Analytical Scientist MSAT

Syngene International Limited•Baltimore, MD

32d•Onsite

About The Position

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 strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. 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 spirit. The incumbent will support the MSAT, Manufacturing and QC teams at Syngene with analytical method transfer, raw material assessment, method troubleshooting and technical support for batch manufacturing and QC analysis. The Scientist will also need to represent Syngene in presenting data to clients.

Requirements

Bachelors in Biotechnology/ Chemical Engineering
Masters in Biotechnology/ Chemical Engineering
Analytical Method transfer skills
Troubleshooting skills
Good team player

Responsibilities

Coordination with cross functional teams to provide the analytical support as per project requirement.
Perform testing in accordance with written procedures for: drug substance and drug product clinical trial materials (bulk or packaged), in-process samples, drug substance and drug product process characterization studies.
Conduct experiments independently for Late-Stage Biologics Products Manufacturing, Process Performance, characterization and stability with optimized effort.
Draft technical documents/reports to share with respective clients.
Review and Participation in Analytical Methods Qualification & Transfer from Analytical Development/Client to Quality Control (QC).
Support for the investigational activities/troubleshooting issues post transfer of the methods.
Responsible for the inventory management for projects.
Handling of deviations and change control.
Own Stability testing and management for Integration as well as scale-up Engineering batches for drug substance, drug product and interim reference standard.
Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
Processing of electronic data using procedures that ensure data integrity and security.
Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
Be a good team player as the role requires coordination within the team as well as with cross functional teams to complete the assigned work as per the project timelines.
Coordinate with various suppliers and vendors as well.
Analytical Methods Monitoring, Process Data Compilation, trending and analysis from engineering and cGMP campaign and authoring of summary reports.
Act as a SME in RP-HPLC/UPLC, SEC-HPLC/UPLC, PA-HPLC/UPLC, CEX-HPLC/UPLC, Peptide Mapping, Glycan analysis, posttranslational modifications, UPLC, Capillary Electrophoresis, Protein quantitation, UV Spectrophotometry, Solo-VPE, understanding on detectors Evaporative Light-Scattering Detectors (ELSD), Charged Aerosol Detector (CAD).
Be responsible for techniques (not limited to) Western Blotting, SDS-PAGE, Plate based Assays Host Cell DNA (HCD), Host Cell Protein (HCP), Residual Protein A (r Pro A) Analysis etc and other Cell Based assays (potency assays, luciferase assays).
Strict adherence to data integrity and traceability.
Overall adherence to safe practices and procedures of oneself and the teams reporting in.
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 labs by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
Compliance to 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.