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Wugen, Inc. is a clinical-stage biotechnology company with research facilities in San Diego, CA and St. Louis, MO. We develop novel allogeneic “off-the-shelf” NK and CAR-T cell therapies for the treatment of solid tumors and hematologic malignancies.  Come join us in our pursuit to innovate and cure cancer.

Wugen is an equal opportunity employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

Open Positions

Senior Director/Vice President – Regulatory Affairs

Location: San Diego, CA; or remote work eligible

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our teams in San Diego and St. Louis. This candidate will provide regulatory leadership in support of all development programs at Wugen. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This candidate represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the Regulatory Affairs Department.

Primary Responsibilities

  • Lead the Regulatory Affairs function, including managing a small team.
  • Develop and implement regulatory strategies for all company development programs.
  • Manage the preparation and timely submission of documents to regulatory authorities (FDA, EMA and other national authorities), including INDs, CTAs, briefing documents for key meetings, responses to regulatory requests and BLAs.
  • Serve as the primary point of contact for regulatory authority interactions, including the preparation and regulatory leadership for key meetings including Pre-IND, etc.
  • Ensure that the content and format of regulatory submissions and amendments are in compliance with all applicable regulations and guidelines for cell and gene therapy products.
  • Serve as the internal primary conduit on all Regulatory matters for senior leadership.
  • Serve as the subject matter expert on US, EU, ICH and other applicable regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide overall product and clinical development plans.
  • Develop risk assessment scenarios and review mitigations and contingencies plans with multidisciplinary team.
  • Collaborate with third party consultants and CROs to supplement expertise and operational capacity.
  • Remain knowledgeable of current regulations and guidance, provide thoughtful interpretation of same and notify appropriate personnel.
  • Develop, review and maintain Regulatory and other applicable SOPs and policies.
  • Lead effective management of the Regulatory Affairs function, including budget administration, cost control, etc.

Preferred Qualifications

  • Bachelor’s degree in biology or related field. Advanced degree, such as MS, PhD, PharmD preferred.
  • 10+ years of direct experience in Regulatory Affairs in Biotech/Pharma for drugs and biologics. RAC certification desired.
  • Must have some regulatory experience with biologic programs in oncology drug development. Cell/gene therapy experience is preferred.
  • Experience developing and leading global regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track record of successful approvals; knowledge of expedited programs like Breakthrough Therapy, PRIME, Orphan Drug Designation is desired.
  • Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
  • Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, deficiency letter and regulatory responses.
  • Previous experience leading and managing a Regulatory team desired.
  • Strong interpersonal skills with the ability to negotiate and influence others in a positive and effective manner.
  • Capacity to react quickly and decisively in unexpected and dynamic situations.
  • Ability to lead, provide direction and guidance, make decisions, think critically, solve problems and respond proactively.
  • Must have excellent communication skills (both written and oral).
  • Strong project management skills required.

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Sr. Manager / Associate Director: Outsourcing

Location: Saint Louis, MO, San Diego, CA; or remote

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing CMC team to be based in St. Louis, MO or San Diego, CA. This candidate will be responsible for maintaining the interface with Wugen contract service providers as well as interacting with internal and external parties to provide Project Managment support.

Primary Responsibilities:

Contract Service Provider (CSP) Oversight

  • Be the business Single Point of Contact for key suppliers/providers
  • Help draft/approve SOP for CSP Oversight
  • Perform assessments of CSPs (retrospectively & prospectively)
  • Define metrics and actively monitor CSP performance
  • Write/monitor/manage: Request for Proposals, Requests for Information, Master Service Agreements, Quality Assurance Agreements, Scope of Work, Change Orders, Purchase Orders, and Invoices, as needed

Project Management

  • Support teams by developing and tracking adherence to schedules (Process Development, CSPs, prep of filings, etc.)

Quality Assurance Interface

  • Work w/QA to develop risk-based approach to evaluating vendors, materials, deviations, etc. – using structured tools (e.g. 6σ, Lean)
  • Facilitate investigations, as needed, providing guidance/tools.

Regulatory Filings

  • Support the vendor-specific sections of filing documents (describing manufacturing facilities, management of donors, storage, etc.)

