Process Development Senior Scientist - Analytical Method Transfer
The Senior Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. The individual should possess broad scientific knowledge of bioanalytical techniques that are used to assess viruses and proteins as well as strong technical writing skills.
The AMT group is a protocol-driven group which will primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The position will predominately focus on creating analytical method protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QA group and client. The candidate will be expected to follow cGMP documentation practices.
- Design and execute method transfers/qualifications/validations based on regulatory guidelines and industry best practices.
- Perform assays to evaluate the accuracy, precision, specificity, linearity, robustness, and detection/quantitation limits of analytical methods.
- Act as a technical lead for client programs and provide updates and professional recommendations to external customers.
- Maintain a thorough understanding of project timelines and milestones and openly communicate scheduling challenges.
- Prepare and/or review technical documents including protocols and reports.
- Review data within the team.
- Evaluate methods for cGMP readiness and perform gap analyses.
- Interface with other groups to drive project success, including Analytical Development, Project Management, Quality Control, and Quality Assurance.
- Troubleshoot method challenges in a creative and controlled manner.
- Provide expertise and training to junior scientists.
- Champion the success and continuous improvement of the group.
- Performs all other duties as assigned.
The ideal candidate will have considerable knowledge and expertise relevant to viral and protein analytics and protocol-based method evaluations.
- Hands on experience in several of the following technical fields: HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, PCR (including quantitative and droplet digital), viral titer assays.
- Experience with CFR 21 part 11 compliant software packages (such as Empower, SoftMax Pro).
- Experience working with a team of scientists in a direct or matrix environment.
- Experience working in or interfacing with a regulated cGMP environment.
- Understanding of data analysis tools and relevant statistical methods.
- Demonstrated ability to professionally relay analytical data and conclusions both visually and verbally.
Required Skills & Abilities:
- Builds credibility within the group by performing high quality work and identifying opportunities to improve workflow.
- Ability to operate efficiently and productively with minimal supervision.
- Strong oral and written communication skills.
- Good interpersonal skills and the ability to work both individually or as part of a team
- Demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
- Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting/standing, along with some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Attendance is mandatory.
- Ph.D. preferably in Chemistry, Biology, Life Sciences or related field, with one (1) year of relevant experience; OR
- Master's Degree preferably in Chemistry, Biology, Life Sciences or related field, with six (6) years of relevant experience; OR
- Bachelor's Degree preferably in Chemistry, Biology, Life Sciences or related field, with eight (8) years of relevant experience.
- Some experience as a lead or supervisor.
- Experience in pharmaceutical or biotechnology industry.
- Experience working in a contract manufacturing or testing organization is preferred.