PRINCIPAL INVESTIGATOR PHARMA TECH/PROCESS DEVELOPMENT

LGM Pharma; Colorado Springs (CO); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Job summary

LGM Pharma is seeking an experienced Process Development & Tech Transfer Leader to drive robust, scalable manufacturing processes for diverse drug products.

You will spearhead CPP/PAR studies, design scalable unit operations, and lead cross-functional tech transfer teams from R&D to client facilities, ensuring quality and compliance throughout the product lifecycle.

Qualifications

• Bachelor's degree in chemical or mechanical engineering or related field.
• M.S. in Engineering or Pharmaceutical Sciences preferred.
• Ph.D. with 3+ years in Engineering or Pharmaceutical Sciences preferred.
• Extensive pharma process development and tech transfer experience in CDMO/CRO environments.

Responsibilities

• Lead process development to establish robust, scalable manufacturing processes.
• Design and execute CPPs and PARs through process characterization.
• Develop and optimize unit operations for dosage forms from lab to pilot scale.
• Lead end-to-end tech transfer between R&D, manufacturing, and client facilities.
• Oversee cGMP pilot plant operations for process validation and clinical/commercial batches.
• Drive capital projects for equipment upgrades and facility changes.
• Ensure compliance with 21 CFR 210/211 and 21 CFR 11.

Skills

Technical leadership

Cross-functional teamwork

Project management

Process development

Technology transfer

cGMP experience

Quality systems

Education

Bachelor's degree in chemical/mechanical engineering or related field

M.S. in Engineering or Pharmaceutical Sciences preferred

Ph.D. with 3+ years preferred

Tools

Process validation

Equipment qualification

Automation and control systems

Job description

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:

• Proven experience managing capital projects and process improvement initiatives
• Excellent organizational and time management skills
• Ability to manage multiple complex projects simultaneously
• Strong risk assessment and contingency planning capabilities

Professional Competencies:

• Excellent technical leadership and team management skills
• Strong client relationship management and communication abilities
• Ability to work effectively in cross-functional team environments
• Demonstrated problem-solving and decision-making capabilities
• Strong documentation and technical writing skills

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.