BioPharma Consulting JAD Group
Manufacturing Technical Operations
Full-Time
No salary listed
Expert
Bachelor's
Boston, MA, USA
In Person
About the job
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Project Management, or a related field.
- 10+ years of experience in a pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
- Proven ability to independently lead high-complexity investigations and corrective and preventive actions in a fast-paced environment.
- Deep understanding of current Good Manufacturing Practices, Food and Drug Administration and European Medicines Agency regulations, and quality systems.
- Extensive experience with electronic Quality Management Systems.
- Exceptional analytical, problem-solving, and technical writing skills.
- Strong leadership presence with the ability to influence and guide cross-functional teams.
- Demonstrated ability to manage multiple high-visibility records simultaneously while meeting aggressive timelines.
Responsibilities
- Lead high-complexity deviation investigations, including triage, data mining, GEMBA walks, and coordination with multidisciplinary subject-matter experts.
- Drive advanced root cause analysis using 5-Why, Ishikawa, Kepner-Tregoe, and GEMBA methodologies to identify systemic issues and prevent recurrence.
- Own and execute complex corrective and preventive actions, ensuring robust effectiveness checks, cross-functional alignment, and sustainable long-term solutions.
- Initiate and guide Change Control records, ensuring accurate impact assessments, risk evaluations, and implementation strategies.
- Lead analytical and Quality Control investigations, including method performance review, data trending, and identification of quality risks.
- Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
- Serve as a senior technical authority during internal audits, external inspections, and regulatory interactions.
- Partner with Manufacturing, Quality Control, Quality Assurance, Manufacturing Sciences and Technology, Engineering, and Supply Chain to resolve complex issues and strengthen process robustness.
- Identify patterns and recurring deviations, leading cross-functional initiatives to reduce variability and improve manufacturing reliability.
- Mentor junior and mid-level investigators, providing coaching on investigation strategy, documentation quality, and compliance expectations.
Desired Qualifications
- Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing.
- Proficiency with Manufacturing Execution Systems, Laboratory Information Management Systems, TrackWise, or similar systems.
- Formal training in advanced root cause analysis methodologies, including Kepner-Tregoe, Ishikawa, and 5-Why.
- Experience mentoring and developing investigation talent.