Job Description

BIOPHASE SOLUTIONS specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a BIOPHARMACEUTICAL ASSAY DEVELOPMENT MANAGER to work for an Orange County area CDMO.

RESPONSIBILITIES: 

• Perform and lead GMP testing of biopharmaceuticals
• Coordination and management of projects, resource allocation, lab and personnel management. 
• Act as a liaison with the Quality Assurance group, analyze and review data, prepare reports, anticipate bottlenecks, propose solutions, and participate in client communications.

QUALIFICATIONS:

• Education: Cell Biology, Biochemistry, Molecular Biology, or related discipline.
  • Bachelor's degree: 10 years relevant experience
  • Master's degree: 8+ years of experience
  • Doctorate Degree: 5+ years of experience
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Hands on experience with mammalian cell culture and the utilization of cell-based assays in GMP environment is a must. 
• 6+ years of industry experience with 2+ years (4 years preferred) in cGMP environment.
• 2+ years of direct supervisory experience with a successful track record of training and mentoring scientific staff
• Familiarity with two or more of the following: protein therapeutics, monoclonal antibodies, cytokines, nucleic acid therapeutics, gene therapy, immunology, oncology, virology. 
• Experience in method development/transfer/validation and lot release tests
• Familiarity with statistical methods and compliant software (e.g. JMP, SoftMax Pro, PLA, StatLIA) is a plus.
• Excellent planning and follow through skills required. 
• Ability to work effectively under pressure to meet deadlines and CRO/CDMO experience preferred.

Please send resumes to gavin@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!