Sr. Manager, Metrology

Alcami-5; Morrisville (NC); On-site; USD 120,000 - 155,000; Full time

Job summary

Alcami is seeking a Senior Manager of Metrology to lead the metrology group responsible for calibration, diagnostics, repair, maintenance and qualification of laboratory instrumentation. You will develop production plans to meet safety, quality, output and cost goals, and approve metrology documentation and SOPs.

The role requires strong leadership, mentoring capabilities, and ability to train staff, with on-site work and travel up to 10%.

Qualifications

• Bachelor’s degree in Life Science, Engineering or Electronics with 8+ years pharma experience.
• Minimum 4+ years in supervisory roles.
• Strong knowledge of cGMP and ISO17025 calibration standards preferred.

Responsibilities

• Lead metrology department to optimize equipment qualification.
• Review and revise SOPs and metrology plans.
• Develop procedures and training modules for staff.
• Ensure compliance with cGMP and regulatory requirements.
• Manage audits with clients and regulators.

Skills

Quality assurance reviews

cGMP knowledge

GMP environment

Pro Cal

Communication skills

Electronic circuits

MS Office

Excel

Word

Training & mentoring

Education

Bachelor’s degree in Life Science, Engineering or Electronics

Tools

Pro Cal

Job description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary

The Senior Manager of Metrology is accountable for driving results in a fast-paced environment by supervising the daily activities of the Metrology group that performs calibrations, diagnostics, repair, maintenance and equipment qualification of laboratory analytical instrumentation such as HPLC and gas chromatography. The ideal candidate will develop production and resource plans that meet production goals in terms of safety, quality, output, cost and financial savings for the Company. The Senior Manager of Metrology will complete and review calibration documentation and the work of the Metrology team.

The Sr. Manager, Metrology is accountable for driving results in a fast-paced environment by supporting general pharmaceutical metrology activities. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and metrology master plans; supporting facility, utility, manufacturing equipment, and laboratory instrument metrology efforts; conducting reviews of metrology documentation such as metrology plans, system/functional requirements, protocols and summary reports. The position requires strong leadership behaviors and the ability to train and mentor staff.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Leads the metrolgoy department to optimize the qualification of equipment and systems.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Maintains all documentation pertaining to qualification and metrology.
• Develops procedures and/or protocols.
• Leads investigations as needed.
• Develops team metrics, and ensures monthly goals are met.
• Serves as information resource for other metrology personnel, contractors and vendors.
• Executes and oversees procedures and/or protocols.
• Drafts and approves department SOP’s and training modules.
• Reviews, composes/revises SOP’s
• Owns the laboratory equipment requalification program and compliance to the program.
• Acts as a certified trainer for applicable training
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Represent Alcami in audits (both client and regulatory) regarding metrology related questions.
• Maintains the monitoring system for stability chambers and laboratory incubators.
• Ensures adherence to personnel and equipment SOPs and other regulatory requirements.
• Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run projects and repeat of work.
• Develops and executes strategies to improve productivity.
• Develops and executes work plans/schedules, using production milestones and division/site performance standards and metrics.
• Monitors the progress against the timeline.
• Provides troubleshooting support as needed.
• Monitors the quality of the group.
• Effectively communicates with clients and internal groups.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications

• Requires a related Bachelor’s degree in Life Science, Engineering or Electronics with 8+years of relevant experience within the Pharmaceutical Industry.
• Must have at least 4+ years of experience in supervisory roles.

Knowledge, Skills, and Abilities

• Excellent knowledge of quality assurance reviews of metrology and validations documentation.
• cGMP training and excellent understanding of requirements.
• Excellent knowledge of pharmaceutical GMP environment.
• Excellent understanding of and ability to utilize Pro Cal.
• Excellent verbal and written communication skills.
• Excellent understanding of circuits, components, analytical equipment and instrumentation for laboratory and manufacturing equipment.
• Excellent working knowledge of Microsoft Office applications.
• Strong verbal and written communication skills.
• Ability to supervise, train and mentor employees.
• Familiarity with ISO17025 red and current industry calibrations standards such as ASTM preferred.
• Excellent mechanical skills.
• Strong understanding of Excel.
• Strong understanding of Word.
• Strong positive team player.
• Ability to train and mentor others.
• Ability to listen and respond well to external customers, partners, and colleagues at all levels.
• Highly goal and result oriented.
• Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
• Can work independently with a high degree of self-motivation.
• Knows how to obtain support from different collaborations.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.
• Very effective listening skills with the ability to hear attentively and process information correctly.

Travel Expectations

• Up to 10% travel expected.

Physical Demands and Work Environment

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. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.