Study Director

Job Title :
Study Director - Pharmacokinetics and Immunogenicity Assays

Job Location:
Bangalore

Department:
Immunogenicity Research Laboratory - Translational & Clinical Research

About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R& productivity, speed up time to market and lower the cost of innovation.

Key Responsibilities

• Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
• Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival.
• Will be involved in strategic planning for project execution, documentation of data, data analysis, interpretation and presentation of the results
• Ensure to complete the assigned tasks in timely manner.
• Actively involved in preparation of SOPs, protocols, method and reports
• Prepare reagents, buffers and maintain log book for assigned assays
• Interpret results - anticipate and understand the issues related to the assay.
• Participate in, and present data for discussions.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted company

Educational Qualification

• Master's degree or Ph.D in Biological Sciences (Preferably Biochemistry background) or a related field

Technical/functional Skills

• Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols.
• Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable.
• Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines.
• Manuscript writing ability is preferable
• Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc.

Experience

• 6-15 years of experience in immunoassay laboratory. (CRO experience is preferable).

Behavioral Skills

• Ability to work independently as well as with team members
• A strong proactive and independent thinker
• Excellent communication skills - written and oral in English
• Should have good interpersonal skills
• Large degree of flexibility and ability to work under strong time pressure

Equal Opportunity Employer
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.