Analytical Sciences - Testing - Scientist

Minaris•Philadelphia, PA

About The Position

The Scientist performs basic- to high-complexity biosafety and analytical assays in compliance with applicable cGMP and/or cGLP, CFR, PTC guidelines, and SOPs. The role completes test methods and required documentation, analyzes data, maintains laboratory equipment and supplies, and performs laboratory upkeep. Work is generally completed with minimal supervision, including routine assignments and, with very limited supervision, the design and execution of R&D studies and preparation of research reports. The Scientist may review testing records, author quality events and controlled documents, support training and client interactions, and assist with audits and regulatory inspections. The position contributes to departmental operations and goals and may collaborate with or assist other departments. It requires reliable full-time attendance and professional conduct aligned with company policies and values. The role is performed in a fast-paced laboratory environment with moderate noise and frequent interruptions. Work may involve travel to other locations, including occasional overnight travel, and may require off-shift, weekend, holiday, or overtime duties. The employee works around biological materials, chemicals, and technical equipment and must follow safety requirements and wear appropriate PPE.

Requirements

Bachelor’s degree in Biological Sciences or another science-related major, with 6 or more years of relevant or equivalent experience; alternatively, a master’s degree in Biological Sciences or another science-related major, with 4 or more years of relevant or equivalent experience.
Laboratory experience.
Technical and scientific knowledge of biosafety and analytical assays.
Effective multitasking and time-management skills.
Ability to evaluate technical data and record data accurately and legibly.
Ability to understand and follow verbal and demonstrated instructions.
Clear verbal and written communication skills and the ability to exchange ideas effectively.
Ability to work effectively on a team and demonstrate interpersonal skills.
Ability to work under limited supervision and handle difficult problems.
Proficiency with Microsoft Excel, Word, and Outlook.
Ability to comply with quality, regulatory, safety, procedural, and data-integrity requirements.
Ability to work safely in a laboratory around potential biological, chemical, ergonomic, and physical hazards and follow safety policies and procedures.
Ability to distinguish colors accurately, sit and reach while using computers and standard office equipment, stand for extended periods up to four hours at a time, perform repetitive hand and wrist movements, and use close and distance vision, depth perception, and hand-eye coordination.
Ability to frequently lift and/or move materials weighing up to 20 pounds.
Ability to travel up to 25%, including local and occasional overnight travel, based on business needs.
Ability to work off-shifts, weekends, holidays, and overtime when required.

Nice To Haves

Knowledge of Good Documentation Practices (GDP) and cGMP and/or cGLP.

Responsibilities

Conduct basic- to high-complexity assays and laboratory procedures according to testing records and regulatory guidelines.
Complete testing records and other documentation accurately and in accordance with Good Documentation Practices.
Perform assays using appropriate laboratory techniques and analyze data.
Report observations from ongoing tests to a Scientist and/or Laboratory Manager, and communicate daily laboratory activities with supervisors and colleagues.
Prepare reagents and restock laboratory supplies.
Maintain equipment cleaning and equipment logs.
Mentor analysts and help train new employees; conduct classroom training and serve as an assay trainer or departmental training coordinator.
Work with supervisors to schedule daily activities; the role may have direct or indirect reports.
Maintain the laboratory according to cGMP, CFR, PTC guidelines, and SOPs.
Perform self and peer reviews of testing records and conduct technical reviews of executed records for accuracy and completeness.
Author quality events, test methods, client protocols, SOPs, validation or qualification protocols, and change requests as needed.
Act as a liaison in client meetings.
Prepare and/or submit samples for shipment according to established procedures, as needed.
Support client audits and regulatory inspections, as applicable.
Design, plan, and execute R&D studies under very limited supervision; write R&D reports and ensure data are reported clearly and accurately.
Contribute to departmental operations and goals, collaborate on projects with other departments, and assist other departments as needed.
Comply with FDA and worldwide quality and compliance regulations, established procedures and protocols, training and skill-development expectations, and data-integrity standards.
Exhibit professional behavior with internal and external business associates and align daily actions with company values and culture.
Perform other duties as assigned.