Senior Manager Technical Operations
Endo Ventures Limited
Operations and Manufacturing
Direct Reports (list)
Reports to (title)
Senior Director Technical Operations
2nd October 2019
To be completed by Corporate Compensation:
2nd October 2019
Job Summary - a concise overview of the job
The Senior Manager Technical Operations is responsible for directing the coordination and execution of all technical operations activites for all external manufactured products to ensure reliable product supply and quality; including technical analysis and assesment of the CMOs manufacturing capabilties and equipment process excellence and product 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.
The incumbent must be capable of managing a number of complex projects and provide assistance and support to other member of the technical operations team as required.
The incumbent will foster effective cross-functional working relationships and be an effective collaborator with internal and external groups. The incumbent will apply innovative manufacturing technology and quality-by-design principles and execute on key projects to achieve business objectives. The incumbent will manage scale-up activities and provide support during process validation and continuous process monitoring for marketed products. This position requires working closely with Business Development, Internal and External sites, Supply Chain, Finance, Regulatory Affairs and Quality Assurance teams.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
- This position reports to the Senior Director, Technical Operations
- Subject matter expert for manufacturing process, process equipment capability
- Lead a number of complex projects including new product launches, API qualification, tech transfer and process improvement as per business requirements
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
- Subject Matter Expert (SME) responsible for the execution of all product specific technical assessments and equipment capabilities
- Lead the identification of technical issues, troubleshooting, problem solving and CAPAs for significant issues at CMOs.
- Provide technical support, when requested, for deviations, change control master batch record review, APR review, customer complaints and so on where requored to support development, submission, and on-going manufacture of all assigned products
- Identify and lead multiple, complex technical projects including technical transfers, new product launches, API qualification and so on.
- Lead multifunction teams across projects and process to resolve any issues and identify innovative approaches to resolving issues.
Process / Continuous Improvement
- Identify and lead improvement efforts to improve production efficiencies, reduce cost of goods and optimise cycle times.
- Directs the identification of opportunities for process robustness improvements and process capability improvements at CMOs; leveraging local Technical expertise and working with CMOs functional counter-part to complete specified work
- Partners with external and internal cross functional teams to ensure projects are completed on time and ensuring adherence to corporate objectives and goals
- Presents at meetings with internal and external representatives. May lead briefings and technical meetings for internal and external representatives.
- Provides technical guidance to team members when troubleshooting manufacturing processes
- Participate in harmonization of business processes across the technical organization implementing best practices accordingly
- Remain current with regulatory requirements that impact technical operations.
- Stays current with emerging technology within industry
- Acts as a technical or functional expert and leverages this expertise across own and related disciplines. Demonstrates a high level of industry knowledge & business expertise.
- Interprets, administers, and may establish policies, processes, and procedures that may affect sections or disciplines and subordinate work units. Recommends and implements changes to policies & procedures that affect immediate work units.
- Assignments are primarily objective oriented, but may be defined in terms of activities. Work is reviewed in terms of meeting departmental and organizational objectives and timelines.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- BS in Chemical Engineering, Chemistry,. Pharmacy or related scientific field with a minimum of 10 years relevant experience in the pharmeceutical industry or related field. Or advanced degree ) with a minumum of 7 years experience
- Familiarity with cGMP, DEA, and FDA regulations and SUPAC and ICH guidelines. Position requires an understanding and experience with pharmaceutical manufacturing processes and equipment. Experience withvarious dosage formulations is required
- Experience implementing and evaluating contracted work with vendors and suppliers and maintainging successful partnerships
- Experience working in a matrix organization
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Understanding of the current pharmaceutical technologies and manufacturing equipment; technology transfer and scale-up, testing, validation, and packaging. Knowledge of requirements for post approval changes, relevant ICH, SUPAC and current process validation guidances needed. Knowledge and Understanding of formulation development of solid/liquid dosage forms
- Must possess knowledge of cGMPs and SOPs applicable to position. 21CFR Part 210 and 211 and Part 11
- Strong knowledge of Supply Chain Operations.
- Knowledge and understanding of pharmaceutical manufacturing, compounding, production processes, and packaging operations, equipment and facilities
- Knowledge of statistical and mathematical principles
- Knowledge and demonstrated application of Process Excellence tools(6S, Visual Factory, Lean Manufacturing and Six Sigma) and methodologies
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Demonstrated analytical and problem resolution 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
- Must possess good interpersonal skills,
- Demonstrate strong collaboration capability
- Effective verbal and written communication skills
- Must demonstrate the ability to multi task by performing multiple complex projects and tasks simultaneously
- Experience in sterile manufacture and/or combination products would be considered advantageous.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Some travel will be required.