Technical Director – Laboratory Analytical Services

position title:

Technical Director

DEPARTMENT:

Operations

reports to:

Vice President of Operations

position summary:

To provide overall technical leadership for laboratory services by developing, implementing, and maintaining all technical aspects of chemistry and microbiology departments. To obtain total client satisfaction, optimum efficiency, economy of operations, safe work environment, while maximizing profits. Responsibilities include client interfacing, training, review and analysis of out of specification reports, method validation and verification, new project start-up, and project cost estimation for laboratory services.

essential functions:

    Out of Specification (OOS) Review

§         Responsible for initiation and management of OOS investigations for all client inquiries and complaints. (P)

§         Determine root cause of the issue and consult with key resources for corrective actions. (P)

§         Keep executive management informed and updated on improvements made to ensure root causes are corrected. (P)

§         Ensure client is notified of the outcome and responsible for providing the final written OOS report to the client. (P)

    Client Interfacing

§         Identify improvement opportunities as it relates to better work practices through efficiency and high quality to increase client satisfaction. (S)

§         Promote value-added technical knowledge to exceed client expectations. This requires representing technical capabilities via phone, written communication, and face-to-face with all clients served both on-site and off-site. (P)

§         Presenting technical progress and programs to our clients to enhance our relationship and reputation with them. (P)

    Method Verification and Validation

§         Research, and ultimately approve method validation and verification procedures on USP and NF methods requested by clients (P)

§         Supports method transfer, optimization, and validation in support of both chemistry and microbiology labs (S)

§         Utilize technical knowledge in understanding variety of analytical methods which might include researching projects via internet. (P)

    Training

§         Ensures that the training program for all associates is appropriate so the associate may perform necessary technical analytical lab responsibilities (S)

§         Verifies and Validates associates execute lab responsibilities consistent with company quality standards and procedures. (Quality job)

§         Supports the Quality Assurance/Control department in ensuring all necessary technical training programs are in compliance and Standard Operating Procedures are being followed. (S)

    Project Cost and Estimation

§         Coordinates activities and provides input on client request cost estimates for all laboratory service requests submitted through client service department. (P)

§         Leverages necessary associates in providing input for the client project requests (P)

§         Seeks additional input from both client service department and client to ensure the requirements are fully understood. (P)

§         Provides comprehensive estimate to the client in a timely manner. (P)

    Project Start-Up

§         Provides necessary technical expertise for new projects and supports the development of a comprehensive process mapping. (P)

§         Develops work instruction, training plan, flow charts, method qualifications, and equipment needs for new project start-up. (S)

§         Acts as a technical liaison in interfacing with the client through the transition of the work moving from being managed by the client to being managed by ATL. (P)

Experience, Competencies, and Education:

·        Strong knowledge of compendia and laboratory techniques preferably in the area of pharmaceutical or consumer product industries. Including familiarity with cGMP and GLP.

·        Strong working knowledge of USP-NF methods.

·        Strong interpersonal skills such as communication, relationship building, leadership, initiative, adaptable, positive attitude, and team building.

·        Ability to develop technical plans and programs to ensure a efficient, safe, high quality laboratory operation.

·        Ability to apply and adapt practices and techniques to the special requirements of senior management.

·        Ability to establish and maintain effective relationships with clients, executive team, other management staff, and laboratory associates.

·        Ability to work independently, self motivated and strong attention to detail

·        Ability to present facts and recommendations effectively in oral and written form.

·        Minimum of 10 years industrial experience in pharmaceutical or consumer products

·        PhD or Master’s degree in Chemistry