Technical Manager, Devices & Combination Products
Endo Ventures Ltd.
Operations & Manufacturing
Direct Reports (list)
Reports to (title)
Director, Devices & Combination Products
To be completed by Corporate Compensation:
FLSA (USA only)
Job Summary - a concise overview of the job
The Technical Manager, Devices and Combination Products (DCP) is responsible for overseeing coordination and execution of technical activites related to devices and combination products, for both internaly and externally manufactured products, to support reliable product supply and quality.
The role is responsible for technical support and input into Design and Development (D&D) of new devices and combination products, and for support of in-line devices and combination products. The role will support maintenance of in-line product Design History Files (DHFs), including Design Change.
A key element of the role is to drive and lead DHF development, with the assistance of supporting functions.
This position is responsible for ensuring there are processes & procedures in place aligned to the global Design Controls policy, and that these are being followed to drive compliance with applicable regulations.
The role will work cross-functionally with R&D functions (regulatory affairs, formulation, clinical, medical affairs, and project management), as well as global manufacturing, supply chain, quality, and compliance to execute activities needed to ensure products meet patient needs and current device regulatory requirements.
The role requires working across different geographies and resulting time zones and therefore needs to be flexible in managing their time to work with the different sites.
‘Lives’ the Endo Core Values and Behaviors as they perform their duties in this role.
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.
Branded & Generic Devices and Combination Products Technical Oversight
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Overall DCP Development
- Support design and development of the new Devices and Combination Products. Involves leading internal and external D&D related activities.
- Supporting program execution of Devices and Combination Products, from early concept (exploratory) to D&D, through Design Transfer, launch, and commercialization.
- Writing and/or editing corporate and site level procedures where there are gaps.
In-line DCP Product Support
- Supporting compliant maintenance of commercial devices and combination products. Involves leading internal and external Design Change and associated Design Controls activities.
External DCP Stakeholder Management
- Establishing strong relationships and technical partnerships with CDO/CMO organizations to enable the development and manufacturing of Endo’s Devices and Combination Products, regardless of technology platform.
- Supporting the introduction of new enabling technologies & opportunities that support Endo’s portfolio (R&D and Commercial) objectives.
- Takes ownership of technical device related issues as they arise and works collaboratively to address with the cross-functional team.
- Escalates serious issues in a timely manner.
Technical Assessments, Improvements & Process Capability
- Responsible for technical analysis of DCP related product complaints and recommended CAPAs / Design Changes.
- Provides detailed, thorough technical assessment, analysis, and recommendation for any investigations.
- The functional subject matter expert responsible for the execution of all product specific technical assessments and equipment capabilities, leads the identification of technical issues, troubleshooting and problem solving.
- Identifies opportunities for device and/or product robustness improvements and process capability improvements;
- Leverages local technical expertise and where appropriate works with CMO functional counter-parts to complete specified work.
- Reviews and where appropriate, signs/approves technical documents to support D&D, submission, and on-going manufacture of all assigned products.
- Has experience with combination products and understands the current Regulatory requirements.
- Has direct experience with document support for Regulatory Submissions for combination products
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- BS in Life Science, Pharmaceutical Science, Packaging Engineering, or Chemical Engineering field required, with 8+ years relevant experience in the pharmaceutical or MedTech industry or related field OR
- MS degree with 5+ years experience as noted above.
- PhD with a minimum of 4+ years’ experience as noted above.
- Experience working with Contract Manufacturing Organisations (CMOs), other external vendors, and suppliers, and maintaining successful partnerships.
- Experience in the biotech, medtech or pharmaceutical industry, and with direct experience in R&D and/or technical operations.
- At least 3 years of experience developing and achieving regulatory approval for medical devices and combination products.
- Experience working in a matrix environment, ideally leading projects a distinct advantage.
- Lean Six Sigma qualification preferred (Green Belt / Black Belt)
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Experienced and knowledgeable regarding the drug development process using different therapeutic modalities.
- Experience working in an operations role (e.g., GMP, Design Controls).
- Strong knowledge of applicable regulatory standards for US and/or EU Devices and Combination Products.
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.
- Ability to multitask across multiple programs in a complex and rapidly changing environment.
- Ability to prioritise, and focus on business critical tactical execution.
- Requires excellent interpersonal skills including active listening, effective meeting management, negotiation, and influencing.
- Excellent knowledge base in the medical device technical field, incorporating design and development, Design Controls, and CMC/Manufacturing.
- Working knowledge of regulatory requirements for Devices and Combination Products. Knowledge of Clinical, Formulation and Drug Product an advantage.
- Excellent written and oral communication skills with capability to knowledgably review regulatory technical content in the CMC area.
- Supports a culture of rigorous science and continuous improvement.
- 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.
- 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.
- Must be able to manage their time effectively to work across different geographies (time zones)