Director Formulation Development Jobs in California

Description

ABOUT THE COMPANY

Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardioendocrine diseases. 

 Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of leading life science investors including Sofinnova, Forbion, Xontogeny/ Perceptive Advisors, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. 

The company's lead program, MAR001, is a monoclonal antibody targeting ANGPTL4, a genetically validated target with potential to address the subset of patients at the highest risk of adverse cardiovascular events, despite current standard of care therapies.   MAR001 is rapidly progressing through Phase 2b clinical development.   Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly.  MAR002 has potential to become best-in-disease and is rapidly progressing through Phase 1 clinical development.  We also have a third asset that is rapidly advancing through research discovery, with DC nomination expected next year.

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is "Hands-On", and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results. 

ABOUT THE ROLE

This is a key role within the first phase of hiring for our Technical Operations team as we aggressively advance the first program towards late-stage development and our second program into early-stage clinical development, with additional programs in discovery.  This role will report to the CTO.  The successful candidate will oversee formulation development, drug product development and manufacturing, transition from vials to prefilled syringe for all of Marea's development programs.   Successful candidate will develop CMC strategy for formulation and drug product working cross functionally across other technical operations functions and also work closely with clinical development, clinical operations and program teams to ensure that the product profile and configuration is consistent with the target profile needed for the clinical study and ultimately for commercial launch. In addition to the strategic responsibilities, candidate will have operational responsibility to provide technical and day-to-day oversight of our CDMOs and other external partners conducting formulation and drug product development and own critical technical decisions around formulation selection and drug product presentations for the entire portfolio.  Candidate will also plan future tech transfer and drug product manufacturing strategy, develop and execute life cycle plans and ensure these are integrated into the cross functional project team as well as the financial operating plans.  While the role is primarily focused on formulation and drug product development,  this is a leadership role that is expected to influence and guide the overall CMC development especially considering that many of the CMC challenges for our portfolio products are centered on formulation and drug product.  The scope of the role will also include discovery programs, that are expected to approach drug candidate nomination, where the candidate is expected to provide molecular and formulability assessment, and biophysical characterization, to impact the selection of the candidate molecules.  The role is also expected to contribute to drug product comparability and analytical characterization as part of the CMC life cycle management. This role is viewed as a senior member of the technical operations team and will be a keep voice in guiding the evolution of the department with respect to CMC strategy and the growth of the team in anticipation of various strategic scenarios.  As such, the scope of this role is expected to evolve accordingly. 

Requirements

KEY RESPONSIBILITIES

 Accountable for formulation and drug product development strategy and execution for the entire Marea portfolio which includes monoclonal antibodies in early and late-stage CMC development and other modalities in discovery.

 Develop a holistic drug product, formulation and device strategy for each of Marea's asset keeping in mind clinical/patient experience, commercial opportunity and regulatory considerations.

 Design/execute (with the external CDMO partner) pre-formulation and formulation studies with a focus on stability, manufacturability, and patient-centric delivery.

 Develop scalable drug product processes for all formulations; lead scale-up and tech transfer to CDMOs. Provide technical oversight of the operations at the CDMOs

 Drive development of combination products, including pre-filled syringes; experience with autoinjectors is a strong plus.

 Author/review CMC sections of regulatory document (ex., INDs, IMPDs, and BLAs).

 Partner closely with internal stakeholders (Analytical, Process Development, Quality, Regulatory, Clinical) to ensure cross functional alignment of key assumptions around formulation and drug product

 Manage external partners (CDMOs, CROs) to execute formulation and fill-finish activities, including oversight of timelines, budgets, and technical deliverables.

 Identify, plan and complete necessary product and container compatibility, leachables and extractables studies necessary for the stage of the regulatory submission

 Contribute strategically and scientifically to CMC planning and risk mitigation across programs.

 Be hands-on where needed and adaptable to the evolving needs of a dynamic startup environment.

 Oversee tech transfer and manufacturing of drug product manufacturing at CDMOs

 Lead and deliver process characterization and validation studies leading upto the BLA, including other BLA enabling activities related to drug product and formulation

 Collaborate with discovery teams for early molecular and formulability assessment to guide selection of future drug candidates

 Identify and generate drug product comparability and analytical characterization as part of the CMC life cycle management 

 PhD or MS in Pharmaceutics, Biochemistry, Chemical/Biomedical Engineering, or related field.

 15+ plus years (PhD) of relevant industry experience in formulation and drug product development of biologics.

 Deep understanding of protein formulation principles, stability challenges, and container/closure compatibility

 Solid understanding of various drug product configurations including vials, prefilled syringe (Autoinjector familiarity a plus)

 Experience in early-phase development (preclinical/IND) with strong knowledge of regulatory expectations; late-stage/BLA experience is a plus.

 Demonstrated success working in fast-paced, resource-constrained environments with a solutions-first mindset.

 Strong communication skills and ability to work across disciplines and with external partners.

 Comfortable wearing multiple hats and contributing both strategically and tactically.

PAY RANGE

The salary range for this role is $275,000 - 315,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.

WORKING CONDITIONS 

 The role may need to occasionally work in laboratory environment.

 Travel to CDMOs/CTLs may be needed up to 10% of the time (variable, with some peak windows)

We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.