Hossain
Project Manager | Pharmaceutical & Clinical Labs | ALS Global USA | cGMP | FDA | Open to Saudi Arabia
- Role
- Project Manager Client & Site Operations Lead at Als Group Usa, Corp
- Location
- Torrance, CA, US
- LinkedIn followers
- 500 followers
About Hossain
Senior Project Leads and Pharmaceutical Scientist with 12+ years of experience leading pharmaceutical manufacturing, clinical research support, cosmetics, and regulated laboratory operations.Currently serving as Project Manager at ALS Global (USA), managing complex pharmaceutical and personal care testing programs for FDA- and cGMP-regulated clients. Proven expertise in end-to-end project execution, site operations, regulatory inspections, audit readiness, and cross-functional leadership.Previously served as Plant Manager overseeing full pharmaceutical manufacturing operations and teams of up to 80 staff across production, quality, and compliance functions.Key strengths include:• Project & Program Leadership (Pharma, Clinical, Laboratory)• Site & Operations Management• Regulatory Compliance (FDA, cGMP, GLP, ICH)• Audit & Inspection Readiness• Budgeting, Resource Planning & Team Leadership• Client & Stakeholder ManagementActively seeking Operation Manager, Site Head, or Senior Project Leadership roles in Saudi Arabia within pharmaceutical manufacturing, clinical research organizations (CROs), healthcare laboratories, or regulated testing environments.
Experience
Project Manager Client & Site Operations Lead
Nov 2023 — Present · US
Specialize in Food and Pharmaceutical, Beauty and Personal Care Project Management, Analytical Chemistry, Analytical Instruments, Project Profile and Project Report, NCMR, OOS and Deviation.Responsibilities:Projects involved methods utilizing HPLC, ICP-OES, ICP-MS, GC, UV-Vis, Dissolution, titrations and other wet chemistry instruments • Facilitate and lead projects that pertain to commercial products transitioning to new equipment and or processes.• Communicate with customers on project status.• Prepare and manage project plans to meet milestones.• Communicates cross-functionally to facilitate seamless delivery of projects.• Collaborate with QA and clients directly on IND and NDA projects. • Responsible for protocol, data review, method, SOP and report generation.• Sometimes work with hazardous and cytotoxic materials.• Assisting in troubleshooting instruments and methods, and interfacing with vendors in equipment repair, acquisition and qualification.• Strong pharmaceutical project management skills and proven experience in having managed capital projects with emphasis on Biologics, clinical and/or manufacturing and development laboratories in a cGMP environment.• Experience in total project delivery in a cGMP environment (from concept to validation and startup process). Leads the development of the capital project scope and objectives in support of the business strategy dealing with clients and stakeholders.
Education
Southern University Bangladesh
Master's degree, Pharmacy
2010 — 2011
University of Science and Technology, Chittagong
Bachelor's degree, Pharmacy
2004 — 2009
USTC chittagong
Bachelor's degree, Pharmacy, Pharmaceutical Sciences, and Administration
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