Laboratory Manager at Pharmgate Inc – Omaha, Nebraska

Job Title: Laboratory Manager

Reports To: Director of Quality Control

Department: Laboratory

Classification: Exempt, Full Time

JOB SUMMARY:

The Laboratory Manager will effectively manage the lean operation of Pharmgate’s cGMP laboratory. This position will be responsible for supervising and managing a team of quality control personnel by coordinating daily activities, providing technical support, technical and professional guidance, coaching and supervision of staff. The Lab Manager will develop and implement quality control processes, procedures and policies to ensure products meet internal and external quality standards. This position ensures that the Pharmgate Lab supports efficient manufacturing by providing compliant data supporting product quality and production operations. The Manager will also be monitoring and analyzing data to identify trends and making recommendations for improvement.

SUPERVISORY RESPONSIBILITIES:

1. Hires and trains department personnel.
2. Directs and approves the daily workflow and schedules of the department.
3. Conducts timely and constructive performance evaluations.
4. Handles discipline and termination of employees in accordance with company policy

DUTIES/RESPONSIBILIITIES:

1. Operate the laboratory in accordance with FDA current Good Manufacturing Practice (GMP) requirements and guidelines.
2. Maintain Pharmgate Standard Operating Procedures (SOPs) by utilizing professional background and accepted industry procedures and techniques in line with company policy requirements.
3. Oversee accurate and timely sample handling, analysis and evaluations.
4. Oversee accurate and timely analyses of raw materials and components to ensure they meet established quality standards.
5. Interpret analytical findings to assess compliance or non-compliance with company and industry standards. Report documented findings to department director or production management and escalate atypical results as needed.
6. Review reports of subordinates for professional acceptability and excellence. Refer corrections back to subordinates for edits/corrections.
7. Direct and coordinate the work of laboratory professionals or technicians when assigned on projects.
8. Perform and manage a team performing a broad range of chemical tests and procedures in the laboratory using professional judgement in the evaluation, selection, and adaptation of professional methods and techniques.
9. Maintain and manage all laboratory documentation, ensuring all records and reports are accurate and up to date.
10. Train team members on laboratory processes, procedures and policies.
11. Ensure compliance with federal, state, local, FDA, cGMPs organizational laws, regulations, guidelines, and best practices.
12. Ensure compliance to ensure a safe work environment.
13. Organize and participate in team meetings, representing Pharmgate’s Laboratory unit.
14. Perform laboratory department orientation and safety training for new laboratory personnel as required.
15. Lead the department in strategic planning, talent development and training.
16. Responsible for timely investigating, CAPA, and reporting results of analytical testing in compliance with quality management systems.
17. Perform other duties as assigned.

REQUIRED SKILLS/ABILITIES:

1. Thorough knowledge of Laboratory terminology, methods, and tools.
2. Working knowledge of scientific instrumentation and techniques, including direct HPLC experience and troubleshooting.
3. Thorough understanding of FDA, cGMP compliance regulations.
4. Working knowledge of Regulatory, CGMP and FDA regulations as required to ensure Pharmgate products and production units meet internal and external quality standards.
5. Ability to work collaboratively and communicate effectively.
6. Strong analytical skills, verbal and written communication abilities.
7. Skills in utilizing organization and time management to effectively manage multiple priorities daily.
8. Valid driver’s license.

PREFERRED SKILLS/ABILITIES:

1. Proficient with virtual meeting applications, SAP Business One, Master Control, or other related software.
2. Proficient with Microsoft Office Suite, including but not limited to basic spreadsheet functions and word processing.

EDUCATION AND EXPERIENCE:

1. Bachelor of Science degree in Chemistry, Microbiology or Biology.
2. Minimum ten (10) years’ experience in the industry with an emphasis on quality control testing and chemical laboratory experience; preferably in a pharmaceutical production facility.
3. Five (5) years of experience as a supervisor, manager, or similar relevant position.

PHYSICAL REQUIREMENTS:

1. Prolonged periods of standing and walking through the facility.
2. Prolonged periods of sitting at a desk working on computers.
3. Must be able to occasionally lift 55 pounds from floor to waist level.
4. Visual acuity to inspect products and machinery.
5. Ability to occasionally climb stairs.

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.