Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The Technical Operations Manager is responsible for managing the coordination and execution of all technical operations activities for internally and externally manufactured products to ensure reliable product supply and quality; including technical analysis and assessment of internal and external manufacturing capabilities, process robustness, designing, implementing and executing FMEAs. Scope of work includes manufacturing and packaging commercial operations, technology transfers, process validation, new product launches, second source qualifications and cost savings initiatives. Working with combination products and in particular Design Controls and DHF development and maintenance.
This position requires working closely with Business Development / Strategic Sourcing, Supply Operations, Research & Development, Regulatory Affairs, Logistics, and Quality Analytical Operations teams. This position requires effective communication with Third Party Suppliers on technical issues.
Job Description
Scope of Authority:
- Subject matter expert for manufacturing process, equipment, and raw materials.
- The role may require some supervisory responsibilities.
Key Accountabilities:
Leading Tech Transfers & NPLs
- Leads and drives product Technical Transfers and new product launches (post-filing through to commercialisation).
- Responsible for project budgets and managing changes to project scope with relevant stakeholders.
Technical Assessments & Improvements
- Subject matter expert (SME) responsible for the execution of all product specific technical assessments and equipment capabilities.
- Leads the identification and resolution of technical issues, troubleshooting and problem solving.
- Supports other functions as necessary for technical input.
Technical Capability
- Reviews, writes and where appropriate, signs/approves technical documents (e.g. MBRs, MPRs, Validation Plans / Protocols, Change Controls, FMEAs, Shipping Studies, Cleaning Validations) and CMC documents to support development, submission, and on-going manufacture of all assigned products.
- Leads the cross-functional team on significant investigations.
Change Control, Complaints, Investigations & CAPAs
- Responsible for technical analysis of product complaints and recommended CAPAs/changes.
- Provides detailed, thorough technical assessment, analysis, and recommendations for any manufacturing investigation.
- Provides Impact Assessment for Change Controls.
Process Capability
- Identifies opportunities for process improvements and process capability improvements, leveraging local technical expertise and working with functional counter-parts to complete specified work.
Qualifications
Education & Experience
- BS degree in Chemical Engineering, Chemistry, Pharmacy or related scientific field with a minimum of 8+ years’ relevant experience in the pharmeceutical industry or related field OR
- MS with a minimum of 5+ years’ experience as noted above OR
- PhD with a minimum of 4+ years’ experience as noted above.
- Previous experience with cGMP and FDA regulations, and SUPAC and ICH guidelines.
- Previous experience with pharmaceutical manufacturing processes and equipment.
- Experience with formulation and process development of oral solid-dosage, liquid, gel, ointments, sterile injectable products and other dosage forms is required.
- Experience with various dosage formulations is required.
- Experience working with Contract Manufacturing Organisations (CMOs), other external vendors, and suppliers, and maintaining successful partnerships.
- Experience working in a cross-functional, matrix organization.
- Knowledge and experience of aseptic (sterile) manufacturing highly desireable.
- Knowledge and experience of Lean Six Sigma is desireable.
Knowledge
- Thorough understanding of the current pharmaceutical technologies and manufacturing equipment; technology transfer and scale-up, testing, validation, and packaging.
- Advanced knowledge of requirements for post approval changes, relevant ICH, SUPAC and current process validation guidance needed.
- Extensive knowledge and understanding of formulation development of sterile injectable dosage forms, e.g. Pre-fillable syringes, Ready-to-Use IV Bags, Vials. Solids/liquids/gels advantageous.
- Deep understanding of the current pharmaceutical technologies and manufacturing equipment; technology transfer and scale-up, testing, validation, and packaging.
- Knowledge and experience of Combination Products and Design Controls an advantage.
Skills & Abilities (Competencies)
- Demonstrated analytical and problem solving skills for technical issues.
- Ability to independently evaluate, assess and initiate action; recognition of positive and negative impacts of actions, decisions, other market forces on business and people.
- Ability to change the thinking of, or gain acceptance of, others in sensitive situations and drive in the organization within current location and potentially other divisions or subsidiaries when necessary.
- Is able to write clearly and succinctly in a variety of communication settings and styles.
- Writes clearly on both technical and non‐technical topics.
- Ability to define problems, collect data, establish facts, and draw valid conclusions and deal with several abstract and concrete variables.
- Ability to plan and manage multiple projects simultaneously.
- Excellent communication skills including the ability to speak clearly and persuasively in positive or negative situations; listen and gain clarification; respond to questions; demonstrate effective presentation skills; and write clearly and informatively.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs work flows and procedures.
- Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
- Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
- Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Physical Requirements
- Travel (up to 25%) may be required.
