Associate Manager Documentation

Syngene

10-15 years

₹28,00,000 – ₹36,00,000 per annum

Bengaluru

10 Aug. 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Manager – Documentation (Upstream Bioprocessing)

Location: Bangalore, Karnataka, India (On-site)
Job Type: Full-Time
Job Grade: 7-1 (Associate Manager)
Date: 18 Aug 2025

About Syngene International

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE) is a leading integrated research, development, and manufacturing services organization, serving global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. With 4,500+ scientists and 1.9 million sq. ft. of world-class facilities, Syngene partners with leading multinationals including Amgen, BMS, GSK, Baxter, and Merck KGaA to accelerate innovation and ensure robust, secure, and cost-efficient solutions across discovery to commercial manufacturing.

Job Summary

The Associate Manager – Documentation will lead the upstream process group with a focus on monoclonal antibody (mAbs) and fusion protein production. The role requires leadership in upstream process design, documentation, technology transfer, regulatory support, and compliance, ensuring high-quality, cGMP-compliant bioprocesses.

Key Responsibilities

Role-Specific

Lead upstream process development for cell culture-based biologics production (mAbs, fusion proteins).
Oversee end-to-end activities in upstream process development, ensuring scalability and regulatory compliance.
Manage technology transfer for scale-up and GMP manufacturing; collaborate with CMOs for efficiency and supply assurance.
Design and execute risk-based process characterization studies (CPPs & CQAs).
Scale-up bioreactor processes from lab to pilot/commercial scale with robust, reproducible performance.
Prepare and execute technology transfer documentation for clinical and commercial manufacturing.
Collaborate cross-functionally with downstream, analytical, QA, and regulatory teams for seamless integration.
Ensure cGMP, ICH, FDA, and EMEA compliance in upstream operations.
Support preparation and review of regulatory documentation (IND/BLA CMC sections).
Mentor and develop upstream teams to build technical depth and high performance.

Documentation & Quality

Review protocols (study, equipment qualification, etc.) and ensure timely closure.
Develop upstream-related procedures, protocols, risk assessments, and BMRs.
Lead deviations, investigations, CAPA, and change control processes.
Ensure timely, accurate regulatory documentation and presentations.

Safety & Data Integrity

Ensure adherence to EHSS, POSH, Data Integrity, and IT security policies.
Follow PPE and lab/plant safety requirements; proactively report near-misses and incidents.

Qualifications

Education

Master’s or Bachelor’s degree in Pharmacy or Pharmaceutical Sciences.

Experience

10–15 years of relevant industry experience in Upstream Process Development (mAbs) and documentation.

Technical Competencies

Strong expertise in cell culture techniques, scale-up methodologies, and upstream bioprocessing principles.
Experience with automation, bioprocess data analysis, and regulatory submissions.
Proficiency in preparing regulatory documents and CMC sections for IND/BLA.

Behavioral Competencies

Excellent problem-solving, communication, and leadership skills.
Ability to work effectively in fast-paced, cross-functional, and collaborative environments.
Strong stakeholder management skills (internal & external).

Salary Range

₹28,00,000 – ₹36,00,000 per annum (estimated, based on Associate Manager roles in Biopharma R&D & Manufacturing in Bangalore).

Why Join Syngene

Opportunity to work with global pharma & biotech leaders.
Exposure to end-to-end R&D, process development, and GMP manufacturing.
Career growth and technical leadership in biopharmaceuticals.
Inclusive, diverse, and safety-first work culture.

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Associate Manager Documentation

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