Rigorous, independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab.  Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.  Demonstrates strong supervisory skills, excellent communication skills, and contributes to the achievement of company and departmental goals and objectives.  Performs and directs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).  Acts as Study Director for selected assays

• Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to Analytical methods, flow cytometry and/or cell based potency assays.
• Performs scientific review of data packages for cell based and flow assays
• Subject Matter Expert representation on both internal and external discussions.
• As assigned by management, supervises, plans, and reviews operations for assigned staff, including responsibility for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work.
• Effectively communicates and defends science through written and verbal communication.
• Effectively communicates with internal departments to assure that appropriate testing information is effectively communicated and documented
• Provides training on areas of technical expertise and compliance issues relevant to the lab setting
• Conducts and directs assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
• Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
• Prepares protocols, final reports, investigations, and deviations as needed
• Conducts critical review of results and reports data appropriately
• As assigned by Management, supervises personnel and assumes all associated responsibilities
• As assigned by Management, acts as Study Director, Lab Manager, and/or Principal Investigator for specific assays and assumes all associated responsibilities
• Effectively interacts with clients to address scientific and project-related issues
• Maintains a laboratory notebook for Research & Development activities as required; reviews and signs laboratory notebooks
• Follows all general and laboratory SOPs
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required
• May be required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals

• 10+ years of relevant experience or equivalent for Bachelors’, 8+ years for Master’s or 5+ PhD degree in Biological Sciences or related field or equivalent experience.

Knowedge/Skills/Abilities:

• Strong Technical and Scientific knowledge of protein based assays (i.e. ELISA, electrophoresis, etc), flow cytometry and/or cell based potency methods.
• Ability to use proficiently advanced laboratory equipment, such as, but not limited to; Flow Cytometers, automated cell counters, plate readers, HPLC, gel scanners, etc.
• Effective multi-tasking skills and time management required
• Ability to evaluate technical data and record data accurately and legibly
• Ability to accurately and reproducibly perform complex mathematical and statistical calculations
• Ability to use judgment as dictated by complexity of situations
• Ability to understand and follow verbal and demonstrated instructions
• Ability to clearly express and exchange ideas by means of detailed verbal and written communication
• Ability to work effectively as part of a team and exhibit effective interpersonal skills
• Ability to work under limited supervision and to handle problems of a difficult nature
• Proficient in Oral & Written communication skills

Physical Requirements:

• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE.
• Must be able to work in environment with variable noise levels.
• Ability to stand or sit for long periods of time.
• Ability to perform light physical work, lifting up to 20 pounds as needed.
• Ability to crouch, bend, twist, and reach.
• Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.
• Must be able to perform activities with repetitive motions.

Advance Therapies: provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.