PURPOSE, OBJECTIVES, FUNCTIONS:
- To support the Principal Scientist in conducting laboratory and pilot plant experiments to develop and improve formulation processes and operations, adhering to customer, regulatory, safety and environmental requirements and guidelines.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Develop prototype liquid and solid protein formulations
- Collect and analyze data, maintaining laboratory notebooks
- Evaluate excipients and vehicles and performs drug-excipient compatibility studies to prepare formulations in-vitro and in-vivo studies
- Evaluate physic-chemical characteristics of proteins (pH stability profile, oligomerization/aggregation, particle size distribution, solid and liquid stability studies)
- Assist in the preparation of technical documents, including specifications, protocols, reports, etc.
- Operate and maintain various scientific instrumentation such as High Performance Liquid Chromotatography (HPLC), Fournier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA), and Differential Scanning Calorimeter (DSC), etc.
- Assist in the planning an executing activities associated with prototype formulation design, process development, scale-up and technology transfer
- Design and develop process improvements that may be of value to the client
- Write and revise protocols, procedures, reports and other process-related documentation as necessary to support the client and manufacturing operations
- Coach staff to maximize team and company goals
- Interpret data, prepare reports and present results to the project teams
- Manage technical oversight over purification operations
· Generate novel approaches to the development of commercially viable purification processes
- Identify and report any preventative maintenance needs
- Identify potential hazards either safety or ergonomic
- Place purchase requisitions for laboratory members
- Identify and suggest and test any process improvements
- Coach, counsel and discipline direct reports as appropriate
- Requires a BA/BS in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline or equivalent work experience and 6-8 years directly relevant experience in the biopharmaceutical environment
- MS in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline or equivalent work experience and 4 years directly relevant experience in the biopharmaceutical environment
- PhD in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline with minimum of 2 years directly relevant experience to the biopharmaceutical environment
- Required to sign a confidentiality and a non-compete agreement
- Knowledge and experience with proteins, with a wide variety of parenteral systems (syringes, vials, freeze drying, cold chain, etc.) utilized for formulation and filling of recombinant protein products and with the current practice of protein formulation and associated analytical techniques (MS, HPLC, SDS-PAGE, etc.) is desirable
- Must have strong analytical skills and experience with purification
- Must have appropriate laboratory experience/training as well as a strong mechanical aptitude
- Exhibit strong leadership abilities and strong interpersonal skills
- Must also be independent, multi-tasking and results-oriented with a hands-on attitude in a fast-paced environment
- Knowledge and experience with purification techniques and associated analytical techniques gained through industrial experience
- Experience with cGMPs desirable
- Excellent written, oral and organizational skills
· Responsible for completing assigned tasks by due dates
· Responsible for training curriculum on current SOPs
· Responsible for documenting, reviewing and/or verifying laboratory data
· Responsible for the initiating and completing investigations in a timely manner
· Responsible for compliance to company’s Quality Policy Manual
· Responsible for compliance with company’s safety policies
· Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook
- Responsible for compliance of Corporate Code of Conduct
PHYSICAL REQUIREMENTS AND ENVIRONMENTAL CONDITIONS:
- Majority of day spent on feet in the laboratory or clean rooms
- Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position
- Must be able to lift/push/pull 30 pounds
- Limited use of hazardous chemicals
This description is not intended to provide an all inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. T his job description is not a contract of employment and does not change your status as an at-will employee.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...