GenVivo
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CAREERS

Working at GenVivo

  

To be considered as an applicant, please submit your CV referencing the specific position of interest to careers@genvivoinc.com.  Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. 


Genvivo, Inc. offers competitive compensation & benefits package:

We are committed to our employees and their families. Our philosophy is to offer a comprehensive compensation and benefits package to support our greatest assets, our employees. This package includes a competitive base salary and the following benefits:

· 401(k)

· Health, Dental & Vision Insurance

· Life and AD&D Insurance 

· Flexible Spending Accounts

· Employee Assistance Program (EAP)

· Paid Time Off (Vacation, Sick and Personal Days)

· Paid Holidays

· Employee Discount Program membership through Ticketsatwork.com.


The compensation and benefits package may also include new hire stock options and ongoing incentive stock options. 


GenVivo, Inc.  reserves the right to modify or terminate the above benefits at any time with or without notice.


 Equal Employment Opportunity Employer
As an equal opportunity employer, GenVivo, Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. It is also GenVivo’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster. 


Current Openings

We currently have the following opening(s):


  • GMP Manufacturing Lead/Associate - Downstream
  • Post-Doctoral Associate
  • Quality Control Manager
  • Assay Development Principal Scientist I
  • Administrative Assistant


To apply please email  CV to careers@genvivoinc.com

OPEN POSITIONS

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GMP Manufacturing Lead/Associate - Downstream

  General Job Description:

  As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, development and manufacturing, the successful candidate will be part of a skilled GMP Manufacturing team working to execute GMP production runs to supply the company’s clinical pipeline. Other responsibilities include meeting with vendors to negotiate and procure equipment, leading and supporting IQ/OQ activities for facility and process equipment, creating SOPs and Batch records, establishing operational policies and procedures, writing and assisting in deviation report closures, and other activities to ensure a successful production campaign. 


Primary Duties and Responsibilities include but are not limited to:

• Execute bioprocess operations successfully in Purification; strong/proven experience in both manual and automated chromatography operations, UF/DF operations, and bulk filtration

• Perform aseptic operations in the BSC/LFH with good aseptic technique

• Perform CIP/ SIP operations: Cleaning, assembly, sterilization, disassembly, and operation of primary process equipment

• Transfer process from lab-scale to GMP-scale in support of creating material for early stage clinical studies

• Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency

• Effectively engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing

• Inventory management

• Generate, review and/or revise GenVivo batch production records, logbooks, and SOP’s to support manufacturing operations

• Ensure that SOP’s and batch records are accurate, and followed in accordance with cGMP regulatory expectations

• Support and execute media and buffer preparation

• Successfully report and troubleshoot processing and equipment issues

• Maintain and sustain all organizational training profile requirements

• Comply with all GenVivo safety requirements, cGMP, GenVivo SOP’s and manufacturing documentation

• Maintain appropriate interpersonal relationships with all members of management, company employees, service providers, technical support staff and all others associated with, relating to or doing business with the company.


Required Qualifications:

The ideal candidate must have:

· Bachelor of Science degree or higher

· Minimum of 2 years of experience in cGMP operations (working with manufacturing equipment preferred)

· High degree of self-motivation and initiative

· Ability to work under pressure and against tight timelines 

· Ability to work as part of a team and work independently with supervision 

· Strong commitment to working safely 

· Ability and willingness to work flexible hours when necessary (off-shift and long hours as required)

· Excellent written and verbal communication skills

· Mechanical aptitude, and working knowledge of computer systems

· Ability to lift 30 lbs 

· Ensures project deadlines and performance standards are met

· Professional integrity and maturity with high degree of discretion dealing with confidential information

· Eligibility to work in the U.S.


 Apply to: GenVivo, Inc. - Attn: HR - careers@genvivoinc.com

careers@genvivoinc.com

Post-Doctoral Associate

  

General Job Description:

This position is located within the Research & Development department to support projects involving retrovector-based products for cancer immunotherapy. The successful candidate will be in a fast-paced, collaborative and interdisciplinary environment dedicated to meeting research and manufacturing milestones in service to the patients enrolled in our clinical trials. This position is mainly focused on the study of retrovector targeting. The individual will be responsible for performing under general direction, complex experiments and other research activities. The core technical skills for the position include: molecular biology techniques, cell function assays, cell culture, immunological techniques and others as needed. The successful candidate will integrate advice and feedback from team members and management with their own expertise in developing additional contributions above and beyond these core requirements. This position offers a unique opportunity to join in the continuing rapid growth of a Phase I clinical development company.


