Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world.
The Sr Manufacturing Manager that supports our Agena Bioscience business has responsibility foroverseeing GMP production of products internally manufactured to include mass spectrometer equipment as well as related consumables such as SpectroCHIPs and molecular diagnostic formulations associated with reagents implemented and integrated into complex diagnostic assay systems.
Key Job Responsibilities:
- Supervises and trains Manufacturing Technicians in areas of equipment manufacturing, consumables manufacturing, and kitting.
- Develops and ensures adherence to the manufacturing schedule
- Formulates complex GMP mixes and provides in-process testing capacity
- Reviews and approves technical instructions and procedures to formulate, fill, and package molecular biology consumable assay components
- Supports the implementation of design control, QSR and GMP production in an FDA regulated environment
- Subject Matter Expert in areas of compliance to production, process controls SOPs and regulations.
- Represents manufacturing on tours and various customer, internal, and external audits.
- Ensures timely material availability and shop floor scheduling
- Supports the transfer of new processes into a manufacturing setting
- Supports continuous improvement, corrective and preventative action projects
- Closely interacts with R&D, Engineering, Materials, and QA/QC departments in product introduction, change controls, deviations and technical troubleshooting projects
- Monitors manufacturing compliance to procedures and standard cost evaluations/variances
- Ensures compliance with all documentation and production record keeping
- Maintains TQM and metric development and accountability
- Manages staff on multiple manufacturing lines in areas of recruiting, hiring, motivating, performance management, succession planning, training, cross-training, and development.
- Other duties as required
Qualifications/Education:
- Bachelor’s degree in a scientific or engineering discipline.
- Minimum 5 years people leadership experience required.
- Experience in GMP manufacturing.
- Working knowledge of regulated design controls e.g. ISO 13485, cGMP is preferred.
- Experience in lean manufacturing and/or Six Sigma is preferred
- Previous experience with mass spectrometry (such as MALDI-TOF), a plus
Compensation/Benefits:
The company offers a comprehensive benefits package and compensation for this position. The package includes base salary, bonus, equity,medical/dental/vision insurance, 401k/Match.
Base Salary Range for this position is $108,000-$143,000.
Mesa Labs is an Equal Employment Opportunity Employer.
Mesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)