Manager Labs, Pharma

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Standard (Mon-Fri)Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJoin Us as а Senior Manager, Clinical Lab Scientist - Make an Impact at the Forefront of InnovationThe Senior Manager, Clinical Lab Scientist supervises and assists group leaders, scientists, and medical technologists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. This role plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Additionally, the Senior Manager assists the division director in strategic planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.What You'll Do: Interact with clients and business development on requests for proposals and project definition. Prepare, review and approve bids and proposals, scope of work and pricing. Negotiate with clients on timelines and pricing. Manage/direct work responsibilities of group leaders as well as prioritize talks and resources. Review data for technical quality and compliance to protocols, methods and SOPs. Review and approves laboratory investigation, deviations, and QA facility and data audits. Lead client and regulatory audits. Prepare and update revenue projection reports, review Partner and timesheet reports for revenue recognition and billing, evaluate resource utilization reports and project profitability. Review and approve study protocols, project status reports, final study reports and other project related technical documentation. Assist in technical sales and marketing, prepare technical marketing materials, and participate in poster and podium presentations in technical conferences. Assist upper management in strategic planning, budgeting, new capabilities development and other responsibilities. Prepare and implement SOPs and company operational policies. Ensure adherence and makes recommendations to quality system improvements.Education & Experience Requirements: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience. 5+ years of management responsibility Proven leadership skillsIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance Proven technical troubleshooting analytical instrumentation and problem solving abilities Excellent written and oral communication skills Project and time management skills Ability to implement quality systems and process improvements Ability to provide guidance to clients on analytical issues and regulatory requirements Knowledge of budgeting, forecasting and fiscal management Demonstrated coaching and mentoring skills Demonstrated strategic planning skills Strong organizational agility and demonstrated drive for results.Working Conditions and Environment: Work is performed in an office and/or laboratory and/or clinic environment with exposure to electrical office equipment. Frequently drives to site locations, frequently travels within the United States, occasional international travel. Rare exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. Personal protective equipment required in frequently such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions.
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