Kelly · 6 hours ago
Director of Technical Operations
Kelly Science & Clinical is seeking a Director of Technical Operations to lead collaboration with global partners and ensure compliant production of drug substances and products. The role involves improving process monitoring systems, managing compliance standards, and overseeing technology transfer efforts.
Responsibilities
Lead collaboration with global partners to ensure seamless, cGMP-compliant production of drug substances and products
Establish and continuously improve process monitoring systems including real-time dashboards tracking critical parameters
Partner closely with Regulatory and Quality teams to manage changes and uphold global compliance standards
Spearhead technology transfer and scale-up efforts at external partners, ensuring process reliability and quality
Author and review key technical documentation for regulatory submissions (INDs, etc.)
Approve validation protocols and specifications, supporting all stages of process validation
Provide technical expertise and oversight during site visits to manufacturing partners
Act as a senior resource in troubleshooting, deviation resolution, and fostering a culture of accountability
Qualification
Required
Advanced degree (M.S., or Ph.D.) in Biochemical or Chemical Engineering, Biochemistry, or a related science field
10+ years of biopharmaceutical experience in CMC operations or manufacturing, with a proven track record in MSAT or process development leadership
Mastery of statistical tools (JMP, Minitab), DOE methodologies, and data analysis
Deep knowledge of relevant manufacturing platforms (biologics, small molecules, pegylated therapeutics, combination devices)
Demonstrated skill in managing global manufacturing relationships and technology transfers
Experience navigating the path from late-stage development to commercial launch is a significant advantage
Exceptional leadership, team-building, and communication abilities
Proven problem-solving prowess with a focus on sustainable solutions
Comfortable working in collaborative, growth-centered environments and adept at adapting to change
Company
Kelly
We’ve been helping organizations find the people they need longer than any other company in the world.
H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (64)
2024 (78)
2023 (70)
2022 (75)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Recent News
Kelly Services, Inc.
2025-11-08
2025-11-08
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