Associate Director of Manufacturing-221477

SUMMARY:.

The role focuses on directing the Drug Substance / Drug Product manufacturing, Secondary

Packaging and Material Management functions. This employee is responsible for functions of the

Manufacturing department and supporting Quality Management activities as needed.

This employee must maintain effective employee relationships, compliance to cGMP and other

regulatory and SOP requirements, as well as environmental, health and safety obligations and

company policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 Direct personnel for efficient use of equipment, consumables, and material(s) to produce

quality product(s) following cGMP in accordance with the production plan.

 Evaluate manufacturing systems/ processes, identifying gaps if any, result-oriented

measures for alleviating them and documenting the same.

 Process monitoring and reporting.

 Coordination with contract manufacturer and ensure consistent product supply to

market.

 Planning and participation in new product introduction to facility.

 Budgeting and MIS operation of department.

 Planning production activities; implementing plans with a view to ensure smooth running of

function and timely accomplishment of production targets within the cost parameters. This

includes preventive maintenance, manufacturing, facility and equipment qualification and

validation; as well as secondary packaging and material management activities.

 Responsible for reviewing and approving changes related to equipment, process and

materials in qualified system.

 Responsible for participating in investigations, documentation review and regulatory

inspection to support Quality.

JOB DESCRIPTION

 Responsible for risk assessment of product and processes and identify area of improvement

to reduce risk to acceptable level.

 Support recruitment of department personnel.

 Leading & monitoring the performance of team members to ensure efficiency in production

operations and material management to meet individual & group targets.

 Training team members for enhancement in technical skills like aseptic processing, cGMP

compliance, investigation and data integrity.

 Perform hazard identification in various area and report to EHS team.

 Perform other related duties as required.

REQUIREMENTS:

 Bachelor’s degree in biology or related field, with 15 years of relevant experience or master’s

degree in biology, related field, with 10+ years of relevant experience in a Pharmaceutical/

Biopharmaceutical organization.

 Knowledge of aseptic product manufacturing technology and secondary packaging process.

 Writing and conducting investigations and corrective/preventive actions plans.

 Knowledge of qualification and validation of equipment and processes.

 Experience in performing Risk Assessment (RA) and Failure Mode and Analysis Effect

(FMAE) is a plus.

SKILLS:

 Knowledge of experimental design, data collection, and statistical analysis.

 Communication - Good verbal and written. Ability to collaborate across all levels and

functions.

 Excellent time management skills. Effective in the set-up of priorities and establishing

objectives. Highly flexible and able to organize complex situation and work under stressful

situations.