Supervisor Metrology

Bora Pharmaceuticals; Maple Grove (MN); On-site; USD 88,000 - 115,000; Full time

Benefits offered by this job

Salary & incentives

Health insurance

Retirement plan

Paid time off

Professional development

Wellness programs

Employee assistance

Job summary

Bora Pharmaceuticals, a premier CDMO, seeks a Metrology Supervisor to lead the Calibration and Instrumentation group. You will ensure calibration, qualification, maintenance, and compliance of laboratory and manufacturing equipment.

You will provide strategic direction and mentorship to the team to uphold cGMP standards. The role involves coordinating with Quality and senior management, managing calibration data reviews, and driving process improvements.

Qualifications

• Bachelor's degree with minimum 5 years' pharma industry experience OR Master's degree with minimum 3 years' experience in pharma.
• Analytical chemistry knowledge.
• Experience working in a laboratory environment, preferably pharma.
• Leadership experience preferred.
• Experience with metrology preferred.

Responsibilities

• Provides leadership to the Metrology team, including staff development and coaching.
• Demonstrates mentoring and professional development for direct reports.
• Maintains strong communication within Bora and across the organization.
• Maintains effective written and verbal communication in meetings and via documentation.
• Serves as subject matter expert for instrumentation and cGMP compliance.
• Plans instrument/equipment, maintenance and calibration activities to support end users.
• Develops, implements and monitors SOPs and calibration procedures; ensures cGMP compliance.
• Communicates calibration results and deviations to Quality and senior management.
• Coordinates with outside vendors and 3rd party labs for calibration results.
• Evaluates Metrology systems and processes; drives efficiency and cost savings.
• Participates in FDA, customer and internal audits and responds to deficiencies.
• Reviews departmental budget and approves expenditures as necessary.

Skills

Analytical chemistry knowledge

Leadership

Metrology experience

Education

Bachelor's degree in chemistry or engineering or related science with 12 credits chemistry

Master's degree in chemistry or engineering

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary

Supervises Metrology group, which is comprised of personnel responsible for laboratory instrument qualification, maintenance and calibration, as well as manufacturing/packaging equipment calibration. Ensures laboratory instrumentation is appropriately identified, qualified, calibrated and maintained and manufacturing and packaging equipment is properly calibrated. Provides technical support for purchasing and maintaining instrumentation/equipment. Ensures final review of calibration/maintenance documents is appropriate. Provides leadership and technical expertise in response to problems (e.g. instrument investigations and CAPAs). Ensures the calibration program is operated under cGMP's and that the Metrology team operates in compliance with safety program. Provides input on the department budget. Ensures the team operates in a safe manner, and all personnel are properly trained on compliance and safety.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Essential Job Functions

• Provides leadership to the Metrology team. Ensures the group has the education, training and experience necessary to perform assigned functions (i.e. interviews and recommends staff, provides work direction and guidance, coaches and develops personnel).
• Demonstrates mentoring skills. Manages personnel development and behavior to ensure a professional environment. Reviews personal development areas with direct reports.
• Demonstrates cooperation and professionalism with all members of the Bora organization. Maintain strong communication skills within the company by addressing issues properly. Display strong critical thinking skills.
• Demonstrates strong written and verbal communication skills. Participates in departmental, interdepartmental and industry meetings as necessary. Demonstrate networking skills throughout the company and industry.
• Functions as a subject matter expert for instrumentation and cGMP compliance as applicable. Demonstrate an understanding of applicable regulations and guidance (e.g. USP, DEA, EPA, OSHA, and FDA).
• Provides information to the team to aid in the planning of instrument/equipment, maintenance and calibration activities to support the equipment end users.
• Aids in developing, implementing, and monitoring appropriate procedures and controls (e.g. SOP's, Work Instructions, and instrument/equipment calibration requirements). Evaluate procedures to ensure cGMP compliance.
• Highlights misuse of instrumentation/equipment to the appropriate department management.
• Conducts the final review of calibration data and instrument qualifications as necessary.
• Responsible for communicating instrument/equipment out of calibration results to Quality and senior management. Conducts deviation investigations on out of specification results for calibrations.
• Communicates with outside vendors/ calibration laboratories as appropriate. Ensures the coordination and review of the calibration results from 3rd party testing laboratories are appropriate.
• Evaluate Metrology systems and processes. Implement process changes for efficiency improvements and cost savings. Ensure efficiencies are built into the technician's day-to-day tasks. Continue to increase their productivity, while maintaining error-free work.
• Participate in the FDA, customer and internal audits. Develop and implement deficiency responses to the audits.
• Review and provide input for the departmental budget. Approve expenditures as necessary. Conducts internal and external audits as necessary.
• Review Pharm Forum and USP as necessary. Ensure procedures are updated accordingly. Respond to the USP as necessary.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience, & Skills

Bachelor's degree or master's degree in chemistry, Engineering or related science field with 12 credits of college chemistry, preferably with courses in analytical instrumentation.

• Bachelor's degree with a minimum of 5 years' experience, preferably in the pharmaceutical industry OR a master's degree a minimum of 3 years' experience, preferably in the pharmaceutical industry.
• Analytical chemistry knowledge.
• Experience working in a laboratory environment, preferably in the pharmaceutical industry.
• Leadership experience preferred.
• Experience with metrology preferred.

Compensation Range

$88,000 - $115,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.