Lab Operations Manager W2 ONLY 7525676
South San Francisco, CA
7525676 Lab Operations Manager
W2 Only 12 Month Contract
Location: South San Francisco, CA
Top Skills: 5 to 8 yrs exp Project management, PTDU-D laboratory, GMP, GDP, GLP, sample management, project planning, scheduling, MS Office Suite, ISO 1345, FDA, EU, Drug Development
The Lab Operations Manager will be responsible for ensuring the device development laboratories run safely and efficiently and meet our client' s Quality requirements, and for leading and directing the development, communication and implementation of processes for said laboratories to support project teams developing combination drug delivery devices for pharmaceutical therapeutics.
The candidate will work with general direction, and independently prioritizes work and minimizes or mitigates risks. The work is reviewed upon completion.
Quality Systems Compliance:
- Understand, implement and maintain our client' s Pharma Quality Policy and Pharma Quality System (PQS) in the PTDU-D laboratory.
- Ensure PTDU-D laboratory is organized and operating according to relevant GMP requirements.
- Ensure test records and instrument/equipment logs are completed and maintained as required.
- Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
- Ensure laboratory user training compliance with PQS and job-related requirements.
- Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
- Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents
- Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:
- Schedule testing, including stability studies, per test requests.
- Manage laboratory sample inventory, sample transfer in/out of storage, and document per Quality System requirements. Schedule and execute disposal of expired or obsolete or expired samples.
- Communicate with medical device development engineering team leads to forecast storage and testing requirements.
- Ensure lab staff and other lab users are trained as required.
- Define, oversee and track Laboratory progress in meeting milestones and deliverables.
- Partner closely with Laboratory Manager and Device Development Leadership to define and execute the laboratory operations strategy and facilitate team meetings with key stakeholders to drive sharing of information, efficient decision-making, issues resolution, risk mitigation and team member engagement.
- Ensure optimal utilization of resources (human, instrument, space, etc.) to meet laboratory goals
- Connect with management to provide regular project updates on project status including performance
- metrics, risk mitigation plans, and to escalate unexpected events impacting project schedule, budget and resources.
- Support business process improvement efforts (e.g. updating business process content, implementing tools and best practices, and driving awareness across Teams.)
- Experience in combination products is highly desirable.
- Expertise in the drug development process is expected; need to have demonstrated practical experience and knowledge of medical device development and commercialization. Ability to integrate science, drug and device development knowledge and regulatory expectations to execute project plans.
- Experience in leading and managing a team to meet broad and specific team objectives.
- Experience managing operations in GMP or other regulated lab including test scheduling, resource scheduling, equipment qualification and maintenance, method validation, operations, and safety
- Application of relevant skills, tools and requirements
- For example: Sample management and resource scheduling skills.
- Proficient computer skills as well as knowledge of inventory management systems and database programs.
- Project planning, scheduling, tracking team deliverables and actions, facilitating team decisions, risk management, resource and cost forecasting, meeting management, regular project status communication, PMP certification
- Software tools: Google, Microsoft Office, WebEx, Visio, Project
- Requirements: International standards (e.g. ISO 13485), federal regulatory compliances (e.g. FDA and EU), filings, relevant health authority regulations, Drug Development processes, Design Controls, GDP/GLP/GMP, Design History Files
- Ability to translate high-level operational requirements of the lab into actionable action plans
- Demonstrated ability to communicate laboratory requirements, status, and challenges to stakeholders and management
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment.
- Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building, etc) are required.
- Highly organized and detail oriented.
- Must be able to effectively communicate and align plans in a highly matrix organization and with external party as applicable.
- Be accountable for behaviors described in our client' s Core, Common and Critical Competencies.
- Enroll in required training based on business/project need.
- Flexible in problem solving, providing direction and work hours to meet business objectives.
- Manage and lead a small team of Eurofins Lancaster Laboratory employees in meeting team goals and coordinate with affiliates to accomplish broader goals.
Education and Industry Experience:
- Minimum 5-8 years laboratory experience, with at least 3 years in a leadership role.
- A working knowledge of GMP and GLP best practices is a plus.