Commitment: Full Time, Contract
Full Job Description
- Serve as MSAT representative on client project teams.
- Actively support process optimization and implementation of strategies for improving Upstream/Downstream unit operations throughout the product lifecycle.
- Provide resolution of deviations, investigations, and process issues.
- Network with Process Development, Manufacturing, and Quality team members to ensure reliable state to process control, and drive continuous improvements.
- Participate in review and analysis of manufacturing campaign data trending, and present daily progress, as well as end of campaign summary updates.
- Support emergent events response for on-floor manufacturing issues.
- Generate and maintain documents related to GMP Manufacturing executions, product impact assessments, and campaign summary reports.
- Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biologic Bulk Drug Substance(s).
- Provide technical leadership to Manufacturing and other departments associated with GMP operations.
- Serve as the process Subject Matter Expert; provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
- Participate in the project team meetings, decisions, and creation of milestones representing MSAT.
- Prepare and present data associated with manufacturing processes to internal and external clients.
- Maintenance of Process Control Strategy
- Process training, as needed, in adherence to company policies and quality requirements.
Knowledge, Skills & Abilities
- · Must be self-motivated, organized and proactive.
- · Demonstrated ability to interface/communicate extensively with internal and external clients.
- · Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, QC, etc.).
- · Proven experience successfully managing multiple projects simultaneously.
- · Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products.
- · Demonstrated experience leading troubleshooting efforts.
- · Ability to provide technical training to others on GMP manufacturing operations.
- · Strong communication skills necessary to interact with internal stakeholders.
- · Strong presentation skills.
- · Expertise in relevant math, science and engineering disciplines.
- · Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function.
- · BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred.
- · 3+ years’ relevant experience from the pharmaceutical industry working in a cGMP environment.
- · Advantage with relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness.
- · Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
- · Must have experience writing, reviewing and approving GMP documentation.
- · Advanced computer skills including Excel and Word.
Job Types: Full-time, Contract