General Manager – Plant for a leading contract research services company in the area of early drug discovery and development having API manufacturing facility.
Job Location : Hyderabad
Reports to : Vice President – Chemistry
Job Role:
The incumbent will be responsible to spearhead and run the entire operations of the 150KL capacity of intermediate & bulk production plant in Hyderabad. Will be primarily responsible for Production/ Manufacturing of API, Technology development and transfer, Process scale up, complying with internal Quality, Safety and Regulatory requirement. Must have understanding about overall requirement for maintenance of the process equipments and facility.
- Responsible for delivery and passing of audits
- Planning of resources, budgeting for the facility. Should be familiar with DQ, IQ, OQ, documents
- Co-ordination with project, finance, supply chain, R&D, regulatory, QA, QC, EHS and maintenance department for development of systems and procedures in the facility
- Technical scale up, process optimization & validation of multiple products in the facility (Sterile & Non-sterile)
- Responsible to drive cGMP initiatives
Desired attributes:
• Technical
API exposure is a must
Multi-purpose plant exposure required
Strong GMP exposure required
Observing and complying with company Health and Safety Policies
Observing and complying with company Standard Operating Procedures (SOPs)
Knowledge of Custom Pharmaceutical Services (CPS)
Thorough knowledge in calorimetric principles, temperature control modes, physical chemical characteristics, statistical design and data management calculation of consumption coefficients of raw materials for drugs
Initiative for manufacturing cost reduction (like solvent recovery) and implementation of management strategies to meet business requirement
Should be knowledgeable about ICH guidelines and their ramifications
Should have faced multiple audits from FDA, EMA and other regulatory authorities
Should have experience in troubleshooting on purification techniques at pilot and commercial plant scale
• Behavioral
Effective communication skills, Clarity & precision in both verbal & written communication, Good social skills
Strong leadership skills ; ability to work in a team and take responsibility, inspire others
Should be well conversant with multi-tasking
Professionalism : to carry out the job with commitment, respect others viewpoints, maintain values & culture of the organization
Customer satisfaction as a moto. Being sensitive to their needs
Do the job with fullest dedications and take accountability of the work done
Ability to do multi-tasking
Should possess good command over local language (Telugu)
• Educational
PhD /PG in synthetic organic chemistry
• Experience
22-25 years of solid experience, predominantly in API industry
Strong exposure in working in the Multipurpose plant .