Lead Associate, Quality Control Microbiology

At Dr. Reddy's "Good Health Can't Wait" 
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. 

Diversity, Equity & Inclusion 
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team.  We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.  

Job Summary 

We are seeking a Lead Associate for Quality Control (Microbiology) for managing daily operations in the quality control microbiology laboratory. The laboratory performs chemical, microbiological, and physical tests on raw materials, packaging components, in process materials, and drug products. Drug products consist of solid dose drug products and semi-solids. The qualified individual will be responsible for leading a culture of safety and quality and assuring compliance with all regulations. The position will also be responsible for leading activities associated with new product development such as method verification, validation, and transfer activities. 

Roles & Responsibilities 

• You will be responsible for managing the overall QC-Microbiology laboratory, overseeing its operations and ensuring efficient functioning. 

• You will be responsible for ensuring employee access to safety training, technical data, and Personal Protective Equipment (PPE). This includes providing well-defined and safe laboratory procedures, maintaining equipment, and continuously monitoring safety protocols. 

• You will be responsible for ensuring compliance with all applicable laws, regulatory agency requirements (e.g., FDA, OSHA, USP), corporate policies, standards, and site procedures. 

• You will be responsible for organizing timely, accurate, and reliable testing of various types of samples such as raw materials, intermediates, and drug products (release/validation/stability). 

• You will be responsible for ensuring test methods are validated, equipment is calibrated and well-maintained, and laboratory data are accurate and retained according to regulatory requirements. 

• You will be responsible for managing environmental and water quality monitoring and testing. 

• You will be responsible for supporting site goals and projects utilizing technical expertise and special studies. 

• You will be responsible for assessing staff performance and providing leadership and communication on all quality control matters with both internal and external customers. 

• You will be responsible for utilizing appropriate statistical and analytical tools to investigate any questionable results. 

• You will be responsible for developing and implementing appropriate corrective and preventive actions for continuous improvement. 

• You will be responsible for maintaining the laboratory in an inspection readiness state, ensuring readiness for regulatory inspections. 

• You will be responsible for providing technical support to manufacturing processes. 

• You will be responsible for making decisions on the acceptability of all test results generated in the laboratory. 

• You will be responsible for developing and implementing a comprehensive training program for laboratory personnel. 

• You will be responsible for planning and executing method development and validation studies, laboratory instrumentation upgrades, and comprehensive test failure investigations. 

• You will be responsible for regularly interacting with laboratory analysts, supervisors, peers, and QC management. 

• You will be responsible for providing analytical chemistry and microbiology support required for in-process controls and process validation. 

Educational qualification: Bachelor’s degree in in Microbiology or related field; Master of Science degree preferred

Minimum work experience: 10 years of experience in the pharmaceutical industry in a technical capacity (laboratory operations, quality, etc.), preferred minimum 5 years of experience in a management role in a laboratory environment

Skills & attributes: 

• Solid experience with method development and validation, stability requirements, and program management.

• Strong laboratory testing skills including mastery of chromatography (HPLC, GC) and other analytical instrumentation. 

• Fully versed in cGMPs, FDA, OSHA, and ICH requirements, and other regulatory agency requirements with knowledge of inspection and process improvement tools. 

• Excellent communication (verbal and written), negotiation, interpersonal, and leadership skills. 

• Excellent problem-solving, decision making, prioritization, and trouble-shooting skills.

• Knowledge of operating budgets and capital project management. 

• Proficient in using SAP, LIMS, CDS, MS Office and other computer programs, and statistical applications. 

• Experience in development and delivery of training programs to professional staff.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

Equal Opportunity Employer 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. 

For more details, please visit our career website at https://careers.drreddys.com/#!/