Downstream Purification Scientist

Location
91107, Pasadena
Posted
Jul 03, 2018
Ref
DPS 070318
Required Education
Masters Degree/MBA
Position Type
Full time

General Job Description:

The successful candidate will be responsible for the development of upstream processes for scalable production of viral vectors and gene delivery systems. The position will entail adaptation to scale of both established and novel viral vector production methods. In addition, the candidate will develop bioreactor technology for both attached mode and suspension cultures and utilize their experience to advance the project from bench scale to industrial-scale reactors in support of cGMP clinical viral vector production.  The position interfaces with a team of research scientists, regulatory specialists, and manufacturing operations management and will be instrumental in transferring the technology to an in-house pilot cGMP facility and eventually a contract manufacturing organization. Responsibilities will also include supporting Quality Assurance and Quality Compliance departments, scale-up functions in the research department, and support of IND-enabling studies.  Close interaction with members of the company team and adaptation to emerging needs are required. Finally, the position requires excellent written and verbal communication skills and the ability to work effectively in a dynamic team environment

Company Background:

GenVivo’s mission is to pioneer innovative gene therapies for administration to cancer patients in order to improve patient survival and ultimately to make patients cancer free. Our approach to synergistically kill tumors while activating the immune system to fight the patient’s cancer combined with the integration of novel companion diagnostics, positions us on the cutting edge of cancer immunotherapies and emerging clinical stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and since we are currently small, every individual and each idea is important and counts.

This is an excellent opportunity for a knowledgeable, experienced individual who can direct multiple initiatives and contribute to entrepreneurial thinking; someone who is results- and value-driven and believes in making a difference.

Primary Duties and Responsibilities (include but are not limited to):

  • Support and/or lead continuous improvement projects in the QC Micro Laboratory;
  • Environmental monitoring and/or Personal monitoring of clean rooms and controlled areas;
  • Participate in the generation of test plans, protocols, and reporting documentation monitoring the incubators, biosafety cabinets, etc.;
  • Perform microbial and particulate monitoring of clean rooms and controlled areas;
  • Testing to support microbial identifications, bioburden analysis, biological indicators, growth promotion, etc.;
  • Read microbial plates and interpret test results. Some troubleshooting will be required;
  • Perform change requests when required and complete them in a timely manner;
  • Ensure laboratory area is maintained in a GMP state at all times while following all EHS and GMP guidelines;
  • Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed;
  • Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner;
  • Will be crossed trained on Analytical testing methods and participate in release/stability testing as well as method qualification;
  • Ensure personal training requirements are met and that training records are current.​

Required Qualifications:

  • BS degree in Biology, Microbiology or related discipline with 3+ experience working in a Biotech or Pharmaceutical FDA regulated industry;
  • General knowledge of FDA regulations, applications of current Good Manufacturing Practices (cGMP);
  • Demonstrated ability to multi-task in a dynamic fast-paced cross-functional environment, with good quality and efficiency;
  • Team player with excellent written and interpersonal communication skills;
  • Able to work independently and with intermittent supervision;
  • Eligible to work in the U.S.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.

Primary Duties and Responsibilities (include but are not limited to):

  • Address scale-up needs focusing on a bioreactor approach using both adherent and suspension cells
  • Carry out vector manufacturing process development and optimization, and participate in the production of virus-based gene transfer vectors to support clinical studies
  • Help develop and optimize both research-grade and cGMP manufacturing methods establishing procedures for improving the yield and purity of bench top viral vector production while maintaining high standards of manufacturing operations in order to ensure that products conform to established company quality standards for research, pre-clinical studies, and/or clinical trials
  • Contribute to the writing of standard operating procedures (SOPs) and implementation of documentation to support cGMP vector manufacture including the technology transfer reports
  • Ensure that all of the technical, logistical and regulatory aspects of the manufacturing processes can be planned and addressed in a timely manner
  • Perform miscellaneous duties and projects as assigned and required

Required Qualifications:

  • Bachelor’s Degree or equivalent in the biological sciences with 2+ years biopharmaceutical / advanced therapies experience 
  • Knowledge of cGMP as applied to bioprocessing methodology and experience working in a pre-cGMP environment
  • Knowledge of standard cell culture techniques such as cell counting, cell biochemistry analysis
  • Prior practical experience of upstream process development; experience relevant to the production of viruses and proteins is especially valuable.
  • Combination of strong scientific and technological knowledge and skills relevant to our current and desired manufacturing methods, as implied by the above
  • The ability to learn new techniques and apply them to a high standard
  • Excellent interpersonal, verbal and written communication skills with attention to detail
  • Must possess a positive, can-do attitude and demonstrate creative, problem-solving skills
  • Ability to multi-task and work in a fast-paced, goal-oriented environment with flexibility to adjust to quickly changing priorities
  • Must demonstrate hands-on technical proficiency and independently conduct experiments and present work
  • Demonstrate ability to effectively and collaboratively work in cross-functional teams, meet deadlines, and prioritize multiple activities
  • Professional integrity and maturity with high degree of discretion dealing with confidential information
  • Ability and willingness to work flexible hours when necessary
  • Must be eligible to work in the U.S.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.