- Engineering graduate with minimum 15 yrs of relevant experience. Must have direct Biologics Manufacturing Experience.

B.S/M.S/ PhD in Life Sciences, Bioengineering or Biochemical Engineering

- Lead and direct Manufacturing function composed of DS production plants,

- Prepare detailed strategic plans for manufacturing function based on business strategy and serve as a member of Operations Council

- Allocate work and resources to implement plans

- Provide inputs to Production Planning team to create annual/ monthly capacity plans

- Resolve issues and escalations on a timely basis

- Define performance metrics to evaluate manufacturing performance

- Provide guidelines, broad principles and inputs on best practices to team members for production, packaging and warehouse management

- Identify threats from a compliance (quality, regulatory, EHS, labor and other statutory compliances) perspective and design risk-mitigation plans

- In case of major maintenance work / machine breakdown leading to major downtime, coordinate with engineering and commercial teams to create mitigation plans to reduce the impact on market

- Investigate recurrence of deviations/incidents and take decisions after ensuring risk assessment

- Design/redesign systems and processes and create policies of day-to-day processes

- Drive development of risk-mitigation plans for critical and expensive processes

- Create/help create decision trees and other methodologies by which teams can take critical trade-off decisions on their own; manage auditor queries when required during regulatory audits

- Monitor progress on discrepancy investigation, CAPA/ NCs raised during internal and external audits

- Drive sufficient investigation and monitor reporting in the event of incidents, market complaints, returns and recalls

- Prepare/ guide preparation of first draft of Capital project requirements document highlighting the need for creating/expanding a facility, the potential, the scope, etc; seek approval from Operations head / BU head for investment projects

- Conduct routine checks with the Facilities team for new facilities to monitor progress and provide support and guidance on issues, if any

- Identify short / long term system and process improvement requirements for manufacturing function

- Participate / contribute to organization wide initiatives such as safety

- Conduct goal setting, performance appraisals and mentoring / coaching for direct reports

- Collaborate with HR in manpower planning, recruitment activities and identify training needs of team members

- Organize training for team members on new processes / skills when required

- Analyze any engagement surveys conducted by the organization and actively work on improvements / actions identified

- Collaborate and liaison with heads of Quality Control, Regulatory Affairs, Commercial, SCM, Product Development etc.

Desirable candidates should have but not limited to the following experience:

- Proven leadership skills and track records of success in similar leadership roles

- Excellent verbal communication skills

- Demonstrated creative problem-solving skills under resource constraints and time pressure

- Strong technical problem-solving abilities, written and verbal communication skills.

- Demonstrated leadership skills in coaching, managing and mentoring new staff members

- Understanding of quality system

- In-depth knowledge of technical processes and analytics of product development and manufacturing

- Deep knowledge on biologics / biotech

- Knowledge of regulatory framework

- In-depth cGMP knowledge

- Production Planning, QC, QA, Engineering, Facilities, Commercial, Product Development, Clinical, Strategic Sourcing, Staff functions (BPE, HR, Finance)

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