Job Description

Job Title: Invitro ADME Bioanalyst
Job Location: BangaloreAbout Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spiritMandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company\'s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene\' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:Bioanalytical scientist with expertise in handling LCMS/MS and support ADME screening assays: InVitro assays, MET ID and large molecule analysis by LCMS and in line with business needs.Role Accountabilities:

• Optimization of test compounds and to develop high throughput, fit for purpose LC-MS/MS and HPLC-UV methods to support ADME samples analysis: Formulations analysis, solubility studies, stability studies, In vitro assays, MET ID and large molecule analysis etc.
• Perform analysis of samples generated for the screening of compounds for ADME assays and Processing of different matrices/formulation samples of PK studies with no/minimal supervision
• Excellent written and oral communication skills interacting with internal stakeholders
• Operation, maintenance and troubleshooting of HPLC/ LC-MS/MS system
• Preparation of protocols, reports and templates for responsible activities
• Instrument maintenance, scheduling calibration and maintaining documentation as per regulatory compliance and company policy
• Adhering to safety and quality policies laid by organization
• Delivery of quality data with planning, execution of bioanalytical activities within the team in agreeable timelines
• Development and implementation of high throughput, fit for purpose bioanalytical methods to support invitro ADME samples analysis
• Identification of problem and trouble shooting in quick turn-around time
• Mentoring team members to generate quality data within agreed timelines
• To perform MET ID studies and providing final quality data with interpretation
• Peptide/ large molecule bioanalysis
• Coordination with related invitro verticals to plan the bioanalysis in cassette
• Excellent written and oral communication skills interacting with internal/external stakeholders
• Operation, maintenance and troubleshooting of HPLC/ LC-MS/MS system
• Preparation of protocols, reports and templates for responsible activities
• Instrument maintenance, calibration and maintaining documentation as per regulatory requirements and company policy
• Adhering to safety and quality policies laid by organization
• Formulation analysis data review and trouble-shooting for quicker resolution

Leadership Capabilities: Should be able to guide/mentor the juniors for trouble-shooting and BA method development issues. Should be able to lead a team of 3 to 4 scientistsSyngene ValuesAll employees will consistently demonstrate alignment with our core valuesExcellence
Integrity
ProfessionalismExperience: Minimum 6 to 9 years of relevant industrial experienceDemonstrated Capability:

• Hands-on experience in handling of LC-MS/MS systems is mandatory and experience on HRMS is advantageous
• Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction
• Comprehensive understanding of in vitro ADME assays and technical expertise in trouble shooting the assay samples analysis.
• Basic knowledge on Large molecule and Peptides analysis using LCMS/HRMS
• Should assist/deliver the scientific presentation in departmental journal club and write official Project reports
• Should be equipped with quality policies related to data management and data integrity

Education: M. Pharm in Pharmaceutical sciences/ Relevant master\'s degree in pharmaceutical sciences or instrumentationSkills and Capabilities:

• Good communication skills
• Strong problem-solving and handling skills
• Team Player
• Ability to learn/implement new assay in ADME and Analytical
• Quality compliance skills

Behavioral Skills:

• Ability to manage a team of professionals to deliver quality work within the time frame, train and coach junior scientists, inculcate good work ethics.
• Ability to work with co-workers and outside agencies professionally and tactfully.
• Excellent verbal/written communication and ability to communicate effectively with high transparency is essential.
• Interpersonal skills with an emphasis on working in a team environment to accomplish impactful results.

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.

Syngene International