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 Associate Director leads the process development, process validation, scale-up technology transfer, and manufacturing / packaging function; including technical analysis and assessment of the CMOs manufacturing capabilities, and equipment process excellence, product robustness, and designing, implementing and executing FMEA. Has in-direct oversight of the Process Engineers that perform activities for R&D pipeline product projects, including planning and coordination of engineering batches, registration batches, scale up to commercial production size, through product and cleaning validation. This position also supports technical assistance on previously developed and launched products.
Plans, develops, and directs operations with resources enabling the safe, compliant and opportune manufacture of product. Supports the development of new products through registration and commercialization. Participates on cross-functional teams to address specific problems, facilitate discussion and research, and enable operation to become more efficient.
The incumbent must be capable of managing a number of increasingly complex projects where analysis of situations or data requires an in-depth evaluation of various factors.
Promotes a positive working environment, and acts as a mentor to other members of the Technical Operations team. Collaborates with internal and external cross-functional teams to ensure projects are completed on time and adhere to strategic goals and objectives. Proactive leader who is accountable to provide expert technical opinion to management to assist in formulation and execution of strategic planning to ensure the operation is positioned to meet or exceed industry and regulatory expectations. Ensures operations are carried out with a consistent approach and on a timely basis in line with the strategy as well as applicable regulatory requirements.
Job Description
The Technical Operations Associate Director leads the a team accountable for process development, process validation, scale-up technology transfer, and manufacturing / packaging; including technical analysis and assessment of the CMOs manufacturing capabilities, and equipment process excellence, product robustness, and designing, implementing and executing risk assessments. Has direct oversight of a team of Tech. Ops members that perform activities for R&D pipeline product projects, including planning and coordination of engineering batches, submission batches, scale up to commercial production size, through product and cleaning validation. The Technical Operations Associate Director, will be accountable for the performance and development of their team of direct reports. This position also supports technical assistance on previously developed and launched products.
Plans, develops, and directs operations with resources enabling the safe, compliant and opportune manufacture of product. Supports the development of new products through registration and commercialization including Sterile Injectables (IV Bag, PFS, Vial) and Oral Solid Dosage forms (Oral suspensions, Capsules and tablets), ensuring safety and efficacy for intended use. Participates on cross-functional teams to address specific problems, facilitate discussion and research, and enable operation to become more efficient.
The incumbent must be capable of managing a number of increasingly complex projects where analysis of situations or data requires an in-depth evaluation of various factors.
Promotes a positive working environment, and acts as a mentor to other members of the Technical Operations team. Collaborates with internal and external cross-functional teams to ensure projects are completed on time and adhere to strategic goals and objectives. Proactive leader who is accountable to provide expert technical opinion to management to assist in formulation and execution of strategic planning to ensure the operation is positioned to meet or exceed industry and regulatory expectations. Ensures operations are carried out with a consistent approach and on a timely basis in line with the strategy as well as applicable regulatory requirements.
All incumbents are responsible for following applicable Division & Company policies and procedures.
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
Community Guidelines:
1. Be respectful. Everyone who visits our page should feel comfortable and respected.
2. If we see a comment that violates anything in the following list, it may be removed.
• Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional.
• Comments that are excessively repetitive and/or disruptive to the community.
• Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter.
• Comments that appear to be medical advice.
We reserve the right to remove a reply for any reason at any time.
3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088.
Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.
