PRINCIPAL INVESTIGATOR PHARMA TECH/PROCESS DEVELOPMENT

LGM Pharma Solutions LLC

• $120K — $145K *

Pharmaceuticals & Biotech

8 - 10 years of experience

Reposted 2 days ago

Be an Early Applicant

Job Overview by Ladders

Qualifications

Bachelor's degree in chemical or mechanical engineering, or related field with 8+ years of experience
Advanced degree (M.S. or Ph.D.) in Engineering or Pharmaceutical Sciences preferred
Extensive experience in pharmaceutical process development and technology transfer within a CDMO/CRO
Proven track record managing complex tech transfer projects and scale-up activities
Strong background in pharmaceutical process engineering and manufacturing technology

Responsibilities

Lead process development for scalable manufacturing processes of drug products
Design and execute studies to identify critical process parameters
Develop and optimize unit operations for smooth lab-to-pilot transitions
Implement Quality by Design and statistical process control methodologies
Serve as technical lead for technology transfer activities across multiple sites
Oversee cGMP pilot plant operations for production
Manage facility modifications and equipment qualifications

Benefits

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RESPONSIBILITIES:

Process Development & Scale-Up:

Lead process development activities to establish robust, scalable manufacturing processes for diverse drug products
Design and execute process characterization studies to identify critical process parameters (CPPs) and proven acceptable ranges (PARs)
Develop and optimize unit operations for various dosage forms, ensuring seamless transition from laboratory to pilot scale
Implement Quality by Design (QbD) principles and statistical process control methodologies

Technology Transfer Leadership:

Serve as technical lead for end-to-end technology transfer activities between R&D, manufacturing sites, and client facilities
Develop and execute comprehensive tech transfer protocols, including process comparability and equivalence studies
Lead cross-functional tech transfer teams to ensure successful knowledge transfer and process implementation
Establish and maintain tech transfer documentation systems and best practices

Pilot Plant Operations Management:

Oversee cGMP pilot plant operations for process validation, clinical, and commercial batch production
Develop and optimize manufacturing processes to enhance efficiency, yield, and quality
Implement continuous improvement initiatives for pilot plant operations and equipment utilization
Manage process troubleshooting and deviation investigations to maintain production schedules

Capital Project & Facility Management:

Lead equipment qualification and validation activities for new process equipment installations
Manage facility modification projects to support process improvements and technology implementation
Develop and execute capital project plans for process equipment upgrades and expansions
Optimize facility layout and workflow for enhanced operational efficiency

Quality & Compliance Systems:

Ensure compliance with cGMP standards (21 CFR 210/211) and data integrity requirements (21 CFR 11)
Develop and implement process validation strategies in accordance with regulatory requirements
Lead process-related investigations and implement corrective/preventive actions
Maintain audit readiness and support regulatory inspections

Project Management & Client Relations:

Manage multiple client tech transfer projects simultaneously, ensuring adherence to timelines and budgets
Serve as primary technical contact for client process-related discussions and strategy development
Develop project plans, risk assessments, and contingency strategies for tech transfer activities
Provide technical leadership and guidance to cross-functional project teams

QUALIFICATIONS:

Education & Experience:

Bachelor's degree in chemical engineering, Mechanical Engineering, or related field with 8+ years' experience
Advanced degree (M.S. with 5+ years or Ph.D. with 3+ years) in Engineering or Pharmaceutical Sciences preferred
Extensive experience in pharmaceutical process development and technology transfer within CDMO/CRO environment
Proven track record in managing complex tech transfer projects and process scale-up activities

Technical Expertise:

Strong background in pharmaceutical process engineering and manufacturing technology
Hands-on experience with process validation and equipment qualification
Extensive knowledge of cGMP requirements and quality systems
Demonstrated expertise in tech transfer methodologies and best practices
Experience with process automation and control systems

Project Management Skills:

Professional Competencies:

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