Senior Officer, Manufacturing Process Operations

Earn Modes; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Earn Modes in India seeks a seasoned manufacturing professional to operate and optimize peptide production processes in GMP environments, with hands-on experience in solid- and liquid-phase synthesis and scale-up.

You will manage equipment, maintain critical batch records, coordinate with QA and stores, and uphold strict safety and environmental norms while driving continuous improvement in efficiency and waste reduction.

Qualifications

• Master’s degree (Organic Chemistry or Pharmacy) preferred.
• 5–7 years in Peptide/API manufacturing operations.
• Hands-on experience with peptide synthesis and process development.
• Exposure to scale-up and regulatory-compliant manufacturing.

Responsibilities

• Operate and monitor reactors, centrifuges, dryers, and other API production equipment.
• Maintain batch records (BMR, BCR, BPR) and equipment logs with accuracy.
• Execute batch operations strictly per SOPs and GMP guidelines.
• Monitor process parameters in real-time to ensure specs and quality.
• Coordinate with QA for document issuance and with stores for material movement.
• Identify deviations and report promptly for corrective actions.

Skills

Peptide synthesis (solid/liquid)

GMP documentation

Process development (peptide pharma)

Scale-up experience

Equipment operation (reactors, centrif

Education

Master's in Organic Chemistry

Master's in Pharmacy (M.Pharm)

Tools

Laboratory equipment operation

In-process testing methods

Job description

Job Description

Essential Functions:

• Strong experience in solid-phase and liquid-phase peptide synthesis.


• Knowledge of hybrid technologies / Molecular Hiving preferred.


• Hands‑on experience in process development of peptide pharmaceuticals.


• Exposure to scale-up processes will be an added advantage.


• Operate and monitor equipment used in various stages of API production such as reactors, centrifuges, dryers, millers, sifters, etc.


• Ensure cleanliness and readiness of equipment before batch charging through visual verification procedures.


• Maintain accurate records, including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, and deviation reports.


• Execute batch operations strictly as per SOPs and GMP guidelines.


• Monitor and record process parameters in real-time to ensure adherence to specifications and quality.


• Report and coordinate with Engineering for any equipment breakdowns during the shift.


• Coordinate with QA for issuance and submission of documents and with the warehouse for material movement.


• Handle raw materials, intermediates, and APIs, ensuring proper storage, reconciliation, and documentation.


• Follow standard procedures for sampling and in-process testing of materials and intermediates.


• Maintain cleanliness and good housekeeping in the designated manufacturing area.


• Monitor utilities in the plant (e.g., steam, vacuum, chilled water) and report abnormalities.


• Monitor and record environmental conditions like temperature, humidity, and differential pressure in clean areas (Level-I, II, III).


• Perform daily verification and calibration checks of weighing balances.


• Participate in periodic equipment cleaning and preventive maintenance.


• Ensure proper handling and disposal of hazardous materials as per environmental guidelines.


• Identify process deviations, malfunctions, or quality concerns and report them immediately.


• Support continual improvement by suggesting ideas for optimization, efficiency, and waste reduction.


• Take mandatory safety and operational training via AIMS software and participate in hands‑on skill-building sessions.


• Adhere strictly to safety practices and use PPE as per company safety protocols.


• Participate in emergency response activities such as managing spills or operational incidents.


• Ensure timely inventory of plant/process-related consumables.

Additional Responsibilities:

• Support implementation of process improvement initiatives and lean manufacturing practices.


• Assist in the qualification and validation of equipment and processes as per regulatory and internal guidelines.


• Ensure readiness of the area for internal, external, and regulatory audits.


• Support investigation and documentation of deviations, change controls, and CAPAs in coordination with QA.


• Participate in cross-functional meetings to discuss production schedules, quality concerns, and improvement plans.


• Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability.


• Train and mentor junior staff/operators on standard procedures and safe working practices.


• Assist in preparation and review of SOPs related to manufacturing activities.


• Ensure adherence to environmental and safety norms in chemical handling and waste disposal.


• Actively participate in safety drills, risk assessments (HIRA), and incident investigations.


• Coordinate with stores for timely availability of raw materials, consumables, and packing materials.


• Report daily production updates to the shift in-charge or supervisor as required.

Qualifications

Master’s degree, M. Sc – Organic Chemistry – Preferred

Master’s degree, M. Pharmacy- Preferred

Experience:

5 to 7 years in Peptide/ API/Intermediate manufacturing operations

Source: Company Career page