Director, CMC Product Development - Small Molecule

Beeline Medicines; Durham (NC); Híbrido; USD 199 000 - 258 000; Tempo integral

Resumo da oferta

Beeline Medicines is seeking a Director, CMC Product Development – Small Molecule. Lead end-to-end development from formulation to regulatory submission, partnering with CDMOs and internal teams.

The role demands deep expertise in solid oral dosage forms, QbD/DoE, and a proven track record in pre-commercial settings. Hybrid work with approx. two on-site days weekly and potential travel.

Qualificações

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or closely related discipline preferred, or equivalent industry experience.
• 10+ years of pharmaceutical drug product development and manufacturing experience focused on small molecules.
• Primary scientific lead on formulation and drug product process development from early to late clinical phases.
• Deep expertise in solid oral dosage form development (IR, modified release, amorphous solid dispersions).
• Experience managing external partners (CDMOs, contract labs) with oversight and change control.
• Knowledge of ICH Q8/Q9/Q10/Q11, cGMP, FDA/EMA expectations for drug product development.
• Experience authoring drug product sections of INDs/IMPD/NDA filings and responding to authorities.
• Proven ability to operate in a pre-commercial, resource-constrained environment.
• Strong cross-functional stakeholder management and executive communication.
• Willingness to travel ~20%+ as needed.

Responsabilidades

• Define and execute drug product development strategy for small molecule programs.
• Lead formulation development across all clinical phases and select final composition.
• Direct drug product process development, tech transfer, scale-up, and validation.
• Interface with CDMO teams, overseeing scope, quality, and timelines.
• Author/Review regulatory sections on drug product topics and respond to authorities.
• Apply QbD and DoE to establish CQAs, CPPs, and design spaces.
• Collaborate with Analytical Development on release and stability specs.
• Lead packaging development and container-closure system selection.
• Support clinical supply planning with timelines and batch projections.
• Evaluate dosage form strategies and manufacturability in candidate selection.
• Contribute to CMC due diligence and portfolio planning.
• Perform other duties as assigned.

Conhecimentos

Formulation development

Drug product development

CDMO management

Regulatory submissions

QbD & DoE

Cross-functional leadership

Project management

IND/IMPD/NDA/NDA filings

cGMP knowledge

Travel 20%+

Formação académica

Ph.D. in Pharmaceutical Sciences or related

Descrição da oferta de emprego

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

Job Summary

The Director, CMC Product Development – Small Molecule is a senior technical and operational leader responsible for the end‑to‑end CMC development of small molecule drug product candidates, from early formulation through process development, clinical supplies, and regulatory submission. Reporting to the Executive Director, CMC Product Development, this individual drives the drug product development activities on assigned programs. This role carries no direct reports but works cross‑functionally with internal teams and external CDMO drug product partners. It requires deep expertise in small molecule formulation science and manufacturing, experience in taking programs through late‑stage development and filing, and ability to make sound technical decisions in a pre‑commercial biotech environment.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week — currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties And Responsibilities

• Define and execute drug product development strategy for assigned small molecule programs, including formulation approach, manufacturing platform, and the development roadmap required to support the clinical and regulatory plan.
• Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing.
• Direct and oversee drug product process development, technical transfer, scale‑up, process optimization, registration batch execution, and process validation / PPQ for solid oral dosage forms (tablets, capsules) and other small molecule drug delivery systems.
• Serve as the primary technical interface with CDMO drug product teams for assigned programs, defining the scope of activities, providing scientific oversight of formulation and manufacturing campaigns, document review, and deviation resolution. Hold partners accountable to quality and timeline commitments.
• Author and review drug product sections of regulatory submissions (IND, IMPD, NDA, MAA) including formulation descriptions, manufacturing process narratives, container‑closure justifications, control strategies and process validation approaches. Lead the technical response to FDA and EMA questions on drug product topics and support health authority meetings.
• Integrate Quality by Design (QbD) principles and Design of Experiments (DoE) into formulation and process development decisions, establishing critical quality attributes (CQAs), critical process parameters (CPPs), and design spaces.
• Collaboration with Analytical Development to define drug product release and stability specification, in‑process controls, and comparability strategies for formulation and process changes.
• Lead packaging development and container‑closure system selection for clinical and commercial drug product presentations, including compatibility assessment, and child‑resistant packaging requirements.
• Contribute to clinical supply planning by providing manufacturing timelines, batch size projections, and drug product release schedules to the Clinical Supply Chain function in support of trial startup, enrollment milestones and uninterrupted clinical supply.
• Evaluate drug delivery technology options and novel dosage form strategies for pipeline candidates, providing formulation feasibility assessments and manufacturability input during candidate selection and early development planning.
• Contribute to CMC due diligence assessments and portfolio planning by evaluating the manufacturability and development feasibility of small molecule drug product candidates.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related discipline preferred, or equivalent industry experience.
• 10+ years of pharmaceutical drug product development and manufacturing experience focused on small molecules in pharmaceutical or biotechnology industry.
• Demonstrated track record of serving as the primary scientific lead on formulation and drug product process development programs from early to late clinical phases.
• Deep technical expertise in solid oral dosage form development (immediate release, modified release, amorphous solid dispersions), including formulation selection, manufacturing process development, scale up, technical transfer, commercial process optimization, and validation.
• Proven experience in selecting and managing external partner relationships (CDMOs and contract laboratories), including technical oversight, work order management, change control, deviation resolution, and performance monitoring.
• Comprehensive knowledge of ICH Q8/Q9/Q10/Q11, cGMP requirements and FDA/EMA drug product development expectations.
• Experience authoring drug product sections of INDs, IMPDs, and NDA filings and contributing to FDA or EMA responses on formulation, manufacturing, and drug product control strategy topics.
• Proven track record of operating effectively in a pre‑commercial, resource‑constrained environment — balancing strategic vision with hands‑on execution and infrastructure building.
• Experience managing cross‑functional stakeholder relationships at the senior level, with the ability to influence without authority and align diverse teams around shared program goals.
• Strong written and verbal communication skills, with a track record of authoring high‑quality regulatory documents, scientific reports, and executive‑level presentations.
• Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Clinical Pharmacology, Regulatory Affairs, and Quality in a team‑oriented environment.
• Organized and detail‑oriented communicator who can manage competing priorities, proactively flag risks, and keep cross‑functional stakeholders aligned on timelines and deliverable status.
• Position may require ability to travel 20%+ as needed of time or more including occasional overnight stay driven by business need.

Salary Range

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by applicable local law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$199,000 - $258,000 USD

Benefits

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy – Beeline Medicines