Process Development Assistant Scientist - Analytical Method Transfer
The Assistant Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. This is an entry-level position that will require training on laboratory instrumentation and appropriate documentation of results to support customer programs.
The AMT group primarily performs Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transitions them into our Quality Control department. The position will mostly focus on learning a subset of analytical techniques and following the procedures outlined in approved protocols, then analyzing and summarizing data. The individual will also be responsible for supporting the group with tasks such as ordering supplies, equipment maintenance, coordinating sample shipments, and preparing buffers. The candidate will be expected to follow cGMP documentation practices.
- Execute method transfers/qualifications/validations based on regulatory guidelines and industry best practices.
- Maintain laboratory instrumentation and assist with vendor visits.
- Develop expertise on a subset of analytical methods, such as HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, and PCR (including quantitative and droplet digital).
- Maintain awareness of project timelines and milestones and openly communicate scheduling challenges.
- Assist in the preparation of reports and PowerPoint presentations.
- Interface with other groups to drive project success, including Analytical Development, Project Management, Quality Control, and Quality Assurance.
- Champion the success and continuous improvement of the group.
- Basic knowledge of biology, chemistry, and/or biochemistry.
- Some practical laboratory skills, such as pipetting and making dilutions.
- Understanding of elementary statistical analyses including standard deviations and linear regression.
- Ability to communicate professionally with colleagues and customers, as needed.
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.
- Good interpersonal skills and the ability to work both individually or as part of a team.
- Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
- Working 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.
- Attendance is mandatory.
- Bachelor's Degree preferably in Chemistry, Biology, Life Sciences or related field; OR
- Associate's Degree preferably in Chemistry, Biology, Life Sciences or related field, with two (2) years of relevant experience.
- Some hands-on experience in a research or industry laboratory.