Tolmar · 2 months ago
Sr Manager Production - Aseptic
Windsor, CO
Full-time
Onsite
Senior Level
$155K/yr - $170K/yr
7+ years expTolmar is a pharmaceutical company seeking a Senior Manager Production – Aseptic to lead and oversee aseptic manufacturing operations. This role is responsible for ensuring compliance with regulatory standards, driving operational excellence, and providing leadership to production teams.
BiotechnologyHealth CareManufacturing
Responsibilities
Lead, manage, and develop aseptic production teams to achieve departmental goals and ensure high performance
Oversee daily aseptic manufacturing operations, ensuring compliance with FDA, EMA, and other global regulatory requirements
Maintain strict adherence to cGMP, SOPs, and aseptic processing standards
Partner with Quality Assurance, Engineering, and Supply Chain to ensure smooth and compliant production processes
Monitor and improve manufacturing performance through KPIs, root cause analysis, and continuous improvement initiatives
Ensure readiness for internal and external audits; lead responses to regulatory inspections and compliance findings
Drive operational excellence by identifying and implementing process improvements, automation opportunities, and lean manufacturing practices
Collaborate with the planning and scheduling teams to manage production scheduling, capacity planning, and resource allocation to meet business needs
Provide technical support and guidance on aseptic techniques, cleanroom behavior, contamination control, and process troubleshooting
Actively conduct and attend Tier Board meetings at all levels
Actively supervise and manage the performance of supervisors in the aseptic manufacturing group
Prepare and track KPIs related to OEE, process efficiencies and changeover times
Actively track and problem solve, if necessary, batch rejections based on product cost analysis
Manage the performance of operators when situations require additional management support
Conduct interviews and make hiring decisions on supervisory employees, and provide oversight on employment decisions
Interact with peers and members of other departments in team settings in a professional manner
Ensure open and transparent communication to manufacturing employees about company priorities, policies and general company announcements
Provide guidance to supervisory employees for the delivery of information
Conduct employee performance evaluations
Communicate and set daily production priorities with supervisors and manufacturing employees
Create, revise and implement Standard Operating Procedures (SOPs) and Production Batch Records
Assist with Batch Record review, as necessary, including prioritization, reviewing corrections, and following up to ensure timely completion
Ensure timely and accurate postings of all Manufacturing Orders (MOs) for month end closing
Review and take action related to monthly overhead variance report to ensure accuracy of inventory
Coordinate the completion of investigations and CAPA implementations for non-conforming events
Pre-approve expiration dates on batch records prior to manufacturing
Perform functional area management review and approval of deviations and associated CAPA actions
Complete and approve change assessments for Change Controls impacting aseptic operations area
Review and approve Inventory and Purchase Requisitions in accordance with company procedures
Identify missing items for pending manufacturing processes
Attend manufacturing department meetings
Foster a culture of safety, compliance, accountability, and continuous improvement
Demonstrate a high degree of honesty, initiative, integrity, drive, reliability and trustworthiness
Actively model and foster a positive, respectful, and harassment-free work environment for all employees
Perform other related duties as assigned
Qualification
Required
Bachelor's degree in scientific discipline or related field or equivalent experience strongly preferred
Seven or more years of experience in pharmaceutical manufacturing, with at least 5 years in production leadership roles
Experience in Aseptic / Sterile production strongly preferred
Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities
Deep knowledge of aseptic processing, sterile filling, cleanroom operations, and contamination control strategies
Proficient in Microsoft Office (Excel, Word, Outlook)
Excellent verbal and written communication skills
Ability to adhere to written production records and validation protocols
Strong understanding of basic math and writing skills to document production activities in batch records and/or log books
Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements
Strong analytical and problem solving skills
Strong technical writing and review skills
Process improvement and Lean transformation experience
Ability to support management's decisions and communicate change positively
Ability to analyze and make decisions within time and schedule constraints
Ability to quickly make decisions and understand the impact on processes and employees
Ability to lead by example and have a proven record of excellence in attendance, dependability and safety
Benefits
Bonus eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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