MSD-posted 1 day ago
Full-time • Director
Hybrid • Rahway, NJ
5,001-10,000 employees

Our Company's microbiology team is seeking a Director for the Rahway NJ, Good Manufacturing Practice (GMP) microbiology operations. The primary objective of the position is to oversee GMP environmental monitoring and microbiological release of pipeline products. The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include executing analytical methods to release clinical drug substance and drug product and support both non-sterile and sterile manufacturing. This role contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable, which involves the development of robust chemical and biochemical processes, market formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality, Pharmaceutical Operations, the other Research & Development Division Microbiology labs in the network and partners in commercialization and manufacturing in aspects of quality control, compliance, and strategic partnering.

  • Reports to the Executive Director of Microbiology in Analytical Research and Development (AR&D)
  • Leads an expanding team of operational scientists at the Rahway NJ site.
  • Responsible for clinical release for various processes and dosage formulations.
  • Engages with the microbiology leadership team and extended leadership teams to advance departmental strategic and cultural initiatives.
  • Identifies, recruits, onboards, and develops employees.
  • Establishes a viable succession plan for key positions.
  • Ensures current GMP compliance and operational excellence in the laboratories.
  • Maintains a state of inspection readiness.
  • Performs proactive resourcing planning and risk assessment strategies.
  • Advances a culture of scientific excellence, GMP compliance mindset, and collaboration with various partners and stakeholders in other development departments.
  • Leads microbiological investigations
  • Review and approval of data and reports.
  • SOP development.
  • Pharmaceutical Microbiologist (Direct GMP Operations Experience).
  • Strong people management skills.
  • Extensive experience with sterile operation and sterile testing laboratoriums.
  • Demonstrated ability in leading teams and talent development.
  • Project management skills.
  • Ability to work in a team environment with cross-functional interactions.
  • Excellent scientific communication, interpersonal, and collaborative skills.
  • Strength in delivering results on firm deadlines.
  • Experience representing the laboratory for internal and external audits.
  • Quality System experience.
  • Thorough working knowledge of GMPs, ICH, Pharmacopoeia, and relevant FDA guidelines.
  • Desire and ability to learn new concepts outside of core expertise and training
  • BS or MS in Microbiology/Molecular Biology or related science with at least 10 years of industrial experience leading a QC lab and working together with operations.
  • Ph.D. in Microbiology/Molecular Biology or related science with 5 years of industrial experience leading a QC lab and working together with operations.
  • Adaptability
  • Adaptability
  • Analytical Method Development
  • Biologics License Application (BLA)
  • Chromatographic Techniques
  • Decision Making
  • Dosage Forms
  • GMP Compliance
  • Immunochemistry
  • Inspection Readiness
  • Learning New Concepts
  • Microbiological Analysis
  • Microbiology
  • Molecular Biology
  • Molecular Microbiology
  • People Leadership
  • People Management
  • Process Analytical Technology (PAT)
  • Professional Networking
  • Project Management
  • Quality Control Management
  • Regulatory Compliance
  • Regulatory Submissions
  • Results-Oriented
  • Standard Operating Procedure (SOP) Development
  • medical
  • dental
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
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