Position Overview
Responsible for performing routine building, utility, and equipment maintenance, repairs and installations in compliance with company policies and procedures.

Specific Duties:
1. Performs routine troubleshooting and repairs of mechanical control systems.
2. Performs manufacturing equipment changeovers, when needed or required.
3. Complies with all company equipment and regulations.
4. Complies with all company policies and procedures.
5. Maintains maintenance work areas in a clean and orderly manner.
6. Supports department goals for output and efficiencies.
7. Installs power supply wiring and conduit for newly installed machines, equipment such as conveyors, and programmable controllers.
8. Diagnoses malfunctioning apparatus such as motors, lighting fixtures, replaced damaged or broken wires and cables.
9. Tests malfunctioning machinery and discusses malfunction with the Facilities Engineer.
10. Replaces faulty electrical components of machines such as relays, switches and motors, and positions sensing devices.
11. Diagnoses and repairs or replaces faulty electronic components such as printed circuit boards.
12. Replaces electric motor bearings and rewires motors.
13. Diagnoses and replaces faulty mechanical, hydraulic and pneumatic components of machines and equipment.
14. Facility related repairs.
15. Occasionally works on some plumbing, installing compressed air, nitrogen and water lines.
16. Perform preventive maintenance on different pieces of equipment and Utilities Systems such as HPW system, Clean Steam Generator, CIP, PH neutralization system, chiller system, HVACs Units, Refrigerator and freezers, Incubators and stability chambers, etc.
17. Understanding of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
18. Production equipment operations and maintenance practices.
19. Standard Operating Procedures for equipment operations including safety rules and regulations.
20. Basic electrical and pneumatic control systems.
21. Mechanical aptitude and basic mathematics.
22. Complying with all Company policies and procedures.
23. Complying with all Company safety rules and regulations, recognizing hazards and taking appropriate corrective action.
24. Understanding and following written and oral instructions.
25. Establishing and maintaining cooperative working relationships with individuals contacted in the course of work.
26. Ability to write routine reports and correspondence.

Position Requirements:
High School Diploma or equivalent with minimum 10 years or College degree with minimum 5 years of industry experience
Methodical time management skills for performing multiple tasks
Computer skills including MS Windows and MS Office.
Ability to interact effectively with GBI personel.
Must have good communication skills, including verbal and written acumen.
Good Manufacturing Practices(GMP) training

Position Overview
The Project Manager (PM) becomes involved with the Sales Manager and the Client once the sale has been closed (at times the PM may help the Sales Manager close). The PM then becomes the primary GBI contact with the client. All issues regarding contract negotiation, production schedules, schedules for all testing (incoming cell line, in process and final product), management of customer expectations, the timing of billing points and the successful handling of the project become the responsibility of the PM.

Specific Duties:
1. Write, negotiate, and distribute Statements of Work (SOW) and corresponding Amendments to it.
2. Initiate project Bills of Material and assure timely follow up and coordination with Manufacturing, Purchasing and Materials Management.
3. Hold periodic project team meetings as required to ensure thorough company-wide understanding of the project.
4. Facilitate fast, accurate communication, both in-house, and with clients by participating in Production Coordination and Operations Meetings.
5. In conjunction with Finance and Manufacturing, submit the details for each project to Finance to make the monthly Work In Process adjustments to the financial statements.
6. Initiate and track Project billing point forms.
7. The prime contact with the client and with all GBI departments.
8. Work with GBI QCQA to establish testing schedules for Projects, and to ensure that test Articles are submitted and test results are received in a timely fashion.
9. Plan and execute frequent (at least weekly) client communication system to track and communicate promise dates, project status and invoicing points.
10. Provide input to GBI Cash Flow and Sales Forecast projections as necessary.
11. Contribute data as necessary to Sales and Marketing databases for mailings.
12. Work in concert with GBI Sales Team to provide service and information for prospects, new clients, and existing clients.
13. Maintain a centralized archive of Statements of Work, Quotations, and Non-Disclosure Agreements.
14. Perform other tasks as necessary and as directed.

Position Requirements:
Bachelor of Science Degree.
Three (3) years laboratory/manufacturing experience with biological products.
Project Management Professional (PMP) certified, or working toward certification.
Methodical time management skills for performing multiple tasks.
Computer skills including MS Windows, MS Office, MS Project, ACT.
Working knowledge of relevant scientific, processing and regulatory compliance issues.
Ability to interact effectively with GBI personnel as well as be the clients’ in-house representative and empathetic to their requirements.
Must have good communication skills, including verbal and written acumen.

Scope of Function:
Responsible for development and qualification of relevant biochemical and biological assays. Lead in the resolution of technical problems and training of personnel and assist in the transfer of assays in the Quality Control groups.

