Senior Manager, Cmc Project Management

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

 

GENERAL SUMMARY: 

4DMT is seeking a Sr. Manager, CMC Project Management, to join its Project Management team and ensure the progress and success of the clinical stage assets at 4DMT.

The ideal candidate will successfully leverage their prior CMC technical and drug development experience in complex biologics to partner with the chemistry manufacturing and controls/technical operations and the cross-functional teams to effectively drive the clinical development of 4DMT’s therapeutic assets in clinical development.

Experience and a deep understanding of the CMC development and GMP manufacturing requirements in all stages of drug development, from discovery to late-stage clinical development, is critical to the success of this role.

RESPONSIBILITIES:  

• Manage internal CMC project's scope, timelines, budget, risks, and documentation of meetings
• CDMO Project Management includes processing various legal documents and contracts needed to work with CDMOs.
• Identify project risks and proactively facilitate mitigation strategies and resolution.
• Ensure relevant communication and alignment across CMC departments as appropriate.
• In collaboration with Tech Ops leadership, create mid- and long-term project strategies and help determine the CMC needs of programs alongside CMC and similar colleagues.
• Responsible for ensuring flawless and smooth execution of CMC deliverables according to defined timelines and cost via leading multidisciplinary CMC teams as well as preparing accurate CMC updates for key stakeholders, including the Executive Team.
• Effectively present information, respond to questions and facilitate communications regarding CMC updates, program risks, and business impacts across the organization when required.
• Support development, implementation, and adherence to operational procedures throughout the organization.
• Other duties as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS: 

Education: 

• Bachelor’s degree in life sciences or a relevant field. Advanced degree in life sciences preferred.

Experience: 

• 8+ years of hands-on technical experience in biologics manufacturing or development (e.g., process development, cGMP manufacturing, process registration, analytical science), preferably in viral vector production, preferred
• 5 + years of experience in CMC Project Management
• Record of accomplishment of successfully managed CMC projects and personnel
• Leadership and motivational soft skills to maintain naturally high morale within the CMC team
• Ability to communicate effectively at all levels across the organization. Has strength of character to have difficult conversations with senior stakeholders, including customers, internal team members, and senior management; excellent written, verbal, and presentation skills
• Ability to function independently in a fast-paced environment.
• Pragmatic, organized, and results-oriented and with the ability to manage multiple priorities
• Excellent planning, organizational, and controlling skills
• Problem-solving skills - ability to analyze using critical thinking and solve complex issues that do not have routine solutions and propose solutions
• Skilled with Microsoft Project, Teams, and other automated presentations
• Must have sound knowledge of integrated drug development processes in a biopharmaceutical company. Experience with gene or cell therapy programs preferred.
• Ability to manage multiple work streams and projects concurrently.
• Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly.

Skills: 

• Proficient in the Microsoft Suite of programs
• MS Project
• OnePage

Base salary compensation range:

Bay Area Range: $153,000 - $198,000

National Range: $130,000 - $165,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities