Laboratory Manager jobs in Frisco, TX

Affiliated with Medisca, CED Laboratory is looking to fill the role of Laboratory Manager. The Laboratory Manager is to take responsibility for running the pharmaceutical laboratory. This includes the management of contractual operations, maintenance and progression of the laboratory’s quality systems, maintenance of the health and safety program as well as laboratory budgetary responsibilities. You will manage a scientific staff and be accountable to ensure that work is processed in a timely fashion whilst adhering to the prerequisite quality standards expected by CED Analytical Labs.

Your key responsibilities:

Laboratory Operation

• Coordinate laboratory operations based on priorities and customer’s requirements.
• Plan and establish schedules and follow-up against turnaround time estimates.
• Provide direction and delegation of responsibilities to staff.
• Enforce all Laboratory procedures and answer staff questions about policies and procedures.
• Provide subject matter expertise in resolving day-to-day technical issues within the laboratory.
• Keep abreast of changes to relevant regulatory and company requirements and contribute to the progression of the laboratory quality systems.
• Communicate with clients about procedures to assure the Laboratory is correctly interpreting testing requests.
• Maintain a high level of competency in the use of the laboratories LIMS & data handling systems to effectively manage workflow & monitor performance.
• Personnel Development
• Manage Lab Training Program
• Investigate analyst errors, laboratory issues, and out of specification data.
• Evaluate work performed by staff and re-train staff where necessary.
• Conduct performance appraisals, coaching, disciplinary documents, etc.
• Coach staff to improve testing technique, accuracy, and efficiency.

Equipment and Instrumentation

• Maintain schedule and timely inspection/calibration of instrumentation.
• Analyze equipment data and ensure that all data generated from the laboratory maintains its integrity.
• Purchase chemical inventory and monitor cost and supplier selection.

Health & Safety

• Direct and administer institutional chemical and biological safety programs to assure compliance with regulations related to the safe handling and use of biological materials and chemical agents.
• Oversee development and management of waste/EPA programs, including hazardous chemicals and controlled substances.
• Oversee development and implementation of chemical, biological, and environmental management training, policies, procedures to ensure compliance with appropriate regulations.
• Prepare reports for management about Laboratory information and recommendations as necessary.
• Perform other duties as assigned.

Travel:

Up to two (2) weeks per year to Medisca head office in Montreal, Quebec.

Skills, knowledge and abilities:

• B.Sc./M.Sc. in Chemistry or a Science related field
• Five (5) years’ experience managing a team in a lab setting.
• Six (6) years’ relevant life science experience and/or training in pharmaceutical testing; or equivalent combination of education and experience
• Proven experience with analytical method acquisition, qualification, transfer and validation for the analysis of raw materials, chemical intermediates, and final products that support API manufacturing.
• Proven experience with establishing Standard Operating Procedures and contributing to quality incident (deviations, investigations) resolutions.
• Ability to successfully manage multiple projects to completion, including implementation of LIMS
• Ability to strategically operate multiple instrument technologies (e.g. LC-MS, HPLC, GC-FID, ICP-MS, UV-VIS, IR, etc.)
• Working knowledge of cGMP/GLP, ICH, USP/NF, FDA regulations, Laboratory Investigation practices, and method development/validation.
• Strong work ethic and reliable
• Excellent time management and organizational skills
• Able to work under pressure and successfully function in a fast-paced environment
• Excellent communications skills; fluent English (oral & written) required
• Knowledge of Microsoft Office suite (Word, Outlook and Excel) required

What’s In It For You …

We invest time and resources into making sure Medisca is as good as the people we hire.

• Balance Your Life – PTO, vacation policy and paid statutory holidays
• Invest in your health – Group Benefit plan and health savings account
• Your Future is Bright – Opportunities to learn and grow within CED
• Save for your Future – 401k plan retirement
• Help us grow – Employee Referral Program
• We like to have fun – company events throughout the year

We invest time and resources into making sure Medisca is as good as the people we hire.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.

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