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Product and Technology Lead
- Haleon (Oak Hill, NY)
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**Hello. We’re Haleon** . A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
About the role
As Technical Product Owner effectively and independently own and lead all elements of the Product Lifecycle for the site's products.
Role Responsibilities
+ Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
+ Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s), including cleaning of products: Technical, Product Control Control Strategy to standard work as batch manufacturing instructions as per the principles), Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and as appropriate appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
+ Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialization of new products from R&D, andsubsequent transfers to other sites. The Product Owner is responsible for the completion of all TRA, MMI (site specific), batch records and recipes for all NPIs and Technical transfers.• Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approachfor the product.
+ Responsible for assessing the product quality impact of any change that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of primary changes impacting API material properties (primary product owner), assessment of impact of API/excipient changes on the dose secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc
+ Provides leadership and establishes key relationships within site across , Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D.
+ Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
+ Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
+ Leads Product Technical Review PTRT) if Product Owner for drug product.
+ Identifies, develops and trains successors for the role, and coaches others in their area , ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.
+ Review opportunities for batch processing improvementsand waste reduction. Work with a cross functional team toimplement as required.
_Why you?_
Basic Qualifications:
+ Bachelor’s degree in engineering (Chemical, Mechanical, Electrical or a related field scientific field)
+ 5+ years' experience in a process, manufacturing, project, or R&D engineering position
+ Experience in Pharmaceutical/FMCG or other regulated industry
+ Experience working in a manufacturing environment, including manufacturing process and equipment.
Preferred Qualifications
+ Detailed knowledge of relevant dosage forms including unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallization, isolation, drying and particle size reduction), plant equipment and analytical testing. Awareness of device/packaging processes.
+ Level 1 Facilitator for TRAs (‘Proficient’ level as defined by the TRA competency framework)
+ Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).
+ Knowledge of regulatory environment, particularly in markets where product is commercialized.
+ Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
+ Experienced in technology transfer, with an understanding of the product development process and manufacturing equipment
+ Able to evaluate potential innovative technology areas relevant to product
+ Thorough knowledge of GMP and EHS requirements
+ Demonstrated in-depth knowledge of Quality by Design and risk management approaches
+ Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA
+ Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders
+ Demonstrated ability to mentor operational staff and support functions
+ Project management skills
+ IT Skills: MS Office, SAP, Power BI
_Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering._** **_The salary range for this position is: $102,146 to $140,451 annually plus a 12% Performance Bonus._
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.
Accommodation Requests
If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to [email protected]. Please include the following in your email:
+ Use subject line: ‘Haleon Careers: Job Accommodation Request’
+ Your Name and contact information
+ Requisition ID and Job Title you are interested in
+ Location of Requisition (city/state or province/country)
+ Description of specific accommodation you are requesting
+ Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.
Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.
Hello. We’re Haleon. A new world-leading consumer healthcare company. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
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