Upstream Manufacturing Documentation

Designation: Upstream Manufacturing Documentation

Job Location: Bangalore

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

Key Result Areas

Role-specific:

• Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production.
• Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics.
• Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance.
• Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robustness and consistency in compliance with regulatory requirement.
• Prepare technology transfer protocols/descriptions and execute transfer to clinical and commercial manufacturing sites.
• Collaborate with downstream processing, analytical development, and quality assurance teams to ensure seamless integration of upstream processes.
• Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
• Analyze experimental data to draw meaningful conclusions and make data-driven decisions.
• Prepare and present technical reports, project updates, and scientific findings to senior management and stakeholders.
• Ensure that all upstream processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements.
• Prepare and review process descriptions and CMC sections of regulatory documents to support regulatory submissions as required for IND and BLA.
• Develop and implement strategic plans to achieve project milestones and goals.
• Mentor and develop team members to foster a high-performance culture.

 Education

 Master's degree/ bachelor's degree in pharmacy, master's degree in Pharmaceutical Sciences.

Industry Experience

• Minimum 5 -10 years of relevant practical experience in mAbs Upstream process and documentation.

Other competencies required for the role

•  Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.
• Experience with automation and data analysis tools applied for cell culture bioprocessing.
• Familiarity with regulatory submissions and quality systems in the biopharmaceutical industry.
• Strong interpersonal skills with ability to work with internal and external stakeholders.
• Excellent written and verbal communication skills for regulatory documentation and presentations.
• Strong knowledge of bioprocessing principles, cell culture techniques, and scale-up methodologies.
• Perform review of protocols (study protocols, equipment qualification protocols etc.). Review the executed protocols and provide adequate support for timely closure of the same
• Preparation of general upstream related procedures, protocols, risk assessment and BMRs.
• On-time initiation & closure of deviations, investigations, CAPA and change controls.

Safety and DI Responsibilities:

• Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security.
• Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety.
• Understand all necessary safety protocols and always follow the same to ensure safety for all.
• Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals.

Equal Opportunity Employer

 It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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