About the roleContraline is seeking an experienced leader to serve as the company's single accountable owner for pharmaceutical Chemistry, Manufacturing & Controls (CMC), responsible for defining strategy and driving execution from Phase 3 readiness through regulatory approval, commercial launch manufacturing, and lifecycle management support. Working closely with Quality, Regulatory Affairs, Clinical Development, Program Management, and external partners, this individual will ensure manufacturing, supply, and CMC activities support the company's development, regulatory, and commercial objectives.
The ideal candidate has directly led late-stage pharmaceutical CMC programs in a small or mid-size biotechnology company and combines strategic thinking with hands-on execution. They are comfortable making sponsor-side technical decisions, building fit-for-purpose systems, leading through influence, managing external partners, and delivering high-quality technical outcomes in a fast-paced, resource-conscious environment.
Key Responsibilities- Own sponsor-side pharmaceutical CMC strategy and decision-making from Phase 3 through commercial launch, serving as the company's single accountable leader for manufacturing strategy, regulatory CMC, commercial readiness, and lifecycle management.
- Own sponsor-side technical decisions regarding manufacturing strategy, process changes, comparability, validation strategy, supply risk, and regulatory CMC, ensuring decisions appropriately balance technical, regulatory, timeline, and business considerations.
- Translate CMC gaps, risks, and regulatory expectations into practical execution plans with clear priorities, timelines, resources, owners, and decision points.
- Serve as a hands-on CMC leader who personally advances critical workstreams while coordinating cross-functional execution across development, manufacturing, analytical, regulatory, quality, supply, and commercialization activities.
- Serve as Contraline's internal owner for CMC regulatory strategy, including IND maintenance, health authority interactions, submission readiness, information requests, and future marketing application content.
- Prepare, review, and maintain clear, technically consistent CMC source documents and submission-ready materials.
- Develop CMC strategies for key regulatory meetings and phase-transition decisions, ensuring technical issues are appropriately addressed at the right stage of development.
- Own pharmaceutical manufacturing and control strategy across drug substance, drug product, analytical methods, stability, specifications, comparability, process understanding, and lifecycle management.
- Serve as the primary sponsor-side technical and business lead for external manufacturers, laboratories, suppliers, logistics partners, and CMC consultants.
- Lead technology transfer, manufacturing campaign planning, process validation, supply planning, and commercial readiness while proactively identifying and mitigating manufacturing, quality, and supply risks.
- Build and execute a registration- and launch-enabling CMC roadmap covering validation strategy, commercial supply assumptions, stability commitments, inspection readiness, and post-approval lifecycle management.
- Translate complex CMC issues into clear recommendations for executive leadership while maintaining strong sponsor accountability across external partners.
- Assess CMC aspects of Business Development assets or potential acquisitions as required.
Required Qualifications- BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree preferred but not required with directly relevant experience.
- 15+ years of pharmaceutical or biotechnology industry experience in CMC, pharmaceutical development, technical operations, manufacturing, or related functions.
- Demonstrated experience serving as the sponsor-side CMC lead for a late-stage pharmaceutical development program, including ownership of CMC strategy, external manufacturing, and regulatory interactions.
- Hands-on experience writing, preparing, reviewing, or defending CMC content for regulatory submissions and health authority interactions, including INDs and/or marketing applications.
- Strong working knowledge of FDA CMC expectations, ICH guidelines, cGMP requirements, pharmaceutical manufacturing, analytical development, stability, specifications, and control strategy.
- Demonstrated success working with CDMOs, analytical laboratories, suppliers, consultants, or other external partners in a sponsor-led or virtual biotech operating model.
- Experience translating technical, regulatory, manufacturing, and quality issues into practical execution plans, risk-based recommendations, and clear decisions.
- Proven ability to lead cross-functionally across Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Program Management, and executive stakeholders.
- Strong written and verbal communication skills, including the ability to prepare high-quality technical documents and communicate complex CMC issues clearly to non-CMC audiences.
- Highly organized, self-directed, and comfortable operating in a hands-on, fast-paced, resource-conscious company environment.
Preferred Qualifications- Experience with NDA/MAA preparation, approval, commercial launch, process validation, inspection readiness, or post-approval lifecycle management.
- Experience with topical, transdermal, hormonal, metered-dose, combination product, or device-drug development programs.
- Experience working in small or mid-size biotechnology companies, virtual development models, or sponsor organizations that rely heavily on external manufacturing and consulting partners.
- Experience building or scaling CMC alongside Operations, Quality, Clinical, Commercial teams, and external manufacturing oversight processes.
Characteristics We Value In This Candidate:The ideal candidate is:
- A strategic, hands-on CMC leader who can define the path forward and personally drive critical work to completion.
- A systems thinker who connects science, manufacturing, regulatory strategy, quality, supply, and business priorities.
- Comfortable operating in an entrepreneurial, fast-paced biotechnology company where priorities evolve and resources must be used thoughtfully.
- Equally effective in detailed technical discussions, external partner management, and executive-level decision-making.
- Collaborative, decisive, and able to lead through influence while maintaining clear sponsor accountability.
- Energized by building practical, scalable systems that support late-stage development, commercialization, and long-term company growth.
The pay range for this role is:
200,000 - 275,000 USD per year (Remote (United States))
