Title  Manager Downstream Processing Operations

Department  Downstream Processing Operations

Category  Manufacturing/Operations

Type  Regular Full-time

Job Description This management position is responsible for managing the Downstream Processing staff. Responsible for assuring manufactured products meet high purity product specifications and scheduled completion dates. Duties include carrying out and supervising complex manufacturing operations to purify and modify antibodies and other proteins.

• Clarification of Bioreactor Harvest
• Diafiltration and Ultrafiltration
• Purification of Proteins and Antibodies by Chromatography
• Conjugation of Monoclonal Antibodies to Reporter Molecules
• In Process Bio-analytical Assays
• Formulation and Final Fill Finish

Requirements  Bachelor’s/ Masters/Ph.D degree in science with extensive GMP/QSR protein and antibody manufacturing experience. Knowledge of analytical methodologies, inventory control, and validation experience desired.  Candidate must possess excellent written and oral communication skills, and the ability to creatively solve complex problems. Candidate must be detail oriented, self-motivated and work well within a team environment.

Minimum Experience  5 years

Required Education  BS/MS/Ph.D Biology, Biochemistry, or Related Scientific Degree

Title  Biologist

Department  Upstream Processing Operations

Category  Manufacturing/Operations

Type  Regular Full-time

Job Description  This position is responsible for carrying out complex manufacturing operations in a cleanroom environment. Responsibilities include:

• Preparation of Master and Working Cell Banks
• Expansion of Seed Cultures For Bioreactor Inoculations
• In vitro Monoclonal Antibody Production

Responsibilities also include assisting senior scientific staff by performing techniques associated with monoclonal antibody development and transfection of mammalian cell lines. 

Requirements  A bachelor’s degree in science with relevant GMP/QSR manufacturing experience, including  mammalian cell culture of CHO,  HEK 293 and hybridoma cell lines is required. Knowledge of analytical methodologies, inventory control, and validation experience desired. Candidate must possess excellent written and oral communication skills, and the ability to creatively solve complex problems.  Candidate must be detail oriented, self-motivated and work well within a team environment.

Minimum Experience  2 years

Required Education  BS/MS  Biology, Biochemistry, or Related Scientific Degree

Title  Biologist

Department  Downstream Processing Operations

Category  Manufacturing/Operations

Type  Regular Full-time

Job Description This position is responsible for carrying out complex manufacturing operations to purify and modify antibodies and other proteins.

• Clarification of Bioreactor Harvest
• Diafiltration and Ultrafiltration
• Purification by Chromatography
• Conjugation of Monoclonal Antibodies to Reporter Molecules
• In Process Bio-analytical Assays
• Formulation and Final Fill Finish

Requirements  Bachelor’s or Masters degree in science with relevant GMP/QSR manufacturing experience. Knowledge of analytical methodologies, inventory control, and validation experience desired.  Candidate must possess excellent written and oral communication skills, and the ability to creatively solve complex problems. Candidate must be detail oriented, self-motivated and work well within a team environment.

Minimum Experience  2 years

Required Education  BS/MS Biology, Biochemistry, or Related Scientific Degree

Title  Biologist

Department  Upstream Processing Operations

Category  Manufacturing/Operations

Type  Regular Full-time

Job Description  This position is responsible for carrying out complex manufacturing operations such as large scale production of monoclonal antibodies and recombinant proteins in stirred tank and hollow fiber bioreactors.  Responsibilities include:

• Assembly and Sterilization of Bioreactors
• Mammalian Cell Culture in Stirred Tank and Hollow Fiber Bioreactors
• Perform Routine Metabolic Assays to Monitoring Bioreactors
• Write SOP’s and Bath Records
• Process Bioreactor Harvest

Requirements  A Bachelor’s degree in science with relevant GMP/QSR manufacturing experience, including  mammalian cell culture of CHO,  HEK 293 and hybridoma cell lines in bioreactors is required. Knowledge of analytical methodologies, inventory control, and validation experience desired. Candidate must possess excellent written and oral communication skills, and the ability to creatively solve complex problems. Candidate must be detail oriented, self-motivated and work well within a team environment.

Minimum Experience  2 years

Required Education  BS/MS  Biology, Biochemistry, or Related Scientific Degree

Title   Sr. Biologist

Department  Upstream Processing Operations

Category  Manufacturing/Operations

Type  Regular Full-time

Job Description  This is a dual role position which includes taking a lead scientific role in upstream manufacturing and development of innovative bioprocess systems. You will carryout complex manufacturing operations such as preparation of master and working cell banks, expansion of seed cultures for bioreactor inoculation and small scale In vitro monoclonal antibody production.  Research responsibilities will include monoclonal and hybridoma cell line development, mammalian cell culture feeding strategies and development of novel transgene expression technologies for production of recombinant proteins and monoclonal antibodies.

Requirements  Relevant GMP/QSR manufacturing experience including monoclonal antibody and hybridoma cell line development, mammalian cell culture of CHO,  HEK 293 and hybridoma cells as well as production of recombinant proteins and antibodies is required. Knowledge of analytical methodologies, inventory control, and validation experience desired. Candidate must possess excellent written and oral communication skills, and the ability to creatively solve complex problems. Candidate must be detail oriented, self-motivated and work well within a team environment.

Minimum Experience  4 years

Required Education  MS/Ph.D  Biology, Biochemistry, or Related Scientific Degree

Title  Quality Assurance and Document Control Manager

Department  Quality Assurance

Category  Quality

Type  Regular Full-time

Job Description  This position is responsible for quality assurance and technical services. Responsibilities include:

• Writing SOP’s and Batch Records
• Document Control
• Master Manufacturing Files
• Technical Writing
• Management of ISO9001:2000 Quality System
• Answering Customer’s Technical Product Questions

Requirements A bachelor’s degree in science with relevant quality systems/cGMP experience in an IVD manufacturing environment. Candidate must possess excellent written and oral communication skills and the ability to creatively solve complex problems. Candidate must be detail oriented, self-motivated and work well within a team environment.

Minimum Experience  4 years

Required Education  BS/MS  Biology, Biochemistry, or Related Scientific Degree