Director of Analytical Chemistry
Job TitleDirector of Analytical Chemistry
Employment TypeDirect Placement
Director of Analytical Chemistry
Expand your professional portfolio as the Director of Analytical Chemistry SCA Pharma in Windsor, CT. As the Director of Analytical Chemistry, you will guide analytical chemists and method development chemists to ensure all testing is done as efficiently and effectively as possible. This is a direct-hire opportunity.
- Competitive pay
- Health benefits
- Relocation assistance
- Direct-hire opportunity
- Advanced degree in Chemistry, Analytical Chemistry or related field with 15+ years relevant experience
- 10+ years of management experience
- Experience with sterile pharmaceutical, medical device, or biotech manufacturing (preferred)
- Knowledge of cGMP, ICH, FDA, DEA regulations or guidelines
- Ability to work cross-functionally to achieve business outcome
- Extensive knowledge of Analytical Chemistry theory and the operation and troubleshooting analytical laboratory equipment
- Expert-level understanding of technologies and practices for regulated quality labs (preferred)
- Strong troubleshooting skill for analytical chemistry methods
- Experience in handling control substances in cGMP environment
- Strong scientific technical writing including authority SOPs or technical/investigational reports
- Develop, validate and verify analytical methods for raw materials, in-process control, intermediate drug product and finished drug product testing
- Identify and address technical and validation gaps in analytical methods and ensure continuous improvement to ensure efficient testing models
- Participate in regulatory inspections as SME and develop responses to observations
- Maintain, monitor and optimize the stability program for finished products
- Analyze stability studies to determine appropriate shelf life and specifications for drug product
- Manage and improve Chemistry Lab logistics activities including sample management, test/release schedule, cycle time matrix, capacity management and LIMS, etc.
- Manage outside contract laboratory relationships, including method validations, investigations, audits, cost and invoices to meet project timelines and business requirements
- Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
- Purchase, calibrate and qualify Chemistry laboratory equipment systems and software (e.g., Empower, LIMS, etc.) to meet the compliance (data integrity) requirements and project timeline
- Oversee the DEA compliance and improve controlled substance handling efficiency (e.g., samples, waste and inventory process, etc.)
- Identify continuous improvement projects to increase lab operation efficiency, reduce paper work and cycle times including the readiness for Rapid Micro applications
- Oversee LIMS development, implementation, operation, troubleshooting and maintenance
- Oversee laboratory safety program to provide the analysts a safe working environment and ensure laboratory meet the safety requirements
- Represent Chemistry lab to communicate in daily site huddle meetings daily shift meetings, weekly production meetings, biweekly DAR/MOC/CAPA/OOS/LEI/Deviation meetings
- Develop, implement and present metrics for monitoring of lab operations, stability program and analytical characteristics of the finished products
- Hire and develop team members, idenitfying those with leadership potential, conduct performance review and disciplinary actions
Headquartered in Augusta, Georgia and founded in 1973, MAU Workforce Solutions is a multi-faceted business solutions provider offering professional recruiting, commercial staffing, outsourcing, and human resources services. World class companies across the globe utilize our customized workforce solutions in order to gain a competitive advantage.
MAU is a family-oriented organization that has built its foundation upon strong values of dedicated service, loyal relationships and tailored business solutions all of which still remain today.
Disclaimer: All applicants must submit to background check and drug screening.
This position does not offer sponsorship
Equal Opportunity Employer
Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply