Job Description

We are seeking a highly skilled and experienced Bio-Analytical Manager to join our team at a Contract Research Organization (CRO) specializing in Bioavailability/Bioequivalence (BA/BE) studies. The ideal candidate will have a minimum of 5 years of relevant experience in managing bio-analytical operations, with a strong background in BA/BE studies and regulatory audit exposure. As a Bio-Analytical Manager, you will be responsible for overseeing the planning, execution, and reporting of bio-analytical projects while ensuring compliance with regulatory guidelines. Responsibilities: - Manage and lead the bio-analytical team, providing guidance, training, and performance evaluation. - Develop and validate bio-analytical methods in accordance with regulatory requirements. - Plan and coordinate bio-analytical activities, ensuring timely delivery of study results. - Oversee sample analysis, data interpretation, and report generation. - Collaborate with cross-functional teams to ensure smooth project execution. - Monitor and ensure compliance with applicable regulatory guidelines and SOPs. - Liaise with clients, regulatory authorities, and auditors during inspections and audits. - Maintain accurate documentation of all bio-analytical activities and ensure data integrity. - Stay updated with industry trends, regulatory changes, and new technologies in bio-analytical sciences. - Identify and implement process improvements to enhance efficiency and quality. Qualifications and Experience: - Bachelor\'s or Master\'s degree in Pharmaceutical Sciences, Chemistry, or related field. - Minimum of 5 years of experience in bio-analytical operations at a CRO or pharmaceutical company. - Strong knowledge and hands-on experience in BA/BE studies. - Familiarity with regulatory guidelines (e.g., FDA, EMA) pertaining to bio-analytical methods and studies. - Prior experience in managing bio-analytical projects and teams. - Proficiency in analytical techniques such as HPLC, LC-MS/MS, and other relevant instruments. - Excellent understanding of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). - Strong organizational skills with the ability to manage multiple projects simultaneously. - Effective communication and interpersonal skills to collaborate with internal and external stakeholders. - Detail-oriented mindset with a focus on data integrity and quality. If you meet the above qualifications and are interested in joining our dynamic team, please submit your resume and cover letter to sekararunkumar6@gmail.comor What\xe2\x80\x99s app to 9500112999 Only shortlisted candidates will be contacted for further evaluation. Job Type: Full-time Salary: \xe2\x82\xb9720,000.00 - \xe2\x82\xb9960,000.00 per year Schedule:

• Day shift

Experience:

• total work: 5 years (Preferred)

Ability to Commute:

• Chennai, Tamil Nadu (Preferred)

Ability to Relocate:

• Chennai, Tamil Nadu: Relocate before starting work (Preferred)

Work Location: In person Speak with the employer
+91 9500112999