Analytical Sciences - Testing - Scientist

Minaris Advanced Therapies•Philadelphia, PA

About The Position

The Scientist performs basic- to high-complexity biosafety and analytical assays in compliance with applicable cGMP, cGLP, CFR, Points to Consider guidelines, and SOPs. The role completes test methods and related documentation, maintains the laboratory, and performs routine work with minimal supervision. It also designs, plans, and executes R&D studies under very limited supervision and reports findings clearly and accurately. The position contributes to departmental operations and goals, supports training and mentoring, and collaborates with colleagues and other departments. It may involve direct or indirect reports, client interactions, audits, regulatory inspections, and travel to other locations. The role requires reliable full-time attendance and professional conduct aligned with company policies and values. The work takes place in a fast-paced laboratory environment with moderate noise and frequent interruptions. The employee works near biological materials, chemicals, and technical equipment; wears appropriate PPE; and follows safety and regulatory requirements. Travel may be required up to 25%, including occasional overnight travel. Off-shift, weekend, holiday, and overtime work may be required.

Requirements

Bachelor’s degree in Biological Sciences or another science-related major, plus 6 or more years of relevant or equivalent experience; or a master’s degree in Biological Sciences or another science-related major, plus 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.
Ability to communicate ideas clearly in writing and verbally and to work effectively as part of a team.
Ability to work under limited supervision and handle problems of a difficult nature.
Proficiency in oral and written communication.
Proficiency in Microsoft Excel, Word, and Outlook.
Ability to work safely in a laboratory setting around potential biological, chemical, ergonomic, and physical hazards while following safety procedures.
Ability to perform the stated physical demands, including wearing PPE, distinguishing colors, sitting and reaching, standing for extended periods, repetitive hand and wrist motions, lifting or moving materials up to 20 pounds, and using vision, depth perception, and hand–eye coordination for detailed analytical work.
Ability to travel up to 25%, including occasional overnight travel, as business needs require.

Nice To Haves

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

Responsibilities

Conduct basic- to high-complexity assays and laboratory procedures in accordance with testing records and regulatory guidelines.
Complete testing records and other documentation accurately 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 logs and equipment logs.
Mentor analysts and assist with training 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 include direct or indirect reports.
Maintain the laboratory in accordance with cGMP, CFR, Points to Consider guidelines, and SOPs.
Perform self- and peer-review of testing records and technical reviews to ensure records are accurate and complete.
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 in accordance with established procedures, as needed.
Support client audits and regulatory inspections, as applicable.
Recognize deviations from accepted practice while performing routine assignments under written procedures.
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 department operations and goals, assist other departments as needed, and collaborate across departments on projects.
Maintain regular and reliable full-time attendance and exhibit professional behavior consistent with company policies and values.
Comply with applicable FDA and worldwide quality and compliance regulations, follow procedures and protocols, pursue training and skill development, and uphold data integrity.
Travel to other locations as business needs require, potentially up to 25%.
Work holidays, weekends, shifts, or overtime when required.