JOB SUMMARY:
Provide hands-on direction for all manufacturing activities. Director will have full responsibility for manufacturing division and compliance with BLA requirements.

ESSENTIAL FUNCTIONS:
1. Works under cGMP FDA regulations in the production of recombinant proteins for commercial human use.
2. Implements production of all products
3. Integrates engineering projects into the regular operating process.
4. Works with the Chief Financial Officer to develop operating budgets.
5. Monitors all production reports to ensure achievement of financial, safety, quality, and on-time delivery goals.
6. Organizes the management talent base for efficient operations; promotes opportunities for management to upgrade skills through training sessions and seminars.
7. Coordinates and monitors plans for reductions in cost and product lead times for existing and new products.
8. Directs the implementation of advanced technology to aid in reaching production goals.
9. Oversees the programs instituted by the environmental, health, and safety director to ensure a healthful and safe working environment and to comply with federal and state regulations in regard to the same.
10. Follows the quality management system instituted by the Director of Quality Assurance, and is able to train production personnel on proper equipment function.
11. Directs major facilities development.
12. Reports to the Chief Operating Officer on a regular basis. Works closely with that officer and the director of engineering to establish long-range operating goals and expansion.
13. Maintain a state of compliance within the manufacturing facility.

QUALIFICATIONS AND REQUIREMENTS:
1. Bachelor's degree required; master’s degree preferred.
2. Ten years of hands-on experience with upstream fermentation and downstream purification with bacteria and mammalian recombinant protein manufacturing.
3. Excellent verbal and written skills.
4. Excellent organizational skills.
5. Experience with FDA audits and participation in BLA fillings.
6. Ability to motivate team efforts to accomplish goals.

APPLY NOW

JOB SUMMARY:
Provide hands-on direction for Fermentation and Cell Culture process Development, process optimization, transfer and cGMP manufacturing activities. This position requires extensive technical expertise in E-coli and mammalian cell based cell culture systems, cGMP manufacturing and compliance for BLA requirements.

ESSENTIAL FUNCTIONS:
1. Upstream process development, optimization, characterization, scale-up, technology/process transfer for cGMP manufacturing, process troubleshooting and data analysis.
2. Works under cGMP FDA regulations in the production of recombinant proteins for commercial human use.
3. Provide technical direction in developing culture process.
4. Supervise in the execution of small-scale validation studies.
5. Monitors all production reports to ensure achievement of financial, safety, quality, and on-time delivery goals.
6. Organizes the management talent base for efficient operations; promotes opportunities for management to upgrade skills through training sessions and seminars.
7. Coordinates and monitors plans for reductions in cost and product lead times for existing and new products.
8. Directs the implementation of advanced technology to aid in reaching production goals.
9. Oversees the programs instituted by the environmental, health, and safety director to ensure a healthful and safe working environment and to comply with federal and state regulations in regard to the same.
10. Follows the quality management system instituted by the Director of Quality Assurance, and is able to train production personnel on proper equipment function.
11. Maintain a state of compliance within the manufacturing facility.

QUALIFICATIONS AND REQUIREMENTS:
1. BS, MS, or PhD, in chemical, biological or biochemical sciences.
2. BS 6+ years (or MS with 4+ years or Ph.D with 2+ years) of relevant process Demonstrated skill in microbial fermentation/mammalian cell culture techniques.
3. Demonstrated skill in the operation and analysis of bioreactor/fermentor systems at various scales.
4. Experience in cGMP and large scale manufacturing equipments and practices and with the transfer of technology to cGMP operations.
5. Excellent verbal, written and organizational skills.
6. Experience with FDA audits and participation in BLA fillings.
7. Ability to motivate team efforts to accomplish goals.

APPLY NOW

JOB SUMMARY:
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.

