Senior Manager, Analytical Development
Listed on 2025-12-09
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Management
Healthcare Management, Data Science Manager
Senior Manager, Analytical Development
Bio Space seeks a Senior Manager, Analytical Development to support the development of analytical methods at ADMA Biologics
, located in Boca Raton, FL.
The Senior Manager will lead and manage a team of analytical development scientists, overseeing day‑to‑day operations, project planning, budgeting, and timelines. You will serve as a process and scientific subject matter expert, ensuring compliance with cGMP processes, training, procedures, and audit responses. You will direct validation, development, and qualification studies and reports.
Essential Functions- Direct and manage the work of analytical development scientists.
- Oversee day‑to‑day operations of the analytical development team.
- Plan for future projects, including budget and timelines.
- Ensure project timelines are met.
- Serve as a process and scientific subject matter expert.
- Ensure compliance with cGMP process, training, and procedures.
- Respond to reports from internal/external audits.
- Direct validation, development, and qualification studies and reports.
Demonstrate effective staff management, handle multiple priorities and tight deadlines, interpret regulations, and provide feedback to operations management on SOP compliance. Prepare and deliver spreadsheets, data analysis, presentations, and facilitate meetings for small and large groups. Design experiments and processes with critical thinking to analyze data and make recommendations to senior management for process improvements and development.
Qualifications Education Requirements- Master’s degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
- Bachelor’s degree and 12 years of process development experience.
- 10+ years of experience developing protein purification processes.
- Minimum of 2 years of experience in a GMP environment.
- Protein biochemistry, especially immunoglobulin chemistry.
- Assay development and validation.
- GMP method development and validation.
- Technical transfer of methods.
Compliance with FDA regulations and company policies related to sales and marketing, completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations.
Benefits- 401(k) plan with employer match and immediate vesting
- Medical, vision, life and dental insurance
- Pet insurance
- Company paid STD and LTD
- Company paid holidays
- 3 weeks’ paid time off (within the first year)
- Tuition assistance (after the first year)
- Access to Tri‑Rail
- Free shuttle to the Boca Tri‑Rail station
ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
Position Details- Seniority level:
Director - Employment type:
Full‑time - Job function:
Research, Analyst, and Information Technology - Industry: Internet News
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