The successful candidate is able to
apply prior experience and knowledge to successfully perform in
a laboratory environment under regulated conditions.
Essential Position
Responsibilities:
Proficiently perform Molecular biology techniques
such as purification of nucleic acids and quantitation assays
(e.g. qPCR or ddPCR)
Able to qualify and proficiently perform
Ligand-binding assays (e.g. ELISA / MSD) applicable to
Pharmacokinetic, Biomarker and Immunogenicity studies is a
plus.
Independently performs service tasks as directed.
Independently performs analysis for validation
and sample testing in support of GLP studies.
Assists with method transfer, development, and
troubleshooting in support of GLP studies.
Responsible for data interpretation and provide
data summaries for studies.
Performs study activities to meet the regulatory,
GLP, protocol, and SOP requirements.
Maintains the experimental records and raw data
in a secure way to protect the integrity of the data.
Reviews and checks data generated by other staff
as assigned.
May represent group in cross departmental
initiatives.
Works safely with potentially hazardous
substances, exercise universal precautions.
Functions effectively in a team-oriented
atmosphere and work independently when necessary.
Knowledge of Watson LIMS and cell culture
techniques a plus.
Capable of navigating and updating electronic
inventory systems.
Maintains a clean lab and work environment.
Perform other duties as assigned.
Additional Position Requirements:
May perform operational duties in areas of
appropriate experience and training.
Mentoring and training junior staff
Become a Subject Matter Expert on process or
equipment
Must be able to lift 40 pounds.
Additional Requirements:
Perform general laboratory support functions such
as supply inventory, shipping procedures, or data maintenance.
Ability to multi-task and produce quality
analysis while working under the pressure of strict deadlines.
Overtime, weekend and holiday work as required.
Effective written and oral communication skills.
Work requires some standing and sitting for long
periods of time, including working within a laboratory hood
and at standing bench top.
Repetitive work with hands.
Qualifications:
BA/BS in Biological or Physical Sciences and at
least 2 - 3 years of relevant experience, MS in relevant field
and at least 1-2 years of relevant experience.
Level of position will be commensurate with
experience.
Knowledge of GLP regulations and other regulatory
guidelines.
Excellent communication skills, both oral and
written, and strong organizational skills.
Proficient in the use of basic computer
applications such as MS Word and Excel.
