Job Description

JOB DESCRIPTION

Designation: Manager

Job Location: Bangalore

Department: Formulation Development - Pharmaceutical Development

About Syngene

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene\'s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Responsibility Summary:
Responsible for Supervision, documentation, upkeep, facility maintenance, cGMP compliance for production and packaging operations at formulation manufacturing facility for human injectable dosage forms.

QMS, MSTG/MSAT, Investigation and manufacturing of Parenteral/Injectable processed by aseptic and isolator technologies for liquid, lyophilized and dry powder injectable presentations for regulated markets in the Pharmaceutical and Biotech industry

Primary Responsibilities:

• Experience in Injectable manufacturing Operations is must.
• Knowledge of Packaging development, packing process validation, finalization of change parts, evaluation of Packaging materials, and machines.
• Change parts qualification, new packing equipment qualification.
• Technical knowledge and hands on experience on Isolator
• Technical knowledge and hands on experience on Aseptic Operations
• Technical knowledge and hands on experience on Equipment Qualifications
• To ensure Quality and compliance and facility readiness for client visit/ audits.
• To ensure logbooks update, log sheets tracking and review of facility documents.
• Experienced in regulatory compliance requirements (e.g. USFDA, MHRA, WHO, TGA).
• Initiation of Change control for procedural revisions, changes in facility.
• Procurement activity for consumables, instrument & equipment qualification.
• Preparation of URS, review of DQ, IQ, OQ. Preparation & execution of PQ.
• To ensure preparation & revision of SOP/IOP/EOP/ECC
• Supervision, execution, planning & execution of clinical batches & registration batches manufacturing and packing activities.
• To ensure cGMP training on a scheduled manner to all concerned personnel.
• To ensure compliance to quality system procedures & documentation as per organizations requirements.
• Hands on experience knowledge of Track-wise, SAP and Documents management system.
• Client communication and interactions responses.
• Preparation of RFPs and support to development team
• Technology transfer for Small molecules and Large Molecules at IFF

People management, Learning & training:

• To review contract people daily work.
• To ensure training to all on procedures.

Secondary Responsibilities:

• To ensure and implement procedures to target Zero Incidents.
• To ensure preparation of Risk Assessment
• To ensure proper Housekeeping and to circumvent EHSS Violations.
• PPE compliance.
• To support Project Execution.
• Proven track record of successful manufacturing process development for high potent and general formulations covering Liquid and Lyophilized Injection, PFS, FFS, Eye drops, Gel / Creams, Hormones, liquid suspensions and biotech products like therapeutic proteins and monoclonal antibodies.
• Manage investigation & resolution of Technical and Quality issues for Sterile and Non-sterile formulations encountered during routine and stability studies to enable secured product supplies
• Experience in handling Process Engineering Tools: Collaborative mixing analysis and scale-up tools like Mixit (CFD tool) and DEM tool.
• Experienced in Technology Transfer (exhibit batches, scale up, site transfer, product life cycle management, external site transfer); acknowledged for simplifying plant processes and practices along with document practices
• Expertise in Quality Management System (QMS) like handling of Deviations Change Controls & Root Cause investigations and ensured continuous improvement by identifying the gaps in the QMS systems
• Resourceful in project planning and execution: Skilled in Trouble Shooting Projects, Process Improvement projects, Process Time Reduction Projects, and Cost Savings Projects
• Build Digitally native and a \'Predictive\' organization by develop best in class platform for products using Advanced Analytics (FULCRUM: AI/ML), Collaborative mixing analysis &scale-up tools like Mixit (CFD) & DEM tool.
• Root Cause Analysis Activities like Quality Investigations, Market Complaints, CAPA Studies and propose a technical Resolution of OOS/ OOT, Incident and Deviations.
• Handling Trouble Shooting Projects, Process Improvement projects, Process Time Reduction Projects, and Cost Savings Projects.
• Lead new product implementation for sterile from Manufacturing POV by coordinating with R&D and Quality to ensure smooth product registration and launch.
• Scientific Support to build product and process robustness to improve process capability along with process stabilization.
• Build predictive capability with respect to Sterility Assurance using advanced data analytics tools like MVDA/AI/ML
• On time, technical resolution using software\'s (eg. Minitab, Fulcrum) to reduce CoLO and CoPE.
• To provide support in designing trials/DoE if required for defining the problem and finding the root cause.
• Develop MSTG lab for performing specialized tests (solid and liquid material characterization) as an input to perform software-based model simulation studies. (Leading MSTG lab)
• Conduct and coordinate training program (Classroom and OJT) on various Process topics along with Investigation Skills, Aseptic Techniques, Data Integrity, and Inspection Readiness. Coordinate with external and internal trainer for facilitating learning. (Leading Sterile Academy) \xe2\x9e\xa2 Ensure site readiness for regulatory cGMP inspections (USFDA, MHRA, ANVISA, WHO etc.) and global audits / visits (Corporate audits).
• Preparation of Protocols, Risk assessment and reports of Trouble Shooting Products.
• Execution of Assessment and Feasibility batches for identification of Root cause.
• Identification of new technologies for process improvement.
• Perform Data analysis of key Quality Systems and represent them in site and global management meetings and deploy improvement strategies.
• Harmonization and best practices sharing with team

Educational Qualification: M. Pharm or B. Pharm having 15-18 years of experience in pharmaceutical manufacturing and packing operations is required.

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.

Syngene International