The Vice President of Drug Product Formulation Discovery & Development will serve as the scientific and strategic leader for the discovery, development and optimization of early-phase drug product formulations, with a primary focus on first-in-class co-formulation combining multiple monoclonal antibodies and oligonucleotide as active therapeutic ingredients. Reporting to the CSO, the VP will establish and lead the company’s internal formulation discovery and development team and an external network of specialized CDMOs to discover, screen, and optimize liquid and lyophilized presentations that meet the highest standards of stability, manufacturability, and regulatory compliance. The VP will set the technical vision, oversee end-to-end formulation strategy, and ensure seamless integration of formulation discovery & development with inventive creativity, coupled with analytical, manufacturing, device, and clinical programs to enable rapid advancement through clinical phases toward commercialization.

QUALIFICATION REQUIREMENTS:

• Education:
• Ph.D. degree in Pharmaceutical Sciences or related field
• Experience:

15 + years in biopharma formulation & drug-product discovery & development with

• 8 years at Director/VP level.
• Track record forming liquid and/or lyo biologic products from discovery through Phase 2 in the pharmaceutical or biotechnology industry in the field of pharmaceutical development with emphasis in biological drugs, with strong preference for antibody drugs, including process development and manufacturing of biological drug substance, drug product, formulation development and analytical testing.
• Expert knowledge of advanced principles, concepts, and theory related to pharmaceutical sciences applied to product and process development.
• Hands-on experience in protein & oligonucleotide co-formulation science, high-concentration/viscous systems, lyophilization cycle design, aseptic/isolator operations, combination-product considerations (device integration).
• Familiarity with FDA, EMA, NMPA, and ICH guidance for phase-appropriate DP development; experience in early HA interactions and PIND/Type-C meetings. Extensive knowledge of cGMP/GLP ICH and FDA guidelines.
• Oncology and/or combination drug/device experience preferred.
• Experience managing multiple CDMOs across geographies
• Knowledge/Skill:
• Strategic and “out of the box” thinker able to thrive in a fast-paced start-up; proven talent-builder; excellent cross-cultural communication (Mandarin a plus); budget stewardship and vendor-negotiation skills.
• Excellent leadership, organizational and project management skills.
• Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
• Must have outstanding communication and collaboration skills within cross-functional teams and external organizations.
• Demonstrated ability to write technical and scientific documents.
• Ability to work in a fast-paced virtual environment.
• Excellent verbal and writing skills.
• Excellent editing and proof-reading skills.
• Possess a self-directing, self-starting work ethic.
• Excellent knowledge of the competitive environment for drugs in the immuno-oncology marketplace and in research and development pipelines.
• Flexibility to travel domestically and internationally.

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

Strategic Leadership

• Define and communicate a drug product formulation discovery & development roadmap and vision aligned with corporate objectives, risk profile, funding strategy and commercial goals.

Formulation Discovery

• Set the scientific vision, road-map, and decision gates for the discovery of novel antibody/oligonucleotide co-formulations, including excipient risk assessments, high-throughput screening cascades, and device compatibility.
• Define Target Product Profile (TPP) and Critical Quality Attributes (CQAs) in partnership with Analytical Development, Clinical and Commercial teams.
• Be an “out of the box” thinker who is passionate about the discovery phase process, and potentially discover valuable intellectual property.
• Evaluate emerging formulation technologies (e.g., high-concentration viscosity-reduction excipients, sustained-release depots, nano-emulsions, etc) and academic collaborations to solve co-formulation challenges.
• Evaluate intellectual property landscape and provide competitive intelligence input

Cross-Functional Leadership

• Chair the formulation governance committee; provide regular updates to the late phase CMC Team and Executive Management.
• Maintain tight alignment with groups of Drug Product Manufacturing, Drug Substance Manufacturing, Analytical Chemistry, Device Engineering, Clinical Supply, Regulatory, and Quality to ensure integrated CMC strategy and risk mitigation.

Early-Phase Development & CDMO Oversight

• Early-stage biophysical and biochemical profiling of candidate molecules (especially oligonucleotides in a protein-rich formulation) to flag stability or compatibility risks before formal formulation screening.
• Lead screening and design-of-experiments (DoE) studies to evaluate aggregation/solubility, viscosity, and stability across liquid and lyo formats; down-select lead formulations based on manufacturability and commercialization considerations.
• Evaluate feasibility of coformulations of different presentations, integrating information of physical chemical properties, formulation science, engineering, analytical chemistry, and device technical information in conjunction with the project strategy, with full consideration of current regulatory and compliance requirements.
• Design and develop manufacturing processes of coformulated drug products to support clinical trials, registration, and commercial product launch.
• Select, negotiate, and technically manage formulation CDMOs for small-scale development batches and early GMP runs, tech-transfer packages, and lyophilization cycle development.
• Build data packages to support IND/IMPD submissions, including Module 3 authoring of DP-formulation sections and responses to early health-authority queries.

Analytical & Stability Interface

• Partner with the Analytical Chemistry Team to develop and qualify phase-appropriate and stability indicating assays (e.g., SEC-HPLC, cIEF, CE, LC-MS, subvisible particles, DLS, etc) that reveal aggregation or degradation pathways and comparability across formulation variants.
• Own the accelerated and long-term stability program (ICH Q1A-R2) for lead and back-up formulations; drive real-time trending and predictive modelling for shelf-life projections.

People & Budget Management

• Recruit, coach, and retain a team of formulation discovery and development scientists and project managers (~2-5 FTEs) that will oversee of external discovery and development activities.
• Build and manage an annual operating budget covering screening studies, CDMO contracts, material transfer, method transfer, and stability testing; present scenario-based forecasts to Finance.

III. Supervisory Responsibilities

• Direct reports: Director(s) DP Formulation Development; Assoc. Dir/Mgrs. Formulation, CMC Project Manager.
• Indirect reports: CDMO formulation scientists & engineers; external consultants.