Primary Duties and Responsibilities include but are not limited to:

· Perform complex experiments independently with accuracy and focus within a time frame;

· Provide technical support and assistance to team members when needed;

· Report and discuss findings with supervisors;

· Document all experimental procedures, conditions, observations, data and results in detail in either a lab notebook or quality control document;

· Produce scientific representations of the data for documentation and for scientific presentations;

· General lab management including but not limited to equipment functions, receiving and distribution of supplies;

· Perform other duties as assigned.


Required Qualifications:

The ideal candidate must have:

· Recent PhD graduate in relevant scientific field;

· Extreme attention to detail and diligent in experimental design, data analysis and review;

· Strong analytical and problem solving skills;

· Excellent interpersonal, written and verbal communication skills;

· High level of motivation and initiative;

· Comfortable in a dynamic, high energy, fast-paced team environment; 

· Demostrate 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;

· Knowledge  and performance of biosafety guidelines and procedures;

· Computer skills (Microsoft Office: Word, Excel, PowerPoint, various equipment software, and others as applicable);

· Ability and willingness to work flexible hours when necessary;

· Eligibility to work in the U.S.


Desirable Qualifications:

· Strong background in Virology, Biochemistry, and Cell Biology;

· Experience with enveloped viruses;

· Deep and practical knowledge in viral envelope structure/function; molecular biology; bioengineering is a plus;

· Experience in protein expression systems;

· Experience in protein targeting;

· Experience with laboratory management; 

· Research lab experience with good documentation practices and Good Laboratory Practices (GLP), Standard Operating Procedures (SOP) and independent experimentation in method development and validation.


  Apply to: GenVivo, Inc. - Attn: HR - careers@genvivoinc.com.  

CAREERS@GENVIVOINC.COM

Quality Control Manager

 

General Job Description:

As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, development and manufacturing, the successful candidate will lead all areas of Quality Control providing support to the GMP Manufacturing team and Process Development and our clinical programs. The key deliverables are the implementation of a raw materials program, in-process and final product testing, stability testing for DS and DP, assay development and assay qualification, clinical research assays, environmental monitoring, and authoring of SOPs and STM’s. Other responsibilities include supporting IQ/OQ activities for QC equipment, establishing operational policies and procedures, and many other activities to ensure a successful QC Analytical and QC Micro labs.


Primary Duties and Responsibilities include but are not limited to:

  • Implement and maintain raw material program activities such as sampling, testing, and releasing
  • Review, approve, and trend QC test data associated to clinical research samples, in-process, final product and stability testing
  • Work as part of a small team to execute QC test method qualifications and method transfer in close collaboration with the Assay Development team
  • Manage activities at Contract Testing Laboratories
  • Provide support in IQ/OQ activities and periodical calibration/PM activities for QC instruments and equipment
  • Assist in studies to support the validation and qualification of manufacturing areas
  • Lead and monitor the stability program for purified bulk and final product in accordance with ICH and FDA guidelines
  • Inventory and sample management
  • Initiation, evaluation, and closure of deviation and out-of-specification investigations and issue corrective actions
  • Author, review, and execute STMs and SOPs related to instruments and test methods
  • Disposition purified bulk and final product and prepare Certificate of Analysis as appropriate
  • Guide and lead all trouble shooting projects
  • Represent QC analytical and QC micro in all cross-functional activities
  • Train new QC operators
  • Assist in preparation of regulatory submission
  • Perform all activities in accordance with safety, cGMPs and company procedures
  • Perform other related duties and responsibilities as assigned

 

Required Qualifications:

The ideal candidate must have:

  • Bachelor’s degree or higher in Life Science, Chemistry, Biology, or other related discipline
  • 5+ years in quality control in cGMP operations preferably in a biotechnology or pharmaceutical industry
  • Knowledge of regulatory requirements and quality principles
  • High degree of self-motivation is required
  • Ability to work under pressure against tight timelines and prioritize work from multiple projects is required
  • Ability to provide specific training and education for internal and external project team members as needed
  • Capability to effectively articulate quality requirements and rationale
  • Ability to work as part of a team and work independently with minimal supervision
  • Excellent interpersonal skills and exhibit a professional manner in dealing with others
  • Strong commitment to working safely
  • Ability to work off-shift and long hours as required
  • Ability to lift 30 lbs is required
  • Proficiency to meet objectives of annual budgetary plan
  • Computer proficiency as well as ability to master new software programs
  • Skills to ensure project deadlines and performance standards are met
  • Ability to operate both independently and as a team member depending on current company priorities
  • Effective leadership skills and proven ability to foster team productivity
  • High degree of discretion dealing with confidential information
  • Eligibility to work in the U.S.

careers@genvivoinc.com

Assay Development Principal Scientist I

 

General Job Description:

This position will be responsible for assay development and assay optimization/qualification of molecular and cellular assays for preclinical studies, product release and stability testing, product characterization assays, as well as patient sample analysis. This position is expected to be responsible for new assay implementation, assay development, assay optimization to make QC ready methods. This position will be responsible for drafting assay development report, assay qualification protocol and report, as well as working with QC group to get the standard testing method through change control system. This position will be participating in deviation investigation and CAPA program as well.


