Responsible for oversight of the Polyclonal, monoclonal, and Pharmacokinetic departments and processes, in accordance with client specifications and / or work orders with the goal of providing consistent, high-quality products and services to our customers with complete, accurate documentation.
Supervisory Responsibilities :
Oversight Project Schedulers throughout the entire company
Position Requirements :
Note : Qualifications are based upon education, resume and / or work experience.
- Good oral and written communication skills (English) and mathematical skills are required.
- Knowledge of Polyclonal and Monoclonal Antibody Generation
- Windows-based computer skills, familiarity with Microsoft Word and Excel.
- Good organizational skills with the ability to manage multiple priorities.
- Experience with GLP / cGMP quality systems and manufacturing operations.
- Ability to give directions, train others, and communicate effectively.
- Knowledge of the metric system.
- Hands on experience with different PK and Toxicology Techniques and Studies
Responsibilities include (but are not limited to) :
- Listing and collaborating with external entities
- Attending and participating in project team meetings and coaching research associates
- Write and revise Standard Operating Procedures (SOPs) and Batch Records (BR) as needed.
- Attend Client Meetings for new development of business
- Collaborating with team members to design experiments and playing a creative role in problem-solving
- Compliance with all Standard Operating Procedures (SOPs) in relation to project management
- Providing routine project updates to internal and external clients for all projects currently being performed
- Perform work in accordance with good manufacturing practices (cGMP) or Good Laboratory Practices (GLP) dependent upon study requirements.
- Creating project reports / laboratory reports and maintaining records as needed
- Assist in preparation of investigation reports as part of the Corrective and Preventative Action (CAPA) program.
- Implement additional training materials and marketing materials for Sales and Marketing.
- Implement and update pricing models as required
- Oversight of all project schedulers in the company in the Polyclonal, Monoclonal and Parmacokinetic studies
- Maintain knowledge of the latest developments in the immunology field.
Education :
Minimum of a Masters Degree in scientific field preferred. Minimum of 5 years’ experience in a scientific field.
Physical Requirements :
- This position is moderately active and requires standing, walking, bending, and moving throughout the lab.
- The employee will need to be able to lift and / or move items up to 50 pounds.
Working Conditions :
- While performing the duties of this job, the employee is frequently standing, walking and sitting.
- The noise level in the work environment is generally quiet with the exceptions of the equipment noise.
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