Overview
Kelly® Science & Clinical is seeking to connect with Director-level candidates for future Technical Operations opportunities with our clients in the San Francisco Bay Area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Workplace : Onsite in the Bay Area
Pay rate : $200,000-230,000 / year
Base pay range
$200,000.00 / yr - $230,000.00 / yr
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.
Qualifications
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 changeWhat happens next?
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
Seniority level
DirectorEmployment type
Full-timeJob function
Manufacturing, Management, and ScienceIndustries : Biotechnology Research and Pharmaceutical Manufacturing#J-18808-Ljbffr