ESSENTIAL FUNCTIONS:
1. Develop and perform in-process assays for protein as required such as ELISA, SDS- PAGE, IEF, HPLC, WESTERN BLOT, CZE, and other pertinent biological and biochemical assays as they pertain to GMP standards.
2. Responsible for clean rooms environmental monitoring and purified water testing according to cGMP guideline.
3. Record development and qualification activities and results in appropriate notebooks.
4. Write and execute qualification protocols and reports for newly developed assays.
5. Write SOPs and train Quality Control group on newly developed assay processes.
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. Maintain laboratory inventories and equipment.
9. Keep abreast with new technologies and products that may aid in the assay development process.
10. Monitors all production reports to ensure achievement of financial, safety, quality, and on-time delivery goals.
11. Organizes the management talent base for efficient operations; promotes opportunities for management to upgrade skills through training sessions and seminars.
12. Oversees the programs instituted by the environmental, health, and safety director to ensure a healthful and safe working environment and to comply with federal and state regulations in regard to the same.
13. Follows the quality management system instituted by the Director of Quality Assurance, and is able to train production personnel on proper equipment function.
14. Test raw material, in-process, and final products in support of manufacturing.

QUALIFICATIONS AND REQUIREMENTS:
1. BS, MS, or PhD, in chemical, biological or biochemical sciences.
2. 5 to 10 years relevant laboratory experience in assay development and protein characterization, particularly in the areas of immunology.
3. Familiar with assays such as N-terminal amino acid analysis and peptide mapping, carbohydrate analysis and potency assay
4. Ability to understand and explain the methodology of the analytical tests as well as perform the activity.
5. Experience in assay qualification and validation is a plus.
6. Excellent verbal, written and organizational skills.
7. Experience with FDA audits and participation in BLA fillings.
8. Ability to motivate team efforts to accomplish goals.

APPLY NOW

JOB SUMMARY:
Downstream Process Development for recombinant therapeutic protein manufacturing using mammalian/microbial expression systems, process optimization, technology/process transfer and perform cGMP manufacturing.

ESSENTIAL FUNCTIONS:
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 process.
2. The development of filtration processes including Sterile Filtration, Ultrafiltration, Diafiltration, Microfiltration, and viral (Nano) Filtration.
3. May set up experimental procedures of moderate complexity with limited instruction.
4. According to established procedures, records results in a clear and concise manner in production batch records and / or laboratory notebooks
5. Works under cGMP FDA regulations in the production of recombinant proteins for commercial human use.
6. Maintain a state of compliance within the manufacturing facility.
7. Ensure proper stock of supplies for all labs.
8. Write and/or review SOPs and Specifications as required to comply with cGMP practices.
9. Write, execute, or assist in any Validation or Calibration projects related to the Downstream Operations equipment
10. Maintain cGLP notebook for all non-GMP projects

QUALIFICATIONS AND REQUIREMENTS:
1. BS, MS in biological or biochemical sciences with 2-5 years relevant experience.
2. Experience in cGMP and large scale manufacturing equipments and practices and with the transfer of technology to cGMP operations.
3. Familiarity with protein refolding, TFF and AKTA Process system
4. Excellent verbal, written and organizational skills.

APPLY NOW

JOB SUMMARY:
Responsible for development and qualification of relevant biochemical and biological assays. Test raw material, in-process, and final products in support of manufacturing. Routine water sample testing.

ESSENTIAL FUNCTIONS:
1. Develop and perform in-process assays for protein as required such as ELISA, SDS- PAGE, IEF, HPLC, WESTERN BLOT, CZE, and other pertinent biological and biochemical assays as they pertain to GMP standards.
2. Responsible for purified water testing according to cGMP guideline.
3. Record development and qualification activities and results in appropriate notebooks.
4. Write and execute qualification protocols and reports for newly developed assays.
5. Write SOPs and train Quality Control group on newly developed assay processes.
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. Maintain laboratory inventories and equipment.
9. Monitors all production reports to ensure achievement of financial, safety, quality, and on-time delivery goals.
10. Follows the quality management system instituted by the Director of Quality Assurance, and is able to train production personnel on proper equipment function.
11. Test raw material, in-process, and final products in support of manufacturing.

