Senior Specialist -Engineering

About the role

The Modality Agnostic Chemistry Scaleup (MACS) Operations team within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. This Senior Specialist position will report to a MACS Facility Lead (Associate Director, Engineering) as a part of the core engineering team supporting the MACS facility.

Responsibilities

• Leverage depth and breadth of scientific, technical, and operational experience to support facility start up and long-term operations.
• Author and review documentation required for facility start up, non-GMP and GMP operations.
• Cleaning and Containment Verification (CCV) for the suite of specialized equipment for MACS potent processing - includes managing the CCV strategy, providing shop floor support for testing, and working with key partners in Analytical, Quality, and Safety for testing.
• Industrial Hygiene strategy and controls - includes working with Safety & Environmental partners.
• Provide mentorship and oversight for the extended team to progress facility needs.

Requirements

• Minimum Requirement: Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 5 years relevant experience, or a Master's degree with 4 years of relevant experience, or a PhD degree with 1 years of relevant experience.
• Required Experience and Skills:
  • Experience in GMP clinical supply facility.
  • Experience with GMP facility design, equipment start-up and/or qualification.
  • Experience with small molecule drug substance and/or biologics process development.
  • Experience in supporting compliance investigations and change management.
  • Familiarity with US and EU GMP and Safety compliance regulations.
  • Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
  • Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.
  • Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
  • Effective interpersonal and communication skills, both verbal and written.
  • Excellent organizational skills to multi-task.
  • Desire and willingness to learn, contribute and lead.
  • Track-record of independent problem-solving.

Qualifications

• Education: Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 5 years relevant experience, or a Master's degree with 4 years of relevant experience, or a PhD degree with 1 years of relevant experience.

Skills

• Adaptability.
• Analytical Testing.
• Antibody Drug Conjugates (ADC).
• Capital Projects.
• Change Management.
• Chemical Engineering.
• Data Analysis.
• Detail-Oriented.
• Deviation Management.
• Equipment Qualification.
• GMP Compliance.
• Good Manufacturing Practices (GMP).
• Hazard Analysis.
• Industrial Hygiene.
• Pharmaceutical Sciences.
• Process Design.
• Process Hazard Analysis (PHA).
• Process Optimization.
• Production Process Development.
• Research and Development.
• Root Cause Analysis (RCA).
• Strategic Thinking.
• Technical Leadership.
• Technical Problem-Solving.

Benefits

The salary range for this role is $117,000.00 - $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.