Process Development Senior Scientist - Sterile Drug Product
About the job
- A bachelor's degree with five years of experience, a master's degree with three years of experience, or a PhD or PharmD in Engineering, Pharmaceutical Sciences, Biotechnology, Biology, or Microbiology.
- Experience developing processes and establishing parameters for sterile drug product, not solely validation.
- Knowledge of aseptic processing, contamination control, and Good Manufacturing Practice.
- Experience with JMP or Minitab and LIMS.
- Bilingual proficiency in English and Spanish.
- Design and run process characterization and optimization studies for aseptic filling.
- Set and justify process parameters, and troubleshoot commercial process issues.
- Analyze data in JMP or Minitab and recommend improvements.
- Author protocols, technical reports, investigations, and change controls; support process performance qualification and technology transfer.
About the company
BioPharma Consulting JAD Group advises pharmaceutical and biotechnology businesses on engineering, quality and regulatory compliance. It works with companies operating under US Food and Drug Administration rules to develop technical solutions for their manufacturing plants and processes. Its engineering practice covers facility and equipment design, process improvements and project management, while validation work verifies and documents that production systems meet requirements. The firm sells tailored consulting and technical support for assignments and projects, with company managers involved in delivery. Founded in 2010, it is headquartered in Cambridge, Massachusetts.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Cambridge, MA
Founded
2010
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Simplify's Take
What believers are saying
- JAD Group lists major drugmakers as customers: its roster includes AbbVie, Amgen and Pfizer.
- JAD Group's Boston scientist contract advertises hybrid work and standard business hours, totaling 40 hours weekly.
- JAD Group serves remediation needs: its compliance practice covers recalls, warning letters and consent decrees.
What critics are saying
- The Boston Analytical Science and Technology Scientist contract at JAD Group spans approximately six months, with only possible extension.
- JAD Group's Norton Quality Control Analyst II requires weekends: Friday-Monday, four ten-hour shifts, after initial Monday-Friday training.
- JAD Group's Juncos drug-substance quality-assurance contract specifies 12-hour shifts and approximately 48 hours weekly on site.
What makes BioPharma Consulting JAD Group unique
- JAD Group offers paperless validation using Kneat software.
- JAD Group bridges laboratory equipment and software: its laboratory practice validates both instruments and their computerized systems.
- JAD Group covers equipment retirement: its commissioning practice includes decommissioning alongside qualification.
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