Product Life Cycle (Contract)

PURPOSE

Product Lifecycle is responsible to manage the end to end (E2E) lifecycle of the products in site level, covering the scope of product, process, and cleaning.

MAJOR TASKS

1. Lead all activities new products/innovation, technology transfer, technical changes, roll out and extension products, supply solutions, and regulations/initiatives considering available technologies, capacities, and cost of goods
2. Counter part of internal and external stakeholders to ensure optimum projects timeline and provide advice for projects strategy, including develop and drive improvement initiatives for the portfolio.
3. Lead relations of the site organizations to manage products development projects with the quality registered with the local drug agencies complying with external legal and regulatory requirements as well as Bayer corporate standards.
4. Lead all activities process improvement, local development, and additional variants by implementing quality by design concept including manufacturing and analytical documentation.
5. Support related regulatory activities in collaborated with Local/ Global Regulatory Affairs and
   provide supporting data.
6. Coordinate non-incremental saving as impact of insourcing volume for new products or SKUs for Cimanggis including any other saving due to technology transfer activities.
7. Facilitate the risk assessment of projects and define mitigation plans together with project teams, include responsible for all CAPA and mitigation plan. Escalate issues are needed to ensure course correction prior to off-track events occurring.
8. Lead on successfully NPD, technology transfer, technical changes (process improvement, regulation initiatives) scope of documentation and shop floor work.
9. Lead activities to ensure successful of NPD and Improvement project execution and timeline adherence.
10. Manage project timeline to ensure that all related activities to E2E product development but not limited to product development / product transfer / improvement projects (process and packaging) can achieve the launch target time.
11. Coordinate with related stakeholders to ensure optimum projects timeline.
12. Identify and examine new raw materials used in each formulation projects as part of Supplier Qualification including to ensure availability all required activities including manufacturer audit as per directive.
13. Create all regulatory related documentation and provide necessary supporting documentation to ensure optimal project and product development, discussing and agreeing priorities, timelines and quality, to deliver the best possible formulation and take responsibility for raw materials selection for existing products.
14. Responsible for technical execution as part of E2E activities in their respective portfolio focus.
15. Constantly train her/him-self in matters relating to her/his profession and continuously improve the communication and human relationship skill.
16. Propose to initiate development needs and update the progress through regular one to one discussion (performance-based dialogue).
17. Responsible for the execution of validation process/packaging, cleaning validation, on-product related Validation activities (e.g. equipment)
18. Lead, plan, and execute OPV (On-going Process Verification) and PQR (Product Quality Review) according to valid SOP.

SKILLS & REQUIREMENTS

• Pharmacist or science and food technology background are preferable, with experience in GMP aspect and exposed in all manufacturing aspects with emphasize in formulation development, technology and production, regulatory and quality requirements as preferences.
• Professional experience in pharmaceutical manufacturing, development, manufacturing, quality, and assessment of products.
• Has ability to influence, to build relationships with associations and stakeholders, and to successfully negotiate is required, experienced by project teams with good communication & leadership skills.