Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group's own R&D facilities and through strategic partnerships with manufactures from around the world.
JOB SUMMARY:
The Senior Product Launch Planning Associate will report to the Supply Chain Senior Director and work closely with Business Development, Supply Chain, Sales/Marketing, Regulatory and Project Management to execute against the company's strategic priorities and operational plan. Primary job duties will be to define the launch plan, taking input from both internal and external stakeholders to achieve the desired working capital and market share targets.
DUTIES AND RESPONSIBILITIES:
Collaborate with cross functional team in supporting the Project Management activities for New Product Launches during the launch phase. Will support Business Development and Project Management in the advanced planning regarding CMO and API supply and launch readiness.
Work closely with Business Development and Sales for new launches on achieving target market share. Coordinates with Supply Chain to provide the CMO with a 12-24 month rolling supply forecast and Purchase Orders. Provides clarity on launch strategy to include Process Validation (PV) strategy recommendation, freight/logistics/DSCSA defined and compliant, timely ordering of raw materials and start of manufacturing to ensure on-time launches that are launch ready on Day 1 and are on-time and in-full quantity (OTIF).
Liaise with Project Management, Strategic Alliance, Regulatory and Quality to ensure product development and post approval projects are in line with BPI objectives, and that the Supply Plan corresponds to the timelines of open projects.
Support Sr. Director, Supply Chain on new projects with existing partners, collaborate with Business Development, Product Development, Supply Chain and Regulatory, for developing the right business model complementing the partner capabilities. Support cross-function team in project scope and commercial discussions to ensure timely filing, approval and launch (post-approval).
Participate in routine and monthly new product launch discussions internal and external. Responsible for escalating any Operations issues to management.
Support packaging design, specification and labeling requirements related to market-specific drug product presentation serialization requirements.
Support the review and approval process for labeling artwork, ensuring impact of labeling, printed component implementation, modification, revision is properly assessed and implemented.
ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE:
Bachelor's degree or commensurate experience.
3-5 years of operations pharmaceutical experience with knowledge of supply chain: forecasting, inventory control, order scheduling, and customer service
Proficient in MS Office, experience in MS Excel and analytical reporting
Enterprise resource planning (ERP) experience is a plus but not required
Excellent organizational and teamwork skills
PREFERRED SKILLS:
Excellent interpersonal and collaborative skills and the ability to work independently and effectively in a highly dynamic environment.
Effective oral and written communication skills.
Highly adaptive and flexible to accepting new ideas, people and procedures.
Strong analytical skills to make quantitative projections.
Must demonstrate effective listening, sound judgment, be well organized, take initiative, be flexible, and work well under pressure.