M-F Full Time
Vice President of Process Development
Scope of Function:
1) Manage the development and transfer of Protein purification and protein Bio-Conjugation processes (involving monoclonal antibodies and recombinant proteins) from the client into process development and facilitating its transition into GMP manufacturing.
2) Perform relevant biochemical and biological assays
3) Lead the resolution of technical problems and training of personnel in the Process Development and Manufacturing Groups
4) Responsible for the transfer of purification and bio-conjugation processes to the manufacturing.
5) Effectively manage various projects, including resource allocation and ensuring that client timelines are met within the purification and bio-conjugation groups.
1) Manage all protein purification process development activities as they pertain to GLP and GMP standards. Including chromatography (e.g. affinity, IHC, IEC, Mixed bed, SEC) and filtration processes including sterile filtration, ultrafiltration, Diafiltration, and viral filtration.
2) Manage all protein bio-conjugation development activities pertaining to GLP and GMP standards.
3) Perform final product and in-process assays as required such as ELISA, SDS PAGE, IEF, HPLC, WESTERN, BCA, and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards.
4) Participate in the qualification and validation of processes and as required.
5) Write and execute design input and design output reports, SOPs, and batch records for newly implemented processes.
6) Lead the coordination of activities and communication to assure efficient and timely transfer of projects to the Manufacturing groups.
7) Assist Manufacturing Groups in trouble shooting processes were appropriate
8) Effectively interact and assist other groups within the Development group and the Quality, Manufacturing and Regulatory groups on purification bio-conjugation related matters
9) Interact with Clients and make recommendations and resolutions of processes being developed
10) Communicate project status with Clients, Project Management and Senior GBI Management as needed
11) Effectively manage and motivate lab associates in the purification and bio-conjugation development group
Education and Skills required:
Education: BSc, MSc or PhD in biological or biochemical sciences.
Experience: 6- 10 years relevant industrial experience in proteins and monoclonal antibody purification process and bio-conjugation development and GMP manufacturing, and protein characterization, particularly in the areas of immunology, molecular and cell biology and protein chemistry. Experience in protein and antibody purification and bio-conjugation development, qualification, validation and compliance is required. Experience with early to late stage GMP manufacturing is desirable.
Skills: Expertise in the area of antibody and protein purification and bio-conjugation development. Work independently with little to no direction. Flexible and able to work on multiple projects at the same time. Develop and implement to completion experimental protocols as they pertain to the duties listed above. Effectively manage the employees and the general operation of the lab. Good communication, documentation and computer skills
Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Project Management, Materials Management, Purchasing, Client, Senior Management, Process Development Scientists.
Goodwin Biotech - 8 months ago