Laboratory Manager

SUMMARY/OBJECTIVE:

This position is responsible for the hands-on management of all laboratory activities, from raw material testing to finished product release. You will play a key role in ensuring that all analytical testing is conducted in compliance with cGMP, FDA, and ICH guidelines, while also overseeing the method development, validation, and troubleshooting of analytical techniques. In this diverse and fast-paced role, you’ll lead a small but dedicated team of analysts, working closely with cross-functional teams to ensure the highest quality products are delivered on time. This position interfaces with customers providing expert advice on the development and validation of analytical methods.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead daily analytical operations in a hands-on capacity, including testing of raw materials, in-process samples, finished products, and stability studies.
• Develop, validate, and troubleshoot analytical methods (HPLC, GC, UV-Vis, FTIR, dissolution) in collaboration with PDE and manufacturing, ensuring them phase appropriately.
• Review and approve analytical data and documentation, ensuring it meets regulatory standards and quality requirements. Document findings in line with Good Documentation Practices (GDP).
• Manage investigations into OOS, OOT, deviations, and CAPAs, providing scientific rationale and resolution in a timely manner.
• Maintain cGMP compliance, ensuring laboratory practices adhere to current Good Manufacturing Practices and regulatory requirements.
• Coordinate the qualification, calibration, and maintenance of laboratory equipment to ensure they remain fully functional and compliant with industry standards.
• Create, review, and update SOPs, test protocols, and work instructions, maintaining up-to-date documentation for laboratory processes.
• Mentor and train laboratory staff, ensuring team members are continuously improving their technical skills and adhering to quality and safety standards.
• Liaise with cross-functional teams (Manufacturing, QA, PDE, BD) to ensure seamless communication and efficient resolution of issues.
• Support regulatory inspections and audits by preparing technical documentation and acting as the subject matter expert for analytical testing.
• Manage laboratory inventory and procurement, ensuring timely availability of all necessary reagents, standards, and equipment.
• Promote a continuous improvement culture, identifying areas for operational efficiency, and implementing practical solutions to enhance laboratory performance.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree in chemistry or relevant field with a minimum of 10 years of analytical laboratory or relevant experience.
• A PhD with greater than 6 years of analytical specific experience.
• At least 3 years of experience with HPLC method development.
• Strong expertise in analytical techniques such as HPLC, GC, UV-Vis, FTIR, dissolution, and wet chemistry.
• Comprehensive understanding of cGMP and regulatory guidelines (FDA, ICH, USP).
• Proven ability to troubleshoot analytical instrumentation and resolve technical issues.
• Solid experience in method development, validation, and transfer.
• Excellent leadership, communication, and organizational skills.
• Strong problem-solving abilities with a focus on detail and accuracy.
• Experience with laboratory data systems.

COMPETENCIES/SKILLS:

• Excellent written and verbal communication skills with ability to give internal and external presentations.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software.
• Excellent organizational and communication skills.
• Read and interpret documents such as standard operating procedures, manuals, experimental protocols, and analytical methods.
• Legible Handwriting
• Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.
• Communicate with clients on topics such as method development, data interpretation, and investigations.
• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.

SUPERVISORY RESPONSIBILITIES:

Yes

WORK ENVIRONMENT:

This job operates in an office/lab setting.

PHYSICAL DEMANDS:

• 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must have the ability to receive detailed information through oral communication.
• Standing/remaining upright on the feet for extended periods of time.
• Walking/moving about on feet to accomplish tasks frequently within the facility (Laboratory, Production, Warehouse, etc.)
• Capable of lifting 50 lbs. occasionally preferred.
• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

Travel will be required less than 10% of the time, domestic and international.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.