Chief Technology Officer/ Head of Technical Operations/ SVP, CMC

Opportunity

As a joint venture between MD Anderson Cancer Center and Berkeley Lights, Optera Therapeutics is a new clinical-stage biopharmaceutical company offering a unique and synergistic combination of biology and technology to develop best in class cell therapies for patients suffering from diseases with grave unmet needs.  Optera is currently developing two first-in-class, clinical-stage cell therapy programs and has exclusive rights to future cell therapy programs innovated at MD Anderson. 

Based in San Diego, CA, Optera is currently seeking an exceptional leader in CMC to join our leadership team.  Expanding on his/her previous successful track record in biologics manufacturing and quality assurance, the head of CMC will be responsible for leading and providing strategic direction, key decision making and oversight for registration-enabling process development, manufacturing operations, quality assurance and supply chain activities as well as commercial scale up and launch activities.

This is an exceptional opportunity to build, lead and develop a successful CMC function in a dynamic start-up company driven by a leadership team of proven drug developers.

Key Contributions/Responsibilities

  • Establish and execute overall CMC development, registrational and commercial strategy for Optera’s pipeline of four first-in-class cell therapy programs, including a lead program with clinical proof-of-concept in two high unmet need indications.

  • Provide strategic direction, tactical oversight and technical expertise for CMC functions, including Process Development, Analytical Development, Formulation Development, Contract Manufacturing, Supply Chain Management, and commercial scale-up.

  • Select, lead and manage Contract Manufacturing Organizations.

  • Serve as subject matter expert for all regulatory CMC submissions, including authoring (directly or via direct reports) of technical content.

  • Interface with FDA and other global regulatory agencies.

  • Collaborate with QA in the timely review of manufacturing documents, process deviations, and CMO audits.

  • Build out team/department in lean, cost-efficient manner, on an as needed basis.

  • Conduct analyses and provide recommendations as to when to insource vs. outsource strategic manufacturing.

  • Support team in diligence of additional assets and in licensing discussions with potential pharmaceutical partners.

 

Qualifications

  • Advanced degree in biology, chemistry, engineering or related scientific field.

  • Minimum of 12 years of pharmaceutical development /manufacturing experience with at least 4 years in Biologics.

  • Thorough knowledge of manufacturing techniques, process scale-up and commercial operations.

  • Experienced in the capabilities and management of outside consultants and contract organizations.

  • Skilled at preparing, negotiating and managing formal agreements and contracts with third parties, including supply agreements.

  • Proven ability to build out and lead multi-disciplinary teams.

  • Effective organizational traits with demonstrated project management and team facilitation skills.

  • Demonstrated capability in CMC regulatory affairs to support registrational strategy design, document preparation and FDA product approval.

  • Extensive knowledge of cGMPs, quality systems and industry standards.

  • Effective oral and written communication skills with strong interpersonal skills. Small company / pre-commercial stage company experience desirable.

 

Interested candidates, please submit resumes to jobs@opteratx.com

Vice President, Regulatory Affairs

Opportunity

As a joint venture between MD Anderson Cancer Center and Berkeley Lights, Optera Therapeutics is a new clinical-stage biopharmaceutical company offering a unique and synergistic combination of biology and technology to develop best in class cell therapies for patients suffering from diseases with grave unmet needs.  Optera is currently developing two first-in-class, clinical-stage cell therapy programs and has exclusive rights to future cell therapy programs innovated at MD Anderson.

Based in San Diego, CA, Optera is currently seeking an exceptional Regulatory leader to join our team.  Expanding on his/her previous successful track record in cell therapy, biologics and/or first-in-class programs developed for high unmet indications with no approved therapies or regulatory precedent, the VP, Regulatory will serve as global regulatory lead with responsibility for regulatory strategies and submissions for Optera’s Development Programs.

This is an exceptional opportunity to build, lead and develop a successful Regulatory function in a dynamic start-up company driven by a leadership team of proven drug developers.


Key Contributions/Responsibilities

  • Serve as global regulatory lead with responsibility for regulatory strategies and submissions

  • Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development.

  • Ensure high‑quality and timely regulatory submissions (IND and BLA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals.

  • Seek preferred regulatory designations such as RMAT/BTD, PRIME, Sakigake, as applicable.

  • Act as the primary liaison between Optera and regulatory authorities.

  • Build partnerships with cross-functional key stakeholders ensure that strategic business goals are met through the sharing of knowledge and expertise.

  • Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape.

  • Build out team/department in lean, cost-efficient manner, on an as needed basis.

  • Support team in diligence of additional assets and in licensing discussions with potential pharmaceutical partners.

 

 

 

Qualifications

  • A minimum of a Bachelor’s degree in life sciences, with an advanced technical degree of an MSc or PhD highly preferred, with at least 10 years industry experience.

  • Strong Regulatory experience both in clinical and CMC registration-enabling strategies.

  • Experience in cell therapy, biologics.

  • Experience in orphan disease and orphan drug applications.

  • Successful submission, approval, and post-approval management of a BLA  preferred.

  • Experience with preferred regulatory designations such as RMAT/BTD, PRIME, Sakigake highly desirable.

  • Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills.

  • Experience in building out a comprehensive regulatory affairs function.

  • Ability to think strategically while maintaining a hands-on tactical approach.

  • Willingness to drive product submissions, including document-writing in a lean, small company environment will be a critical success factor.

  

Interested candidates, please submit resumes to jobs@opteratx.com