Lab Director (Large Molecules) Job in San Diego, California Us
Client and Opportunity Description:
Our client, a provider of laboratory and diagnostic (Dx) testing services to the healthcare industry, is seeking an experienced Laboratory Director to provide direction for laboratory operations and technical conduct of biomarker and immunoanalytical projects including the interpretation, analyses, documentation, and reporting of results.
The Laboratory Director will provide direct administration of all scientific operations and lab procedures within the organization in accordance with industry (GLP) standards, contractual agreements, and regulatory commitments. The Laboratory Director will be accountable for the overall technical operations of the laboratory and the capability of the laboratory to complete the testing of pharmaceutical samples. The Laboratory Director will be responsible for the direct and indirect supervision of 15 lab personnel.
Internally, the Laboratory Director will have interaction with group leaders, project managers and other scientists. Interaction is required with bioanalytical division managers, lead personnel and scientists. Externally, the Laboratory Director will engage in interaction with clients, laboratory inspectors and visitors as well as routine contact with product and service suppliers.
Key Responsibilities:
Key responsibilities will include but are not limited to:
- Fulfilling requirements of Laboratory Director specified in applicable SOP’s
- Ensuring that adequate personnel with appropriate training and experience are able to supervise and conduct bioanalytical division work
- Staying abreast of industry technology and requirements
- Promoting innovation, operational improvements, and evaluation of new analytical technology
- Reviewing and approving laboratory SOP's
- Approving release of all validation final reports
- Approving release of all sample analysis or discovery final reports
- Ensuring laboratory operations meet regulatory requirements and client needs
- Participating in strategic planning and setting goals
- Setting operational budget including capital equipment forecast
Qualifications:
- PhD or Masters highly preferred
- 8+ years of laboratory experience is required
- Must have at least 2 years of prior management and supervisory experience including the ability to effectively lead a group of individuals to meet divisional objectives
- Basic financial aptitude including prior PL responsibilities
- Practical knowledge of bioanalytical activities, functions, and operations
- Ability to innovate and resolve problems in a timely fashion
Demonstrated Experience:
- Thorough understanding of the bioanalytical business and Ligand Binding Assay technology
- Thorough understanding of GLP and other related regulations pertaining to method validation of macromolecules, biomarkers and immunogenicity
As a professional search firm, we will only be responding to those inquiries that most closely align with the stated requirements. Moreover, our client employer can only review candidates with valid US work authorization at this time. Please include the position ID (CC 2067) in the subject line of your correspondence to ensure review and forward your credentials (*Word format please), in confidence, to: recruiter2@ccesearch.com
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