Process Development Associate Scientist - Analytical Method Transfer
The Associate 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 experience with several 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 primarily focus on executing analytical method protocols, summarizing data, coordinating instrumentation needs, finalizing test methods and ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success. The candidate will be expected to follow cGMP documentation practices.
- 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.
- Maintain laboratory instrumentation and assist with vendor qualifications.
- Develop expertise on a subset of analytical methods and participate in method troubleshooting activities.
- Maintain awareness of project timelines and milestones and openly communicate scheduling challenges.
- Assist in the preparation of technical documents including protocols and reports.
- Finalize analytical test methods; route documents for approval within MasterControl.
- Interface with other groups to drive project success, including Analytical Development, Project Management, Quality Control, and Quality Assurance.
- Provide assistance and training to other scientists/analyst within Process Development and Quality Control since QC does not have scientists.
- Champion the success and continuous improvement of the group.
- Performs other duties as assigned.
The ideal candidate will have knowledge and expertise relevant to viral and protein analytics and protocol-based method evaluations.
- Some hands on experience in the following technical fields: HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, PCR (including quantitative and droplet digital), viral titer assays.
- Knowledge of CFR 21 part 11 compliant software packages (such as Empower, SoftMax Pro).
- Knowledge of cGMP regulations.
- Understanding of data analysis tools and relevant statistical methods.
- Demonstrated ability to professionally relay analytical data and conclusions both visually and verbally.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
This position will not have direct reports.
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 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.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to lift 50 pounds on occasion and 25 pounds regularly.
- Ability to wear PPE.
- Attendance is mandatory.
- Master's Degree preferably in Chemistry, Biology, Life Sciences or related field; OR
- Bachelor's Degree preferably in Chemistry, Biology, Life Sciences or related field, with one (1) year of relevant experience; OR
- Associate's Degree preferably in Chemistry, Biology, Life Sciences or related field, with 4 years of relevant experience.
- Experience in pharmaceutical or biotechnology industry.
- Experience working in a contract manufacturing or testing organization is preferred.