Biologics Process Development Senior Manager

Job Locations US-MD-Silver Spring
# of Openings
1
Category
WRAIR PBF
Type
Regular Full-Time

Overview

CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.  This position will support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

  • Demonstrates cGMP manufacturing compliance and quality without continuous supervision.
  • Oversees and leads technology transfer of biologics processes, performs risk assessments and represents PBF at meetings.
  • Leverages broad experience to operate and train staff; and if needed performs non-routine maintenance on laboratory equipment.
  • Leverages advanced academic background and industry experience to design, lead and implement process characterization and biologics scale-up.
  • Creates, revises and executes cGMP documentation including procedures, specifications, and automation recipes as required.
  • Assists cGMP operations as required; assists and stands-in for VDAD and operations managers as required.
  • Assists in development, optimization and implementation of bench and production scale upstream, downstream and fill-finish process development.
  • Leverages experience, bioprocessing expertise and leadership to advance WRAIR PBFs projects.
  • Manages department budget, attends staff meetings and reports performance metrics as required.
  • Compiles and reviews executed development data, engineering run data, process data and Master Batch Records.
  • Recommends and specifies equipment and other supply purchases within the development areas.
  • Assists business development efforts including customer presentations, project cost and schedules and proposal development as required.
  • Compiles data supporting risked-based process decisions, presents data and resolves mitigation through research and experimentation as required.
  • Leads and supports initiation and closure of investigations, deviations and CAPAs
  • Reviews cGMP records and data as required, supports regulatory CMC sections as required and represents PBF at technical conferences.
  • Responds and/or monitors equipment as required to equipment notifications.
  • Other duties as assigned.

Qualifications

  • Bachelors degree in engineering or sciences degree with additional industry experience. Masters in Engineering or PhD in related science preferred.
  • 15+ years Good Manufacturing Procedures (cGMP) manufacturing.
  • Familiarity with related fields such as microbial physiology, general microbiology, microbial fermentation, mammalian cell culture, physical chemistry, and biochemistry preferred.
  • High throughput process parameter screening, DOE and data analysis preferred.
  • Independently lead manufacturing teams as required potentially working off-hour shifts as required and resolving process alarms.
  • Experienced in operation of bioreactors, centrifuges, ultrafiltration, and cell disruption equipment.
  • Proficient at Microsoft office, especially MS Excel and Word.
  • Support initiation and closure of deviations and CAPAs, lead investigations and be responsible for closing deviations.
  • Compilation of upstream electronic and offline data.
  • Comfortable and effective presentation of process data to internal and external peers, customers and stakeholders.
  • Business acumen including experience with accounting, finance and marketing is a plus.

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