Technical Director, Devices & Combination Products - Remote
Endo International plc
Dublin Dublin
Ireland
Engineering
(No Timezone Provided)
We're looking for a candidate to fill this position in an exciting company.
Responsibilities
% of Time
Overall DC P Development Strategy & Individual Program Expertise
- Support design and development of the new devices in support of Endo's innovative pipeline, with a priority on speed-to-patient, product quality, compliance with regulatory requirements, and cost. Involves leading internal and external technical development activities, including supporting strategy development and implementation.
- Implementing technical strategy and program execution of Devices and Combination Products , supporting from early concept (exploratory) to design and development, through tech transfer, launch, and commercialization.
35 %
In-line DCP Oversight
- Ensuring compliant maintenance of commercial devices and combination products. Involves leading internal and external Design Controls activities .
35%
Internal DCP Team Management
- Provides overall leadership to the DCP organization.
- Identifies, facilitates, and supports opportunities to enhance functional capability expansion and growth.
- Ability to influence and inspire scientists/engineers /technicians in the organization, as well as be a strong mentor and coach .
- Reports directly to the Executive Director, Technical Operations and engages to discuss program status, challenges and opportunities.
30 %
External DCP Stakeholder Management
- Identifying and forming strategic technical partnerships with CDO/CMO organizations to enable the development and manufacturing of Endo's Devices and Combination Products , regardless of technology platform.
- Introduction of new enabling technologies and identification of external opportunities that support Endo's portfolio (R&D and Commercial) objectives.
- Takes ownership of issues as they arise and works collaboratively to address with the cross-functional team.
- Builds strong relationships with the Third Party partners .
Qualifications
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 1 2 + years relevant experience in the pharmaceutical industry or related field OR
- MS degree 1 0 + years' experience as noted above.
- Experience in the biotech, medtech or pharmaceutical industry, and with direct experience in R&D and /or technical operations.
- At least 5 years of experience developing and achieving regulatory approval for medical devices and combination products.
- Experience leading a technical organiz ation in an environment requiring effective engagement with key stakeholders.
- At least 5 years' leadership experience, including matrix project management.
- Lean Six Sigma qualification preferred (Green Belt / Black Belt)
Knowledge
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 dif ferent therapeutic modalities.
- Experience leading or working in an operations role (e.g., GMP, Design C ontrol s).
- Strong knowledge of applicable regulatory standards for US and EU Devices and Combination Products.
Skills & Abilities
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 .
- Applying strategic and business thinking, while also ensuring tactical execution and operational excellence.
- Requires excellent interpersonal skills including active listening, effective meeting management, negotiation, and influencing. Managing group dynamics will also be required .
- Ability to address poor performance in a professional manner and reward a nd recognize high performance.
- Excellent knowledge base in the medical device technical field, incorporating design and development, Design Controls, and CMC/Manufacturing .
- Working knowledge of r egulatory 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.
- Propagates culture of rigorous science and drives continuous improvement.
- Able to build an effective organis ation by attracting, retaining, and developing high-caliber scientists/engineers. Strong mentor and coach; invests time in helping others enhance their skills and perform at a higher level.
Technical Director, Devices & Combination Products - Remote
Endo International plc
Dublin Dublin
Ireland
Engineering
(No Timezone Provided)
We're looking for a candidate to fill this position in an exciting company.
Responsibilities
% of Time
Overall DC P Development Strategy & Individual Program Expertise
- Support design and development of the new devices in support of Endo's innovative pipeline, with a priority on speed-to-patient, product quality, compliance with regulatory requirements, and cost. Involves leading internal and external technical development activities, including supporting strategy development and implementation.
- Implementing technical strategy and program execution of Devices and Combination Products , supporting from early concept (exploratory) to design and development, through tech transfer, launch, and commercialization.
35 %
In-line DCP Oversight
- Ensuring compliant maintenance of commercial devices and combination products. Involves leading internal and external Design Controls activities .
35%
Internal DCP Team Management
- Provides overall leadership to the DCP organization.
- Identifies, facilitates, and supports opportunities to enhance functional capability expansion and growth.
- Ability to influence and inspire scientists/engineers /technicians in the organization, as well as be a strong mentor and coach .
- Reports directly to the Executive Director, Technical Operations and engages to discuss program status, challenges and opportunities.
30 %
External DCP Stakeholder Management
- Identifying and forming strategic technical partnerships with CDO/CMO organizations to enable the development and manufacturing of Endo's Devices and Combination Products , regardless of technology platform.
- Introduction of new enabling technologies and identification of external opportunities that support Endo's portfolio (R&D and Commercial) objectives.
- Takes ownership of issues as they arise and works collaboratively to address with the cross-functional team.
- Builds strong relationships with the Third Party partners .
Qualifications
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 1 2 + years relevant experience in the pharmaceutical industry or related field OR
- MS degree 1 0 + years' experience as noted above.
- Experience in the biotech, medtech or pharmaceutical industry, and with direct experience in R&D and /or technical operations.
- At least 5 years of experience developing and achieving regulatory approval for medical devices and combination products.
- Experience leading a technical organiz ation in an environment requiring effective engagement with key stakeholders.
- At least 5 years' leadership experience, including matrix project management.
- Lean Six Sigma qualification preferred (Green Belt / Black Belt)
Knowledge
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 dif ferent therapeutic modalities.
- Experience leading or working in an operations role (e.g., GMP, Design C ontrol s).
- Strong knowledge of applicable regulatory standards for US and EU Devices and Combination Products.
Skills & Abilities
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 .
- Applying strategic and business thinking, while also ensuring tactical execution and operational excellence.
- Requires excellent interpersonal skills including active listening, effective meeting management, negotiation, and influencing. Managing group dynamics will also be required .
- Ability to address poor performance in a professional manner and reward a nd recognize high performance.
- Excellent knowledge base in the medical device technical field, incorporating design and development, Design Controls, and CMC/Manufacturing .
- Working knowledge of r egulatory 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.
- Propagates culture of rigorous science and drives continuous improvement.
- Able to build an effective organis ation by attracting, retaining, and developing high-caliber scientists/engineers. Strong mentor and coach; invests time in helping others enhance their skills and perform at a higher level.