Manager, Biologics (Biophysical Characterization)

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Job Description

The Principal Scientist, Biologics will act as the subject matter expert and operate in the lab as an independent researcher. You will conceive, implement, analyze experiments to produce fully independent data. You will be responsible for method development, validation, and transfer of methods used in the testing of biopharmaceutical products or raw materials. This position will be the primary contact for the client(s). You will be responsible for complex decision-making and re-evaluation, optimization, and troubleshooting of methodologies as requested and will lead technical discussions with clients. In addition, this position will provide guidance to and oversee the analysts regarding their performance and will manage small to mid-sized projects to ensure completion in a timely manner to the satisfaction of both SGS and the client. With global visibility and a clear vision for revenue-producing activities, the Principal Scientist will be held accountable for the team's delivery.

• Perform the development and validation of analytical testing procedures for drug substances and drug products
• Write protocols, drafts methods, and technical reports
• Coordinate method transfers between clients and SGS.
• Provide expert technical support to clients, internal and other SGS groups
• Make complex decisions and perform activities relating to method development and validation of analytical testing procedures
• Ensure that equipment is maintained properly; perform calibrations and qualifications as required
• Participate in and lead investigations for OOS, OOT, and deviations. Participate and execute CAPA
• Executes experiments, following the company’s SOPs, Deviations, and Change Control programs and cGMP guidelines
• Keep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in a timely manner
• Duties here include preparation for testing by using good time management skills for each assigned task, adequacy of testing documentation, proper application of test procedures, proper techniques for data capture and recording, and preparation of the final report of analysis
• In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure, and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate
• Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer
• Keep the work area clean and organized; immediately clean up spills, dispose of waste according to laboratory procedures and place used glassware in designated locations for cleaning
• Perform other assigned lab duties as requested.
• Utilizes advanced analytical techniques to identify root causes and determine courses of action
• Inform the Department Head if the assigned work order cannot be satisfactorily completed within established scheduled time and quality-of-work expectations.
• Ensure that all client requests for analytical testing information or time and materials estimates for quotation purposes (or information regarding any of SGS's other services) are met in a timely and effective manner
• Develop, implement, and maintain systems to ensure that established parameters governing turnaround time and quality expectations are met on a consistent basis in the Analytical Services Laboratory.
• Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective manner
• Ensure that client complaints are dealt with effectively according to applicable SGS SOPs
• Play a lead role in departmental and/or company-wide projects designed to improve the nature of SGS client services
• Represent Company and Company policies as needed during client visits and regulatory agency inspections
• Provide technical support and feedback to clients and other SGS groups
• Liaise with clients to establish project timelines and with SGS management to assess resource requirements
• Coordinate method transfers between clients, the Research and Development gr