Represent IPR, Pharmaceuticals, Inc in the corresponding forums, support the site technical transfer, production processes and regulatory inspections. Also, as Technology Services Department member will support the Technology Services deliverables as the primary contact for any Technology Services issues that may occur.
Coordinate and conduct process development, process validation and cleaning validation work to assist in process improvement and optimization. Provide technical support for the introduction of new products, technology and/or processes as required.
Typical Accountabilities
- Fully understands the purpose and science of the processes under their responsibility and as a whole.
- Fully knows and understands CQA and CPP of the assigned products and processes. Knows historic and potential failure modes and their corresponding CAPAs.
- Knows assigned products and processes development history. Maintains products story boards.
- Educates team members, including formulation operators, in process requirements and changes.
- Maintains all technical documentation up to date.
- Understands processes, equipment, facilities, and operations holistically.
- Ensures process performance by assessing APRs, in-process results and trends analysis.
- Measures and understands causes of process variations, yield improvements, product losses and any other special situation of assigned area.
- Support daily operations by conducting assessment and troubleshooting activities to resolve technical problems of routine manufacturing operations nature.
- Uses statistical tools to evaluate and pursue to reduce variability and continuous improvement.
- Owns process related investigations and CAPAs and supports all other investigations within the team
- Owns or supports process changes (including change control).
- Owns batch records and revisions for experimental and new Batch Records. Trains members and operators.
- Coordinates projects and activities assigned by the Technology Services Manager.
- Reviews and or approves documents as delegated by Technology Services Manager.
- Leads or represents Technology Services area in company project teams as delegated.
- Designs technically sound experiments in order to identify and work with variables that could possibly affect new and/or current products.
- Develops, executes and reports clearly defined programs to provide documented evidence of validated processes, cleaning procedures and/or equipment.
- Leads manufacture of experimental, validation, stability and/or clinical batches within established time frame.
- Performs and reports physical test results of validation and/or experimental samples.
- Makes recommendations to Technology Services Manager or Manufacturing Operations team members for optimization of manufacturing/cleaning processes to ensure their robustness and thus ensuring their reliability beyond process validation.
- Generates and/or revises SOP’s/CIR’s on an on-going basis to ensure compliance with standards. Provides training in revised SOP’s/CIR’s as required.
- Participates in review of Chemistry and Pharmacy Dossiers.
- Represents the Technology Services Group in the hazard studies conducted and in meetings as delegated by the Technology Services Manager.
- Oversees the manufacture of experimental, validation, stability and/or clinical batches if that is the role assigned.
- Oversees the cleaning activities, experimental, validation, annual monitoring if that is the role assigned.
- Responsible for technical transfers, if required.
Education / Experience
- Fifth year college or university program, sciences related and over seven (7) years related experience and/or training. Thorough knowledge of the pharmaceutical industry with emphasis in manufacturing, process development and validation with experience managing people.
Language
- Fully Bilingual (English & Spanish).
Digital Literacy
- Knowledge of MS Word, MS Excel, MS Project, MS Power Point, among others.
Other requirements
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram models and deal with several abstract and concrete variables.
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals.
- Strong compliance skills.
- Some managerial experience preferred.
Desirable:
- Puerto Rico Licensed Pharmacist desirable.
- Specialized courses in statistics desirable.
- Highly knowledgeable in current Good Manufacturing Practice.
- In-depth knowledge of pharmaceuticals products, manufacturing processes and equipment
- Knowledgeable of validation and other pharmaceutical industry terminology
- Knowledgeable in the theory and application of project management
- Strong statistical background
- Strong compliance background
- Highly adaptable to changes in priorities
- Leadership skills
- Facilitates, good coordinator
- Capable of influencing decisions
- Customer service oriented
- Capable of making recommendations
- Flexible towards company needs
- Capable of working in stressful environment
- Shows self-initiative
Why iPR Pharmaceuticals?
At iPR Pharmaceuticals we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. A culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
iPR Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Date Posted
25-Sep-2024
Closing Date
01-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
Read Full Description