Senior Analytical Scientist (Full-/Part-time) (all genders)

Your role: 

The Senior Analytical Scientist will have scientific expertise in biologics drug product Lot Release Testing (LRT) for Analytical. This position will ensure projects are carried out with the appropriate scientific and regulatory compliance oversight. They will also provide their scientific expertise to support investigations and client meetings. The Scientist will have the technical expertise to advice and support GMP operations. Responsibilities include reviewing proposals, acting as responsible scientist on complex technical projects, responding to routine assay enquiries, reviewing and monitoring assay performance and lead scientific trouble shooting discussions during investigations. They will maintain an in-depth understanding of Contract Testing Services, BioReliance® services and technical principles as well as advances in the field.

 

The ability to maintain effective working relationships with development services, commercial, SMEs from global CTS and laboratory personnel will be critical for success in the role.

The Scientist will be able to perform the following functions independently, with minimal guidance.

Brief role description:

Lead new assay and technology transfer

STUDY: Acts as a Responsible Scientist for routine and complex assays and as such holds responsibility for the overall conduct of GMP studies respectively

Plans, organises and prioritizes workload ensure testing are conducted timely and effectively issuance of studies Certificate of Analysis (COA)

Ensure routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards

Works with Lab Manager/Manager on testing schedule for laboratory personnel

Works within the laboratory areas providing hands-on support, training, guidance, and mentorship to laboratory personnel

Leads by example, acts as subject matter expert, offers scientific coaching and mentoring to other scientific laboratory personnel

Author, Reviewer and Approval for study and other technical scientific documents, such as amendments, Scientific protocols, Standard Operating Procedures (SOPs), workbooks, technical specification

Designs, directs and leads complex projects related to area of operational expertise

Ensures trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP

Author and reviewer of assay risk assessments related to area of operational expertise

Ensures all assays / processes are in a validated state in line with current regulations

Responsible for maintenance and scientific integrity of routine and non-standard assays methods by monitoring assay performance and advising and implementing on improvements where necessary

Leads process improvements within the laboratory to improve quality and performance

Performs regular housekeeping laboratory check and Health and Safety audits

Host internal Quality Audit representing the laboratory; participate in client or regulatory audit

Responsible on audit observations response through the BioReliance Quality System.

Lead and ensure deviation and Corrective or Preventative Action (CAPA) records in a timely manner

Raise and progress Change Control for new service, testing, assay validation introduction

Acts as scientific consultant to support departmental investigations, client product queries, supplier audits and client/regulatory inspections

Liaises with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects/studies, as required

Acts as point of contact for routine study enquiries

Works with Development Services to review proposals for projects

Write Genetically Modified Organism (GMO) risk assessments.

Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace

Who you are:

Master’s degree or above in Biological Sciences or relevant scientific subject

Minimum 8 years of experience in a scientific laboratory role, ideally within a GMP contract testing laboratory environment

Demonstrable scientific expertise in molecular biology related works

Experience of working in Biosafety Level 2 laboratory

Computer literacy and entry of data into databases (LIMS, ELN, SAP, Oracle, etc.)

Ability to complete documentation (both handwritten and electronic) neatly and accurately

Strategy and business knowledge

Demonstrates customer centricity

Thinks and acts strategically

Can troubleshoot effectively

Understands the business

Operating skills

Puts safety first by adhering to health and safety procedures and actively takes necessary action when encountering unsafe situations

Orchestrates multiple activities in parallel to accomplish goals

Plans workload by assigning tasks appropriately depending on length and difficulty of task

Through effective communication, provides the information people need to know to do their jobs

Experience with some or all of the following technical disciplines:

Liquid Chromatography (SEC, RP, IEX, etc.),

Mass Spectrometry (Intact Molecular weight, Peptide mapping, Disulfide mapping, Glycan Profiling, N-/C-Terminal Sequencing)

Capillary Electrophoresis Methods (CE-SDS, cIEF)

qPCR

Compendial assays, etc.

Pursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacks

Can be counted on to achieve goals, constantly and consistently, pushes self and others for results

Deals effectively with pressure; remains optimistic and persistent, even under adversity

Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact

Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration

Communicates effectively with others

Handles conflict effectively

Department: LS-AS-TG

Job evaluation: Expert 3

TA: Gap Rattimasakol