Required Qualifications:

  • Degree in engineering, biology, or related technical field. 10+ years experience with a BS, 8+ years with an MS; 6+ years with a PhD; industry experience required.
  • Project management experience in the pharmaceutical industry.
  • Outsourcing experience in the pharmaceutical industry.
  • Familiarity with Lean manufacturing and/or 6 Sigma principles
  • Statistical analysis proficiency for data analysis.
  • Self-motivated with ability to work with minimal direction and operate efficiently in a fast-paced, collaborative work environment.
  • Strong organizational and communication skills.
  • Working knowledge in standard software including Word, Excel, and PowerPoint.

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Regulatory Affairs Specialist

Location: San Diego, CA; or remote work eligible

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our teams in San Diego and St. Louis. This candidate will be responsible for providing regulatory support for clinical-stage projects. This includes providing regulatory guidance to cross-functional teams; supporting regulatory authority interactions, communications, and submissions; and reviewing project documentation to ensure compliance with applicable regulations and guidelines. The level of the position and compensation package will be competitive and commensurate with experience.

Primary Responsibilities

  • Support planning, preparation and review of regulatory submissions for INDs/CTAs, BLAs, meeting requests and briefing documents, including ammendments and annual reports to FDA, and other regulatory authorities.
  • Ensure that the content and format of regulatory submissions and amendments are in compliance with all applicable regulations and guidelines.
  • Review protocols, consent forms, R&D reports and scientific documents, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Develop and implement regulatory project time lines that align with corporate goals.
  • Provide strategic regulatory guidance to internal and external stakeholders.
  • Interface with CMC, R&D and clinical research teams and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities.
  • Coordinate with third party consultants and CROs to supplement expertise and operational capacity.
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.

Preferred Qualifications

  • Bachelor’s or advanced degree in science with 2+ years of experience in Regulatory Affairs within the biotech/pharmaceutical industry.
  • Direct experience and knowledge in preparation of INDs/CTAs and amendments.
  • Working knowledge of FDA/ICH GMP, GLP, and GCP regulations/guidelines, as well as understanding of the pharmaceutical product life cycle.
  • Detail oriented with strong organizational and communication skills.
  • Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced, collaborative work environment.
  • Strong knowledge in standard software including Word, Excel, and PowerPoint.

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Scientist Senior Scientist, CMC Quality

Location: St. Louis, MO or San Diego, CA; remote or work from home eligible

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing CMC team to be based in St. Louis, MO or San Diego, CA. This candidate will be responsible for helping to maintain Wugen Quality Systems as well as interacting with internal and external parties to provide Quality support.

Primary Responsibilities:

  • Champion the integration of core Quality Systems for Wugen including documentation, investigations, CAPA, training and change control.
  • Perform Quality Assurance review and approval of documents, records, specifications, and investigations.
  • Collaborate with functional teams to provide Quality guidance and assistance with controlled documents, training requirements and deviation resolution.
  • Provide routine Quality Systems support to Wugen teams including change control, management of records and data, and tracking of continuous improvement.
  • Apply critical thinking and problem-solving skills to identify potential compliance issues and escalate when appropriate.
  • Assist in the development of Quality Agreements and Quality metrics.

Qualifications:

  • BS/MS degree in science with 2+ years of work experience.
  • Experience working in the Pharmaceutical industry.
  • Applied knowledge of Quality/Compliance and GMP and GLP requirements.
  • Knowledge of biologics research, manufacturing and/or testing is preferred.
  • Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced, collaborative work environment.
  • Detail oriented with strong organizational and communication skills.
  • Strong knowledge in standard software including Word, Excel, and PowerPoint.

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Associate Scientist: Cell Therapy

Location: San Diego, CA

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing R&D team in San Diego. This candidate will be responsible for the execution of in vitro and in vivo preclinical studies and will play a vital role in the translation of our novel cell therapies to the clinic. The compensation package will be competitive and commensurate with experience and the specific level of the candidate.

