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.
