Specialist, API Sourcing
3 weeks ago
Endo Operations Limited Dublin, County Dublin, Ireland
2 days ago Be among the first 25 applicants
The Specialist, API Sourcing assists and supports Portfolio Management, R&D, Analytical and Regulatory teams by liaising between potential sources of Active Pharmaceutical Ingredients (APIs) for internal and external Research and Development (R&D) purposes. The role works cross functionally with Portfolio Management, Project Management, R&D, Analytical R&D, Regulatory, Business Development and Legal to support strategies, gain alignment and drive API timelines. The role is specifically responsible for documentation management and updates as they relate to R&D, Analytical and Regulatory support.
Key Accountabilities- key outcomes/deliverables, the major responsibilities, and % of time
API Sourcing- Assist in sourcing (access market, determine API availability, identify key manufacturers/suppliers & determine market price) Active Pharmaceutical Ingredients (APIs) for targeted or potentially targeted products identified for internal or external development through use of database resources, meetings with suppliers and attendance at pharmaceutical conventions, as required. (30%)
- Keep abreast of the market and provide market intelligence to management on potential API or dosage form opportunities, meeting Endo's criteria for internal R&D development based on market and patent analysis, leading to key future business.
- Specifically responsible for scheduling annual international conference schedules (DCAT and CPHI).
- Provide support through R&D product life cycle.
- Ensure that all groups and/or partners have the data and materials to support on time and quality ANDA filings.
- Assist Supply Chain with transition of project post filing.
- Maintain and update data within Sharepoint, including potential source detail and market pricing for APIs to maintain competitive edge within the market for new product opportunities.
- Request new vendor set up or modifications in SAP, as required, while adhering to required Change Control procedure; request new internal code set up for SAP entry, ensuring all required information is provided.
- Request and maintain technical data packages from API suppliers for access by Regulatory, R&D and Quality individuals, including sending/tracking vendor questionnaires.
- Request and maintain all documentation required to support new ANDAs to be filed by Endo Regulatory team; including management of sending/tracking Specification Agreements for each Endo monograph, through ANDA filing.
- Special projects as assigned/directed by Director of API Sourcing.
- Bachelor's degree or equivalent in a scientific or other related discipline with at least 5 years related work experience within the pharmaceutical industry working closely with R&D, Business Development and Manufacturing; or an equivalent overall level of knowledge based upon previous work experience.
- Purchasing experience is a plus.
- Knowledge of GMP and Regulatory requirements to support ANDA filings.
- Knowledge of JDE a plus.
- Highly organized with an ability to work independently.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
- Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
- Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- 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.
- Office required due to confidential nature of work.
- Limited domestic and international travel required.
- Minimum annual remuneration: 51,000 Euro
- Location: Building 1 Minverva House, Simmonscourt Road, Ballbridge, Dublin, Ireland D04H9P8
- 40 hours per week
Associate
Employment typeFull-time
Job functionOther
IndustriesPharmaceutical Manufacturing
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