QUALIFICATIONS AND REQUIREMENTS:
1. BS or MS in chemical, biological or biochemical sciences.
2. Relevant laboratory experience in assay development and protein characterization, particularly in the areas of immunology.
3. Ability to understand and explain the methodology of the analytical tests as well as perform the activity.
4. Experience in assay qualification and validation is a plus.
5. Excellent verbal, written and organizational skills.

APPLY NOW

JOB SUMMARY:
Upstream Process Development for recombinant therapeutic protein manufacturing using mammalian/microbial expression systems, process optimization, technology/process transfer and perform cGMP manufacturing.

ESSENTIAL FUNCTIONS:
1. Upstream process development, optimization, characterization, scale-up, technology/process transfer for cGMP manufacturing, process troubleshooting and data analysis.
2. May set up experimental procedures of moderate complexity with limited instruction.
3. According to established procedures, records results in a clear and concise manner in production batch records and / or laboratory notebooks
4. Works under cGMP FDA regulations in the production of recombinant proteins for commercial human use.
5. Maintain a state of compliance within the manufacturing facility.
6. Ensure proper stock of supplies for all labs.
7. Write and/or review SOPs and Specifications as required to comply with cGMP practices.
8. Write, execute, or assist in any Validation or Calibration projects related to the Upstream Operations equipment
9. Maintain cGLP notebook for all non-GMP projects

QUALIFICATIONS AND REQUIREMENTS:
1. BS, MS in biological or biochemical sciences with 2-5 years relevant experience.
2. Must have excellent aseptic technique, cell culture experience, communication skills, and computer skills.
3. Familiarity with basic cell culture lab equipment. Experience in cGMP and large scale manufacturing equipments and practices and with the transfer of technology to cGMP operations.
4. Excellent verbal, written and organizational skills.
5. Due to the nature of cell culture and fermentation work periodic weekend as well as off-hours work will be expected.

APPLY NOW

JOB SUMMARY:
Sanitization of floors, walls and ceilings in clean rooms and lab areas. Stocking of bins in clean rooms which would contain clean room gowns, gloves, bonnets shoe covers and miscellaneous other supplies. Removal of soiled materials from the facility, washing dishes from lab areas and assisting Facility with any other maintenance or calibration items that may be required.

ESSENTIAL FUNCTIONS:
1. Must be neat and orderly.
2. Will need to work under cGMP FDA regulations
3. Follow written and verbal directions.

QUALIFICATIONS AND REQUIREMENTS:
1. A High School Diploma or equivalent.
2. Must be able to communicate in English.

APPLY NOW

JOB SUMMARY:
The administrative assistant assists the Company with day-to-day operations. The administrative assistant also serves as the first point of contact for visitors to the Company, and, as such, ensures that a positive impression is left with visitors, whether in person, by e-mail, or on the phone. The administrative assistant ensures that tasks are taken care of consistently and dependably. This position requires quick thinking, the ability to multitask, and utmost professionalism.

ESSENTIAL FUNCTIONS:
1. Write up and send correspondence.
2. Assist with filings with the US Patent and Trademark Office.
3. Assist with making travel arrangements.
4. Assist with hotel arrangements for traveling employees and visitors.
5. Assist with transportation arrangements for traveling employees and visitors.
6. Assist with keeping track of payments and receipts for properties.
7. Answer and route phone calls, and take messages.
8. Assist with food and drink arrangements for visitors.
9. Keep track of breakroom supplies and inform purchasing department when items need to be reordered.
10. Assist with scanning and filing documents.
11. Other responsibilities as determined by management.

QUALIFICATIONS AND REQUIREMENTS:
1. Successful candidate will possess at a minimum a bachelor’s degree and/or relevant experience.
2. Proficiency with software such as Microsoft Office (especially Word, Excel, and PowerPoint) and Adobe Acrobat.
3. Excellent verbal, written, and organizational skills.
4. Have strong attention to detail.
5. Must be neat, orderly, and professional in appearance and behavior.
6. Be fluent in reading, writing, speaking, and understanding English.

APPLY NOW