PRINCIPAL INVESTIGATOR PHARMA TECH/PROCESS DEVELOPMENT

RESPONSIBILITIES:Process Development & Scale-Up:Lead process development activities to establish robust, scalable manufacturing processes for diverse drug productsDesign 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 scaleImplement Quality by Design (QbD) principles and statistical process control methodologiesTechnology Transfer Leadership:Serve as technical lead for end-to-end technology transfer activities between R&D, manufacturing sites, and client facilitiesDevelop and execute comprehensive tech transfer protocols, including process comparability and equivalence studiesLead cross-functional tech transfer teams to ensure successful knowledge transfer and process implementationEstablish and maintain tech transfer documentation systems and best practicesPilot Plant Operations Management:Oversee cGMP pilot plant operations for process validation, clinical, and commercial batch productionDevelop and optimize manufacturing processes to enhance efficiency, yield, and qualityImplement continuous improvement initiatives for pilot plant operations and equipment utilizationManage process troubleshooting and deviation investigations to maintain production schedulesCapital Project & Facility Management:Lead equipment qualification and validation activities for new process equipment installationsManage facility modification projects to support process improvements and technology implementationDevelop and execute capital project plans for process equipment upgrades and expansionsOptimize facility layout and workflow for enhanced operational efficiencyQuality & 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 requirementsLead process-related investigations and implement corrective/preventive actionsMaintain audit readiness and support regulatory inspectionsProject Management & Client Relations:Manage multiple client tech transfer projects simultaneously, ensuring adherence to timelines and budgetsServe as primary technical contact for client process-related discussions and strategy developmentDevelop project plans, risk assessments, and contingency strategies for tech transfer activitiesProvide technical leadership and guidance to cross-functional project teamsQUALIFICATIONS:Education & Experience:Bachelor's degree in chemical engineering, Mechanical Engineering, or related field with 8+ years' experienceAdvanced degree (M.S. with 5+ years or Ph.D. with 3+ years) in Engineering or Pharmaceutical Sciences preferredExtensive experience in pharmaceutical process development and technology transfer within CDMO/CRO environmentProven track record in managing complex tech transfer projects and process scale-up activitiesTechnical Expertise:Strong background in pharmaceutical process engineering and manufacturing technologyHands-on experience with process validation and equipment qualificationExtensive knowledge of cGMP requirements and quality systemsDemonstrated expertise in tech transfer methodologies and best practicesExperience with process automation and control systemsProject Management Skills:Proven experience managing capital projects and process improvement initiativesExcellent organizational and time management skillsAbility to manage multiple complex projects simultaneouslyStrong risk assessment and contingency planning capabilitiesProfessional Competencies:Excellent technical leadership and team management skillsStrong client relationship management and communication abilitiesAbility to work effectively in cross-functional team environmentsDemonstrated problem-solving and decision-making capabilitiesStrong documentation and technical writing skillsAt 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.

Apply Now