Experience Required:

  • Experience in isolation and culture of primary immune cells, including T-cells and NK cells.
  • Background in immunology with a clear understanding of T or NK cell biology, and experience working with primary NK or T cells.
  • Hands on experience in in vitro cell based assays such as cytotoxicity, activation, proliferation and immune phenotyping.  
  • Knowledge in molecular biology, including transfection, transduction and gene editing techniques.
  • Prior experience with laboratory techniques such as multicolor flow cytometry, cytokine analysis techniques and cytotoxicity assays using Incucyte is preferred.
  • Some experience with immunology/immuno-oncology in vivo models is a plus. 
  • Strong oral and written communication skills

Qualifications:

  • BS degree in immunology, biology, pharmacology, or related scientific discipline with 3+ years of work experience.
  • MS degree with 1+ years of work experience
  • Self-motivated with ability to operate effectively within an entrepreneurial fast-paced work environment and to work independently and collaboratively to achieve program and company goals
  • A problem solver with strong ability to generate, interpret and present scientific data
  • Knowledge in standard software including Word, Excel, PowerPoint, and Prism

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Research Scientist/Senior Scientist: Cell Therapy

Location: San Diego, CA or Saint Louis MO

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing R&D teams in San Diego and St. Louis. This candidate will be responsible for the design and execution of in vitro and in vivo preclinical studies and will play a vital role in the translation of our novel cell therapies to the clinic. The level of the position and compensation package will be competitive and commensurate with experience and the specific level of the candidate.

Experience Required:

  • Experience in isolation and culture of primary immune cells, including T-cells and NK cells.
  • Strong background in immunology with in-depth understanding of tumor biology and T-cell and NK cell biology.
  • Hands on experience in in vitro cell based assays such as cytotoxicity, activation, proliferation and immune phenotyping.
  • Extensive knowledge in molecular biology, including transfection, transduction and gene editing techniques.
  • Prior experience with basic laboratory techniques such as multicolor flow cytometry, cytokine analysis techniques and cytotoxicity assays using Incucyte is preferred.
  • Experience with immunology/immuno-oncology in vivo models, including xenograft and syngeneic tumor models is strongly preferred. 
  • Strong oral and written communication skills
  • Ability to train, supervise and mentor junior scientists

Qualifications:

  • Ph.D. degree in immunology, biology, pharmacology, or related scientific discipline with 2+ years of work experience.
  • BS/MS degree with minimum 6+ years of work experience
  • A strong academic career with high impact publications in peer-reviewed journals
  • Self-motivated with ability to operate effectively within an entrepreneurial fast-paced work environment and to work independently and collaboratively to achieve program and company goals
  • A problem solver with strong ability to generate, interpret and present scientific data  
  • Strong knowledge in standard software including Word, Excel, PowerPoint.

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Associate Scientist, NK Cells

Location: St. Louis

Job Description

Wugen is seeking a cell biologist or immunologist to join its team which is rapidly developing novel and innovative engineered cell-based therapies for oncology. The initial focus for the successful candidate will be to test and optimize gene editing methods, culture engineered natural killer cells and further develop in vitro cell-based assays. This scientist will work closely with fellow synthetic biology scientists to evaluate the activity and efficacy of novel candidate cellular therapeutics.


The position level will be commensurate with the candidate’s qualifications and experience. Bachelor’s or master’s degree in a relevant discipline (cell biology or immunology preferred) is required as well as 1-3 years of relevant laboratory experience. Key expertise in one or more of the following areas is highly desired: mammalian cell culture, NK cells, gene editing, high-throughput screening, mouse efficacy models, viral vector transduction of lymphocytes, flow cytometry, cell-based assay design, RNA/DNA extraction, PCR-based assays, and cell purification methodologies. The successful candidate will possess strong laboratory skills, have excellent communication skills, attention to detail, demonstrate independent thinking, and be able to thrive in a collaborative and fast-paced team environment.

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Scientist/Engineer, CMC Technology Transfer

Location: St. Louis (or potentially remote)

Job Description

Join a fast-paced startup based in St. Louis with the opportunity to help drive process development activities of novel therapies for treating rare diseases.  The product development (PD) scientist/engineer role will focus on the transfer and implementation of Wugen-developed processes at contract manufacturing organizations (CMOs).  This role will also support in-house PD research and developing/running analytical methods.

Primary Responsibilities

  • Support manufacturing at an external CMO.
  • Work closely with research and development to ensure smooth transfer from discovery through development and into manufacturing/QC.
  • Support process development studies.
  • Support the development and running of analytical methods.
  • Write and/or review development protocols and reports.
  • Support IND activities, including reviewing, data verification, and potentially authoring sections.

