Associate Manager documentation

Designation: Associate Manager

Job Location: Bangalore

Job Grade: 7-1 (Associate Manager)

The Company

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and 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 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

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 TTD’s, 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 PRM’s 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

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

Industry Experience

• Minimum 10 -15 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.