PRIMARY RESPONSIBILITIES In general, the Biologics Services Manager is expected to be thoroughly knowledgeable in and will be responsible for devising, managing and conducting all activities supporting Biologics stability and release testing in the Analytical Services Laboratory. He or she will also be expected to take on a more diverse mix of testing assignments and will be expected to play a lead role in more advanced or demanding analytical studies. The Biologics Services Manager will be asked to participate in the preparation and review process of key department documents such as SOPs, forms, worksheets and study protocols. Duties include anticipating and directing the resolution of any problems that may arise during testing, taking the lead in the hiring of new staff, organizing training activities, and conducting annual performance evaluations for the staff. General laboratory duties pertaining to equipment maintenance and calibration, for instance, may also be applicable to this position.
REPORTING LINE This position reports to the General Manager.
SPECIFIC RESPONSIBILITIES Our Promise To Our Customers:
· At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.
Service Responsibilities to Clients:
· Provide scientific guidance in all CMC technical areas, in particular, serve as the large molecule analytical development expert on biologics stability and release testing, test method development and validation and establishment of specifications.
· Ensure that all reasonable client requests pertaining to the conduct of large molecule testing are met in a timely and effective manner.
· Ensure that all client requests for information or time and materials estimates for quotation purposes (or information regarding any of SGS other services) are met in a timely and effective manner.
· Ensure that client complaints are dealt with effectively according to applicable SGS SOPs. Act as staff liaison for large molecule testing performed routinely.
· Participate in departmental and/or company-wise projects designed to improve the nature of SGS client services.
· Work to cultivate long-term relationships with clients based on a combination of technical expertise, scientific knowledge, and professional integrity.
Service Responsibilities to Internal Customers
· Serve as a technical expert providing scientific advice and leadership as needed.
· Ensure that all reasonable requests from the General Manager of SGS Life Science Services pertaining to the conduct of a given test or group of tests are met in a timely and effective manner.
· Ensure that all Analysts working in the Biological Services laboratory have the resources required to successfully complete their studies.
· Notify the corporate QA Department whenever regulatory affairs issues pertaining to testing need to be addressed.
· Notify Contract Review of any special requests or general concerns regarding sample log-in, reporting, and billing activities.
· Play a lead role in Departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.
· Play a lead role in creating and maintaining a positive atmosphere of teamwork throughout the laboratory.
Technical Responsibilities:
· Serve as the US expert in the area of Biologics CMC analytics for clients and staff.
· Interact with the US Biologics Characterization experts to provide comprehensive analytical services for clients.
· Devise, conduct and/or manage all studies related to Biologics CMC support
· Assume and manage the responsibility of all instrumentation dedicated to Biologics (Performance Qualification, maintenance, operation, training)
· Independently author protocols and reports
· Maintain thorough knowledge and understanding of all SOPs pertaining to the laboratory.
· Maintain thorough knowledge and understanding of GMP/GLP and ISO requirements as these pertain to work performed in the laboratory.
· Responsible for performance and/or management of routine large molecule testing requested by clients, as well as certain advanced or specialized studies requested by clients. Duties here include scheduling of time for the test work, proper sample preparation and application of correct test procedures, data collection and recording and preparation of the final report of analysis.
· Train incoming staff
Administrative Responsibilities:
· Adherence to all SGS personnel policies.
· Adherence to relevant SGS SOPs related to the handling of client reporting. Compliance with applicable SGS SOPs related to the handling of client complaints.
Participation in general staff training sessions as these are scheduled
Additional Information: - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required.
- This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign
Education Experience:
M.S. or Ph.D. in Chemistry (or equivalent in experience or training) required. Thorough knowledge of advanced chemistry required. Thorough knowledge of current industry standards and practices regarding testing of health care products preferred. Minimum fifteen years previous relevant analytical laboratory experience in a regulated industry required.
Additional Information: - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required.
- This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
- SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will be called back shortly. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
