Employers Pro Advantage Inc. a Native Alaskan Women owned sdb specializing in the placement of highly skilled professionals in Accounting and Finance, IT/MIS and legal services. Employers Pro Advantage Inc. has been in business since 1997 servicing New Mexico and the surrounding states with high results.
We are currently seeking a Sr. Manufacturing Manager for our client's night shift. The position is located in Albuquerque, NM. Relocation assistance is available.
- Responsibilities are for both Drug Substance (API) and Drug Product aspects of commercial pharmaceutical product manufacturing.
- Develops and maintains good working relationship with contract manufacturers.
- Manage CMO contracts.
- Develop SOPs and work processes needed for Commercial Manufacturing.
- Works with CMOs to diagnose and correct process issues.
- Identifies and evaluates CMOs for the manufacture of Commercial products.
- Develops, collects appropriate metrics to measure CMO performance.
- Works with Quality Group to determine the impact of process deviations and works towards resolutions.
- Develops timelines, goals, and deliverables for API, Drug product and related manufacturing processes.
- Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs..
- With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
- Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
- Initiates and coordinates the preparation of CMC documentation as required.
- Collaborates with Regulatory Affairs and other groups to support product filings.
- Assists in contract site preparation activities for regulatory inspections.
- Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues.
- Provide onsite process coverage as person-in-plant as needed.
- Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.
- Supervise, train and mentor personnel as needed.
BS in Engineering/Chemistry/Biology, Masters preferred. A minimum of 10 years of progressively responsible experience within the pharmaceutical/biotechnology industry with 5 years in a leadership role.
- Strong understanding is required of the biopharmaceutical drug development process including regulatory filings and quality inspections and audits.
- Extensive knowledge of regulations as they pertain to post-approval manufacturing process changes; site changes, etc.
- Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
- Extensive knowledge of current Good Manufacturing Practices (cGMPs) and demonstrated experience in manufacturing process development for new drugs.
- Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.
- Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
- Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.