Preferred Qualifications

  • Degree in engineering, biology, or related field. 5+ years experience with a BS, 3+ years with an MS, 1+ years with a PhD; industry experience strongly preferred.
  • Gene and cell therapy manufacturing, with GMP manufacturing or QC experience.
  • Technical transfer experience to a CMO and batch record creation/review.
  • Experience culturing T cells and NK cells.
  • Good sterile technique in a biosafety cabinet, hands on experience with the CliniMACS Prodigy system, and experience with formulation and cryopreservation with a controlled rate freezer.
  • Statistical analysis proficiency for data analysis.
  • Flow cytometry, qPCR, and cell-based assay experience considered a plus.

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Associate Scientist, CMC Analytical Development

Location: St. Louis

Job Description

Join a fast-paced startup based in St. Louis with the opportunity to help drive process development activities of novel therapies for treating rare diseases.  The associate scientist role is part of the CMC department, and will focus on executing experiments in flow cytometry.

Primary Responsibilities

  • Works under general supervision, to conduct and monitor laboratory experiments in molecular biology and/or flow cytometry utilizing established and published procedures.  
  • Assumes responsibility for the accuracy, quality, and timeliness of experimental results.  Analyzes and summarizes experimental results and reviews conclusions with supervisor. Consistently records results according to established formats.
  • May communicate results of experiments in the form of reports and presentations.
  • Performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA).
  • Contribute to daily laboratory operations such as ordering and stocking.  Formulate simple and complex reagents.  Use all equipment properly and perform maintenance if needed.

Preferred Qualifications

  • Degree in biology or related field. 3+ years’ experience with a BS, 1+ years with an MS.
  • Direct experience and basic understanding of fluorescent principles.
  • Experience with either nucleic acid amplification or flow cytometry.  Other immunostaining also considered.
  • Nucleic acid extraction or protein handling experience.   Experience handling clinical specimens a plus.
  • Ability to use aseptic technique successfully. Tissue culture experience desired.
  • Familiar with Microsoft Office suite of programs, especially Excel and programs used for data analysis.

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Associate Scientist, CMC Process Development

Location: St. Louis

Job Description

Join a fast-paced startup based in St. Louis with the opportunity to help drive process development activities of novel therapies for treating rare diseases.  The associate scientist role is part of the CMC department, and will focus on developing methods to culture and expand engineered T-cells and natural killer cells (NK cells). The successful candidate will possess a strong publication record, have excellent communication skills, attention to detail, demonstrate independent thinking and understand process development of cellular therapies.

Primary Responsibilities

  • Work under general supervision to conduct and monitor laboratory experiments utilizing established and published procedures.
  • Perform cell culture, flow cytometry and formulate reagents.  
  • Assume responsibility for the accuracy, quality, and timeliness of experimental results. Analyze and summarize experimental results and review conclusions with supervisor. Consistently record results according to established formats.
  • Communicate results of experiments in the form of reports and/or presentations.
  • Perform work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA).
  • Use all equipment properly and perform maintenance as needed.

Preferred Qualifications

  • Degree in biology or related field. 3+ years experience with a BS, 1+ years with an MS.
  • Experience culturing T cells and/or NK cells.
  • Good sterile technique in a biosafety cabinet.
  • Hands on experience with the CliniMACS Prodigy system and experience with formulation and cryopreservation with a controlled rate freezer a plus.
  • Flow cytometry, qPCR, and cell-based assay experience a plus.
  • Key expertise in one or more of the following areas is highly desired:  T-cell growth and differentiation, NK cell growth and differentiation, viral vector transduction of T-cells and NK cells, human lymphocyte cultures, mammalian cell process development, flow cytometry, gene-editing and cell purification methodologies. 

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Scientist, NK Cells

Location: St. Louis

Job Description

Wugen is seeking a cell biologist or Immunologist to join its team which is rapidly developing novel and innovative engineered cell-based therapies for oncology. The initial focus for the successful candidate is to further develop methods to culture and expand engineered natural killer cells. This incumbent will work closely with fellow synthetic biology scientists to evaluate the activity and efficacy of novel candidate cellular therapeutics.

The position level will be commensurate with the candidate’s qualifications and experience.

Key expertise in one or more of the following areas is highly desired:

NK cells, Gene editing, Cas9/CRISPR, shRNA, high-throughput screening, human lymphocyte culture, mouse efficacy models, RNA-Seq, viral vector transduction of lymphocytes, flow cytometry, and cell purification methodologies.

The successful candidate will possess a strong publication record, have excellent communication skills, attention to detail, demonstrate independent thinking, understand process development of cellular therapies, and be able to thrive in a collaborative and fast-paced team environment.

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