QC-Scientist, Bioassay

Just is seeking a motivated and creative scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The new scientist will join a fast-paced, collaborative, and multidisciplinary Quality Control team. This position will be responsible for supporting the process to bring the QC-Bioassay laboratory (BSL2) on-line and will include: overseeing equipment qualification, authoring of SOPs, ensuring compliance with local safety and GxP regulations, qualification of methods to support GMP release and stability assessment of biotherapeutics. As a key senior member of the QC group, the successful candidate will have significant experience in cell-based methods with strong data analysis skills. Experience with immunoassay and qPCR method development /execution is highly desired. The ideal candidate has strong written and verbal communication skill, multitasks effectively, works well independently and in teams.

Responsibilities:

• Help lead the daily activities of the QC Bioassay laboratory in support of large molecule release and stability analysis
• Qualify cell based and other immunoassays for early and late stage biotherapeutics
• Responsible for transfer and validation of methods originating from internal or client Development Laboratories into Quality Control (QC) in compliance with global regulatory requirements
• Provide subject matter expertise during internal project team meetings and interactions with clients
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved
• Author SOPs, Quality analytical methods and LIMS ELN workbooks
• Mentor and train junior staff
• Provide technical support during analytical method transfer into the QC laboratory
• Identify gaps, design collaborative solutions and implement laboratory improvements
• Oversee laboratory investigations, deviations, OOS, and CAPAs
• Implement method lifecycle and method maintenance programs to support bioassay and cell-based methods
• Partner with clients in the design of development and qualification studies, selection and characterization of critical reagents, and method optimization initiatives

Required Qualifications:

• BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of 8 years of GMP industry experience
• Experience in the qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product release / stability testing
• Extensive knowledge of GdPs and GMPs
• Strong oral and written communication skills
• Excellent analytical, technical writing, communication and data management skills
• Extensive experience with the change order process and utilizing a QMS
• Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team
• Ability to understand analytical/technical data
• Good organizational skills with attention to detail
• Ability to interact constructively with co-workers

Preferred Qualifications:

• Utilize Laboratory Information Management System (LIMS) for sample management and data entry
• Experience with SoftMax Pro for data analysis
• Experience with implementation of automated platforms is preferred
• Experience with implementing bioassay methods in a commercial QC facility
• Demonstrated experience in method lifecycle management in a commercial environment is desired
• Experience training QC analysts in method execution and instrument operation and strong technical writing experience (SOPs, Method Validation Protocols and Reports)

The base pay range for this position at commencement of employment is expected to be $75,000 to $105,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.