Primary Duties and Responsibilities include but are not limited to:

  • Maintain cell lines and primary cells for cell-based assays
  • Assay Development and optimization on cell-based assays, flow cytometry, and RNA/DNA isolation and extraction efficiency optimization
  • New assay implementation for product characterization
  • Establish assay associated standard bank and perform qualification of the bank
  • Responsible for assay transfer into QC department and troubleshoot when needed
  • Responsible for training QC analyst on the new assays implemented
  • Will be involved in assay qualification and validation
  • Draft Assay Development report and assay qualification protocol and report
  • Draft Test Procedures and Standard Operating Procedures (SOP) for assays, quality control, and data management procedures.
  • May perform routine testing for immunological assays and ELISA
  • May perform routine testing for DNA/RNA quantification using RTPCR and ddPCR technique
  • Serve as subject matter expert or technical lead for investigation projects.



Required Qualifications:

The ideal candidate must have:

  • PhD in Biology, biochemistry or related discipline
  • Minimum 15 years hands-on proficiency cell culture techniques
  • Strong experience and knowledge on Molecular biology based analytical procedures
  • Strong assay development and assay optimization skills
  • Experience working in a GMP or GLP regulated environment
  • Ability to contribute and work in a cross-functional, multi-disciplinary team environment
  • Excellent organizational and problem-solving skills, and be able to plan and prioritize work plans appropriately
  • Strong attention to detail and familiarity with GMP documentation
  • Capability of effectively handling multiple projects simultaneously
  • Good understanding of drug development process
  • Good computer skills and working knowledge of common software
  • Possess critical thinking, initiation, management of success and failure of complex projects
  • Excellent verbal and written communication skills, including report writing skills
  • Strong interpersonal and communication skills, and be a team player
  • Proven initiative and demonstrated accountability to ensure project deadlines and performance standards are met
  • Professional integrity and maturity with high degree of discretion dealing with confidential information, while supporting the mission and strategic plan of the Company
  • Ability to operate both independently and as a team member depending on current company priorities
  • Ability and willingness to work flexible hours when necessary
  • Eligibility to work in the U.S.

careers@genvivoinc.com

Administrative Assistant

 

General Job Description:

This position is located within the Administrative/Finance department and is an excellent opportunity for a knowledgeable, experienced individual with exceptional interpersonal skills to thrive in a fast-paced environment. The department provides a collaborative and team oriented environment and provides administrative support to the entire organization.

The ideal candidate will have high degree of professionalism and discretion dealing with confidential information. The candidate will also be resourceful and provide general office administrative support throughout the organization. The ability to multi-task, problem-solve and maintain organization is essential. Assuring a steady completion of workload in a timely manner is key to success in this position.


Primary Duties and Responsibilities include but are not limited to:

  • Answer and direct incoming calls
  • Greet and assist visitors to the office
  • Process and distribute incoming mail
  • Maintain contact lists and manage multiple calendars in MS Outlook
  • Support management and other personnel with general office and administrative needs
  • Coordinate interviews and greet candidates
  • Organize and place company lunch orders for meetings and set up rooms as necessary
  • Maintain the office/breakroom supplies by checking inventory and order supplies as needed
  • Assist with formatting of documents in MS Word, Excel and PowerPoint
  • Assist with lab and manufacturing supply orders
  • Other duties and projects as assigned.


Required Qualifications:

The ideal candidate must have:

  • Bachelor's degree or equivalent
  • 3+ years’ experience in an administrative role, ideally within the pharmaceutical or biotech industries
  • Proficiency in MS Office with expertise in Microsoft Work, Excel, PowerPoint, and Visio
  • Excellent organizational and problem-solving skills with strong attention to detail
  • Capable of effectively handling multiple projects simultaneously
  • Excellent verbal and written communication skills, including report writing skills
  • Experience using purchasing/inventory management software a plus
  • Team player with strong interpersonal skills and proven ability to work effectively in a fast-paced team environment or independently depending on current company priorities
  • Proven initiative and demonstrated accountability
  • Professional integrity and maturity with high degree of discretion dealing with confidential information
  • Ability to support the mission and strategic plan of the Company and ensure project deadlines and performance standards are met
  • Ability and willingness to work flexible hours when necessary
  • Ability for occasional commute between San Marino and Pasadena sites
  • Eligibility to work in the U.S.

careers@genvivoinc.com