Provides executive leadership and direction for formulation, technical manufacturing development for equipment, and manufacturing operations. The primary responsibilities include increase operating efficiency through improved formulas, machine set-up and efficiency, technical affairs associate with manufacturing pilot lab and standard operations. Directs: development, communication and implementation of policies, procedures, systems enhancements, budget, capital expenditures and projects. Successfully manages initiatives to achieve Company and departmental profit, growth, operational efficiency, sales objectives, coordinating and maintaining matrix relationship with internal & external stakeholders.
Primary Duties and Responsibilities:
1. Directs the activities as assigned for product formulations, manufacturing / equipment efficiencies, regulatory and testing compliance.
2. Setting up Formulation prototype and pilot plant at the new site.
3. Developing quality system with continuous up-gradation and maintaining in-house pilot plant under cGMP environment.
4. Ensure installation and qualification of formulation and pilot plant equipment/ instruments.
5. Lead scale up activities, technology transfers, process optimization/validation based on QA/QC, cGMP, regulatory compliance at in-house pilot plant which includes data interpretation and establishing critical process parameters along with control strategies.
6. Ensure timely manufacturing & submission of batches for pilot study with compliance and integrity.
7. Ensure to prepare & review of various technology transfer documents (Formula, optimization/validation protocol, stability protocol, scale up report etc.) as well as batch manufacturing and packing records.
8. Ensure product quality is maintained and risk understood by lead investigations of OOSs/trending/action limits etc. for new formulation as well as reformulation with disciplined and evidenced based manner using the principals outlined in quality risk management guidelines by ensuring preventative actions and investigations conclude efficiently and with effective corrective actions.
9. Coordination with various stake holders, project teams, strategic sourcing, QA/QC, manufacturing operations, systems, supply chain, sales, equipment, facilities, project management to plan scale up activities in effective & timely manner.
10. Manage cost efficiency, quality assurance initiatives, budget, capital planning, performance reports, and project management and key performance measurements.
1. Implements decisions necessary to accomplish functions of position or to execute responsibilities.
2. Investigates, reviews, and recommends new procedures, policies and/or technology that would improve or enhance the department’s capability to deliver service and build sales.
3. Communicates delivery of service, processes or product issues that affect Company’s market position or reputation to other Company management as appropriate.
4. Participates in effective management sessions and contributes to discussions regarding Company manufacturing & formula operations, packaging, materials management, and product life cycle management.
Knowledge, Skills, and Abilities Required:
1. Strong written and verbal communication skills and organization skills. Experience in formulations, manufacturing, QA/QC, manufacturing equipment, industrial engineering experience, project management.
2. Experience in multiple delivery forms like tablets, caplets, capsules, soft gels, powder, and pellets. The experience of other dosage form like liquids, topical, sterile dosage form will be added advantage.
3. Experience & understanding of various process technologies (mixing, granulation with rapid mixer granulator process, dry granulation with roller compacter (chelsontor), direct compression process, various milling and drying processes, dosing disk standards, bulk density tests tablets coating (film coating, sugar coating, enteric coating etc).
4. Knowledge as well as application & data interpretation skills with respect to QA/QC, regulatory compliance, lab operations, testing guidelines and processes, stability study, related substances, etc.
5. Minimum 15-20 years relative and similar experience in a fast pace, high growth, multiple facility manufacturing, laboratory, packaging and distribution environment.
6. Verifiable achievement of meeting or exceeding goals in a similar position.
7. Systems, processes and manufacturing operations development experience.
8. Creative problem solving skills.
9. Ability to work independently, leading projects from start to finish with minimal over sight.
10. Good analytical skills and strong attention to detail.
11. Experience leading multifunctional teams and working with outside clients.
12. College degree or advanced degree in business or industrial engineering is a plus.