Position OverviewAs we prepare for our next stage of growth and clinical advancement, Celea is seeking
an experienced, strategic, and hands-on Director, Product Steward, CMC to serve as the end-to-end technical owner for drug substance and drug product manufacturing across the product lifecycle. Reporting to the
Senior Vice President, CMC, this role will own drug substance and drug product manufacturing for assigned products, while personally driving technical decision-making, manufacturing oversight, and the resolution of complex process and product issues.
In the near term, the focus will be ensuring successful execution of manufacturing campaigns and uninterrupted supply as deupirfenidone (LYT-100) advances through late-stage development. Over time, this person will strengthen process robustness, support global regulatory submissions, and help build the manufacturing and supply foundation for commercialization, and will be instrumental in guiding Celea through its next chapter.
This position is based in Boston, Hybrid with 3 days/onsite.
Key Responsibilities- Serve as the technical owner for drug substance and drug product manufacturing.
- Provide scientific and technical oversight of internal and external drug substance and drug product manufacturing, including review and approval of batch records, manufacturing investigations, technical and process performance reports, and technology transfer documentation.
- Lead manufacturing campaign planning, execution, and post-campaign assessments, and drive resolution of complex manufacturing, process, and product-related issues.
- Identify technical and supply risks and deliver mitigation strategies that protect product quality and ensure uninterrupted supply to patients.
- Partner with Global Supply Chain on demand forecasting, supply planning, inventory management, and manufacturing scheduling, and provide technical input to long-range manufacturing and supply strategies.
- Serve as the primary CMC representative for manufacturing within cross-functional teams, partnering with Analytical Development, Quality, CMC Regulatory, Global Supply Chain, and CMC Program Management to drive decisions on process changes, investigations, comparability assessments, and validation programs.
- Partner with CMC Regulatory Affairs to support relevant global regulatory submissions, and approve CMC documentation and support health authority inspections, inquiries, and responses.
- Ensure GMP compliance in partnership with Quality Assurance and Quality Control, supporting change controls, deviations, CAPAs, product quality reviews, and risk assessments.
- Drive continuous improvement in process robustness, reliability, and efficiency - including thoughtful use of AI and automation - and contribute to budget planning, manufacturing cost management, and evaluation of external manufacturing partnerships.
QualificationsRequired- Ph.D., M.S., or B.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Chemistry, or a related scientific discipline; equivalent experience considered.
- 12+ years of experience in biopharmaceutical or pharmaceutical development and manufacturing, including significant experience in drug substance and drug product manufacturing, technical operations, process development, or manufacturing sciences.
- Demonstrated expertise in GMP manufacturing, process validation, technology transfer, and lifecycle management.
- Track record of supporting regulatory submissions and health authority interactions for clinical and commercial-stage products.
- Strong scientific and technical leadership, with the ability to influence and drive decisions across a matrix organization and to balance technical, regulatory, operational, and financial considerations.
- Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.
- Proficiency using AI tools to work smarter - curiosity about how technology can improve the quality and speed of your work.
Preferred- Experience working with CMOs/CDMOs and global manufacturing networks.
- Experience in respiratory or other fibrotic disease programs, or with small-molecule products in late-stage development.
Why Join Celea Therapeutics- Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases.
- Shape the foundation of a Phase 3-ready biotech poised for significant growth.
- Collaborate with a passionate, mission-driven leadership team.
- Competitive compensation and equity package.
CompensationTransparency is one of our values, and that includes how we pay. The anticipated salary range for this role is
$220,000 - $235,000 plus bonus and equity. Where an offer lands within the range reflects the candidate's experience, skills, and internal equity - and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.
Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation.
Base Pay Information
$220,000-$235,000 USD
