Title:  Associate Director, Supply Chain

Primary Objective

The Associate Director will support the manufacture of Drug Product (fill finish, device assembly and secondary packaging) of biologics product. Responsible for activities range from tech transfer, technical process studies, process validation activities, data analysis to handing change controls, deviations and troubleshooting. Writing and reviewing of DP/Device Assembly/FG validation-related documents and key CMC sections of regulatory dossiers (different countries) are also required for this position. In addition, also represent and support supply chain team from commercial and clinical supplies of Biologics.       

Major Duties/Responsibilities

• Lead and oversee the operational activities at DP/FG/Device Assembly CMO’s; scheduling of batches, commercial manufacturing and testing of DP
• Responsible to achieve on-time in-full manufacturing of DP/FG/Device Assembly in compliance with approved dossiers in collaboration with Quality Assurance, Regulatory Affairs, and Analytical teams
• Serve as DP Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven development and optimization of biological processes
• Review and approve master batch records, change controls, and deviations, CAPA to ensure GMP compliance and operational success
• Preparation and review of documents such as CPV reports, risk assessments, technical reports, validation documents, deviation reports and regulatory modules
• Responsible for Tech Transfer and Process Validation into Commercialization
• Plan and forecast budgets, analyzing variances for production and development testing and execute the day-to-day financial activities in accordance with procedures and contracts.
• Support the supply chain process for clinical and commercial programs to align with functional leaders and senior management on demand and supply plans.
• Coordinates supply activities with Clinical Operations, Technical Operations, Regulatory, Quality Operations, and other departments as necessary to develop optimal supply strategies. 
• The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans.
• Supporting post launch market surveillance of the product
• Other duties as assigned

Education

B.E./BTech, MS or Ph.D. degree in (bio) chemical engineering, biotechnology

 Professional Experience

• Doctorate degree with 1-3 years of related experience - or- Master's degree and 3-5 years of related experience - or- Bachelor's degree and 5-7 years of direct experience in Biologics Drug Product GMP manufacturing
• Experience in cGMP Biologics Drug Product is a must
• Knowledge of statistical tools like minitab/JMP for data analysis is required
• Knowledge of analytical testing methods and impact on product quality specifications is advantageous.

 Skills & Abilities

• Excellent interpersonal and communication, presentation skills
• Excellent organizational and project management skills, work well under pressure
• Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams.
• Ability to influence internal and external stakeholders through scientific justifications
• Ability to thrive in a small group setting with limited administrative support

The presently-anticipated base compensation pay range for this position is $146,500 to $162,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.