Specific Duties:
1. Develop and 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.
2. Record development and qualification activities and results in appropriate notebooks.
3. Write and execute qualification protocols and reports for newly developed assays.
4. Write SOPs and train Quality Control group on newly developed assay processes.
5. Assist in leading the coordination of activities and communication to assure efficient and timely transfer of projects within QC.
6. Assist QC group in trouble shooting assays as needed.
7. Effectively interact and assist other groups within the company on assay related matters.
8. Assist in interacting with Clients and making recommendations and resolutions for assays being developed.
9. Maintain laboratory inventories and equipment.
10. Assist in communicating project status with Clients, Project Management and Senior GBI Management as needed.
11. Keep abreast with new technologies and products that may aid in the assay development process.
12. Multi-task multiple projects.


Position Requirements:
Education:
Bachelor’s Degree or Masters Degree in biological or biochemical sciences.

Experience:
5 to 10 years relevant laboratory experience in assay development and protein characterization, particularly in the areas of immunology. Experience in writing/editing GLP/GMP SOPs.

Experience in assay qualification and validation is a plus.

Skills:
Must be able to work semi-independently with some direction. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Good communication, documentation and computer skills

Scope of Function:
1. Primarily responsible for the development of new protein purification, protein modification and bio-conjugation manufacturing processes.
2. The characterization of intermediates and final products.
3. Responsible for the analyses of process step efficiency (e.g. purity, step loss, step yield, etc.).
4. The transfer of new or existing processes and procedures to manufacturing.
5. The resolution of technical problems and the monitoring of ongoing manufacturing campaigns.

Specific Duties:
1. Downstream Process Development activities (cGLP and cGMP). Including chromatography (e.g. IEC, HIC, affinity and size exclusion chromatography, etc.) TFF sterile filtration and nanofiltration as applied to the purification and modification of antibodies and other proteins.
2. Addressing scale-up issues of process steps.
3. The development of filtration processes including Sterile Filtration, Ultrafiltration, Diafiltration, Microfiltration, and viral (Nano) Filtration.
4. Develop and perform in-process and final product testing as required (e.g. SDS-PAGE, western blots IEF, ELISA, activity/potency assays, protein concentration assays, HPLC and other assays).
5. The development and manufacturing of Bio-Conjugation and protein modification processes.
6. The implementation and transfer to production of processes (new and existing) defined during development.
7. Develop, plan and execute pre-GMP scaled process runs, establish Bill Of Materials list for process.
8. The writing and execution of design input protocols and design output reports.
9. The writing of SOPs and batch records for newly implemented manufacturing processes.
10. Communicate and coordinate activities with other project team members to ensure the smooth transition and efficient transfer of project to manufacturing.
11. Implementation of new technologies as appropriate or as needed.
12. Assurance of process compliance with cGMPs and/or ICH guidelines as appropriate.
13. Assurance of process compliance with and completion of all deliverables contained within the SOWs.
14. Maintain laboratory inventories and equipment.
15. Oversee and Train Process Development Associate Scientists as needed.
16. Communicate the project status with clients and Project Management as needed.
17. Manage Laboratory schedules to account for priority changes and project status.
18. Multi-task multiple projects.
19. Estimate Technical aspects of processes for Sales and marketing.

Position Requirements:
Education: BS, MS, or PhD, in chemical, biological or biochemical sciences.

Experience: BS 6+ years (or MS with 4+ years or Ph.D with 2+ years) of relevant process development and manufacturing experience in the Biotech industry with proven track record of accomplishments in the areas of protein purification, bio-conjugation and protein characterization). Experience with monoclonal antibody process development, manufacturing and characterization is a plus.

Skills: Must be able to work semi-independently with minimum direction. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Good communication and computer skills. Experience with process/product validation is a plus.

Scope of Function:
1) Assist in the transfer of existing upstream mammalian cell culture processes into upstream process development, analyzing ongoing processes, and resolving technical issues.
2) Assist in the development and scale-up of new mammalian cell culture processes.

Specific Duties:
1) Assist in all upstream development activities including; cell culture, cell banking, media optimization, seed train design, feed strategy, bioreactor parameter optimization, harvest clarification, and transfer to manufacturing.
2) Maintain laboratory inventory and equipment.
3) Record process development activities and results in appropriate notebooks and spreadsheets.
4) Assist with writing SOPs, batch records, and experimental plans and reports.
5) Multi-task multiple projects as necessary.

Position Requirements:
Education: BS, MS in biological or biochemical sciences.
Experience: 2-3 years relevant laboratory experience.

Skills:
1) Must be able to work semi-independently with minimum direction.
2) Must be able to execute experimental protocols as they pertain to the duties listed above.
3) Must have excellent aseptic technique, cell culture experience, communication skills, and computer skills.
4) Familiarity with basic cell culture lab equipment.

Optional Skills: Experience with small scale (1 – 10 L) bioreactors, suspension cell culture, SDS-PAGE / Western Blot, and ELISA.