Downstream Manufacturing Documentation
Downstream Manufacturing Documentation
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Job Description
Designation: Downstream 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:
- Preparation revision and review of Batch Manufacturing Records (BMR) Packing and Dispatch Record (PDR).
- Issue Checking and Review of Operations documents.
- Preparation and review of Batch Manufacturing Records SOPs PDRs & Protocols.
- Conduct training for all DSP employees for prepared BMRs PDRs and related documents.
- Review of TTDs protocol and Quality Department Protocols related to Operations.
- Investigation of Batch failures in Operations.
- Monitor and follow good aseptic behavior inside BMP5 DSP Facility.
- Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
- Update the batch progress in PRMs and participate in client discussions.
- Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.
- 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).
- Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
- Ensure that all DSP processes are compliant with cGMP ICH FDA EMEA regulatory requirements.
- Develop and implement strategic plans to achieve project milestones and goals.
- Mentor and develop team members to foster a high-performance culture.
Education
Masters degree/ bachelors degree in pharmacy masters degree in Pharmaceutical Sciences.
Industry Experience
- Minimum 5 -10 years of relevant practical experience in mAbs Downstream 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 DSP 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Pls visit us athttps:// to know more about us and what we do.
Employment Type
Full Time
