Senior Laboratory Manager
- Job Title
- Senior Laboratory Manager
- Job ID
- 27680222
- Location
- Clearwater, FL 33760
- Other Location
- Description
-
WHY CORERX?
CoreRx is a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx, our biggest asset is our people, and the service and solutions they provide to our partners; you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.Our employees enjoy a competitive benefits package, including:
- Competitive compensation with an annual discretionary incentive bonus!
- Affordable healthcare insurance (Medical, Dental, Vision)
- Health Care Flexible Spending Account
- Employer paid LTD, STD, and Life Insurance coverage.
- Paid Time Off (PTO), 15 days pro-rated your first year + 10 Paid Holidays.
- 401k with 3% employer match
- Tuition Reimbursement, Perks at Work Employee Discounts, Employee Assistance Program, and Adoption Assistance Program.
• Ability to manage laboratory operations.
• Ability to work in a highly dynamic environment including working with and through others to accomplish goals.
• Knowledge/expertise in small molecule drug product testing including instrumentation and analytical method transfer/validation.
• Experience participating in change management efforts in support of a dynamic business.
• Knowledge of US and EU regulatory requirements with respect to quality control and experience participating in regulatory inspections.
• Experience in all aspects of GMP laboratory management.
• Expertise in review and approval of analytical test results, controlled documents, and validation protocols/reports.
• Strong interpersonal, written, and oral communication skills.
• Excellent organizational and time management skills.
• Proficient in Microsoft Office Suite
• Minimum of 10 years’ experience in an FDA-regulated pharmaceutical environment
• Minimum of 2 years’ experience in Management role; prefer experience in GMP laboratory
RESPONSIBILITIES
• Ensures compliance and business deliverables are met;
• Oversees on-time delivery of raw materials, in-process samples and finished products.
• Responsible for tracking and trending key performance indicators and metrics.
• Oversees laboratory compliance and manage the efficiency of operations and continuous improvement activities.
• Provides mentoring and career development to team members.
• Participates in projects to support analytical deliverables.
• Provides expert technical analysis and evaluation of analytical issues to the analytical team and to clients;
• Interacts with clients during all phases of projects (i.e. early phase clinical through commercial)
• Performs other duties as assigned.
ADDITIONAL QUALIFICATIONS:- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Vision suitable for performing detailed inspections
- May be required to move items weighing up to 25 lb.
- While performing the duties of this job, the employee is regularly required to talk and hear.
- The employee may be performing work in multiple buildings on the campus and is required to stand and walk.
- The employee will be required to focus on reading/evaluating documents and expected to have great attention to detail.
Job Type: Full-time
Notification to Agencies: Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.