client experience.
• Responsible for ensuring team members understand program objectives, deliverables and timelines through consistent and clear communication, leadership and client advocacy.
• Provide insight to new business opportunities. Oversee the development and implementation of new test methods based on new business needs.
• Responsible for the management of expenses (staff, equipment, supplies, etc.) in order to meet the budgeted financial expectations of the analytical chemistry laboratories.
• Responsible for the development, review and evaluation of performance metrics, and corrective and preventative actions to ensure process improvement goals.
• Identifies issues or challenges which may delay programs and make recommendations as to appropriate mitigation of risk, strategies and actions to ensure program progress.
• Contribute and participate in strategic planning, business planning and development of management processes for the Analytical Chemistry Department.
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the creation and achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments

Qualifications:

Experience / Education

• Minimum of 5 years of relevant management experience or equivalent
• Bachelors’ degree in Life Sciences or other medical related field or equivalent experience

KNOWLEDGE / SKILLS / ABILITIES:

• Minimum of 2 years direct experience in analytical chemistry laboratory operations
• Experience in coordinating complex programs across functional groups
• Good planning, resource management and project management skills
• Experience in working within a contract manufacturing or contract services organization preferred
• Proficient in Oral & Written communication skills
• Proficient in German Required
• Need to be able to speak, read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

PHYSICAL REQUIREMENTS:

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 25 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 50 lbs occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs
• Ability to work in variable temperatures high to freezing
• Inside working conditions

AN EQUAL OPPORTUNITY EMPLOYER. ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY, NATIONAL ORIGIN, OR PROTECTED VETERAN STATUS AND WILL NOT BE DISCRIMINATED AGAINST ON THE BASIS OF DISABILITY

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management

• Supervise the Analytical chemistry management team and staff, coordinate and have primary responsibility for the daily operations of the laboratories.
• Interact as needed with external and internal clients in activities including but not limited to audits, inspections and site visits.
• Ensure testing and reporting of results are conducted in a timely and accurate manner.
• Ensure laboratories are appropriately equipped and staffed for projected test volumes. Provide information for capacity planning and capital expenditures (capex).
• Works with Quality organization to initiate, investigate, approve and close deviations, laboratory investigations, CAPAs and other issues relating to compliance as needed.
• Work with business operations group to understand cost models, pricing structures, technical study requirements, client complaints, new test offerings, client experience.
• Responsible for ensuring team members understand program objectives, deliverables and timelines through consistent and clear communication, leadership and client advocacy.
• Provide insight to new business opportunities. Oversee the development and implementation of new test methods based on new business needs.
• Responsible for the management of expenses (staff, equipment, supplies, etc.) in order to meet the budgeted financial expectations of the analytical chemistry laboratories.
• Responsible for the development, review and evaluation of performance metrics, and corrective and preventative actions to ensure process improvement goals.
• Identifies issues or challenges which may delay programs and make recommendations as to appropriate mitigation of risk, strategies and actions to ensure program progress.
• Contribute and participate in strategic planning, business planning and development of management processes for the Analytical Chemistry Department.
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the creation and achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other department