LIMS Project Manager
Proclinical is currently recruiting for a Laboratory Testing LIMS Project Manager with a pharmaceutical company located in Philadelphia, PA.
- Responsible for the strategic and tactical planning of samples for core testing programs including Molecular Biology, Virology, QC Cell Biology, Analytical Chemistry, Cell Biology, and Virus Production, and Viral clearance including routing GMP testing, method qualifications, and test article validations.
- Responsible for managing overall sample throughput on the master schedule within all assigned departments and for managing projects to expand scheduling capabilities within the organization.
- Serve as a lead scheduler for assigned departments within testing operations to manage sample workload for Testing Operations including Routine GMP testing, as well as protocol Qualifications, and Test Article Validations for client products.
- Liaison for manufacturing and testing plants to support sample transfers between plants and ensure successful hand off and on-time-delivery for lot release testing.
- Coordinate short to long-term plant production loads to maintain tactical sample throughput that meets testing capacity through the creation of a master production schedules and/or supply plans.
- Perform projects to establish capacity models across testing departments utilizing established time study data and collect time study data as needed for new assays within Testing Operations.
- Support the creations of database for processes, test methods, unit operations, cycle times, down times, and various key performance indicators for advanced planning software, schedule optimization, and monitoring performance.
- Attend regular L3 Operations meetings to keep management and senior leadership teams apprised of critical product supply & demand issues including backlogs, prioritization issues, and other escalations to facilitate schedule adherence, conflict resolution, and client satisfaction.
- Establish formal testing priorities with Sales, Marketing, and Operation leaders based on business plans, project revenue projections, forecasted sample volumes, and critical due dates for regulatory filings or patent treatment.
- Review and resolve inconsistencies and conflicts in the master schedule.
- Identify and develop best practices and processes for resolving schedule conflicts.
- Maintain accurate master data in SAP, LIMS, and other scheduling systems as needed; assist plant(s) in maintaining local master data.
- Attend leadership meetings and give presentations on Key Performance Indicators (KPIs) for Schedule Adherence, On-Time-Delivery, and Right First Time across departments within Testing Operations utilizing LIMS metrics reports.
- Support site wide tier system schedule communication and attend manufacturing and testing huddles as needed.
- Support continuous improvement projects for Testing Operations based on time and effort required.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Skills and Requirements:
- BS or MS in Engineering, Industrial Engineering, Supply Chain, Operations, or other related disciplines
- 2-4 years of relevant experience or equivalent with GMP biologics testing
- 2+ years of scheduling, supply planning, or operations management experience
- Knowledge of corporate systems including MRP/ERP systems LIMS, Etc.
- Ability to effectively build relationships and influence others to achieve goals and project objectives
- Excellent verbal and written communication skills
- Proven analytical and organizational skills
- Proficiency in Microsoft Power Point, Word, and Excel, Project
- Problem solving, project management, or planning experience
- Knowledge of MRP/ERP systems, including SAP, LIMS, Etc.
- Some knowledge of Lean, 6 Sigma, and continuous improvement
- Ability to effectively build relationships and influence others to achieve goals and project objective
- Have excellent inter-personal skills and communication skills
- Have strong analytical and problem solving skills
- Strong collaborative skills with an ability to work effectively in a team environment
- Have creativity to identify improvement opportunities and the initiative to see them implemented.
- Proficient in Microsoft Office Suite (Excel, Word, Powerpoint, Outlook and Access)
- Experience with Excel VBA programming is a plus
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.