Job Description

Job Title: Execitive/Sr. Executive/Jr. Manager/Assistant Manager-Upstream Microbial Manufacturing

Job Location: Bangalore

Department: Biopharmaceutical Operations

Job Level: 9/8

About Syngene: Syngene ( ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company\'s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene\' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role: Responsible to Planning and execution of Upstream microbial manufacturing related activities

Role Accountabilities:

• Batch planning in accordance with BMP4 plant occupancy matrix.
• Supervise micro batch schedule and shift planning for day-to-day activities.
• Represent upstream in internal PRM\'s and participate in technical discussions with MSAT and client.
• Supervise the upstream activity from inoculum preparation to transfer of harvest to downstream processing.
• Raise purchase requisition (PR) for capex items.
• GMP compliance in all the manufacturing activities and closure of executed documentation.
• Facilitate and monitor those deviations and CAPA are addressed right the first time and maintain required standards of manufacturing quality systems.
• Perform GEMBA and safety walks for function specific suites as well as common area of bmp4.
• Responsible for handling (receiving, tracking, and providing response) the IPQA observation sheets issued to manufacturing.
• Perform review of the upstream related master batch records and executed batch records.
• Perform review of protocols (study protocols, equipment qualification protocols etc.). Review the executed protocols and provide adequate support for timely closure of the same.
• Collaboratively work with MSAT team to provide input for improvement of products/process.
• Work with maintenance and engineering to troubleshoot process problems and identify solutions that reduce the equipment downtime in a cost-effective manner.
• Facilitate and monitor that the QUOTIF deliverables related to USP are fulfilled as per the defined timeline.
• Participate in SQDECC meetings and drive the assigned element.
• Audit readiness of facility
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted company

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience & Education: B.E/B.Tech/M.Sc (3-12 years)/M.Tech with (3-9 years) of relevant work experience

Skills and Capabilities: * Experience in upstream microbial manufacturing function

• Should have handled upstream related activities and must know to perform tasks related to master batch records
• Must have good communication

Syngene International