About the Company:
Clarity Pharmaceuticals is a leading radiopharmaceutical company developing Targeted Copper Theranostics (TCTs) for the treatment of serious diseases. TCTs leverage the pairing of Cu-64 for diagnosis and Cu-67 for therapy. As we advance our clinical pipeline toward commercialization, we are growing our team to support that expansion. We operate as a lean, fully remote, multi-disciplinary team spanning the United States and Australia, where members support one another across a range of activities. We are looking for someone motivated to take on new challenges and excited to help grow the company.
About the Role:
Clarity’s peptide supply sits on the critical path to commercialization. As our pipeline scales, the technical and operational demands of peptide manufacturing also continue to grow. As Associate Director, External Manufacturing (Peptides), you will be the single point of technical and operational accountability for the execution of external manufacturing and related supply activities and how Clarity’s peptides get made. You will own relationships with the CDMOs who manufacture them, lead the transfer and scale-up of processes from Clarity to those partners, and make the day-to-day calls that keep clinical and commercial supply moving. This is a hands-on, high-autonomy role in a growing company. You will work directly with Quality Assurance, Regulatory Affairs, R&D, Supply Chain, and Finance as the person in the room with deep peptide manufacturing expertise. The work requires managing several parallel priorities, comfort with ambiguity, and the judgment to know when to escalate and when to decide. This role will be reporting to the Head of Cold Manufacturing within the Operations function.
Key Responsibilities:- Serve as the primary technical leader for peptide manufacturing processes, including synthesis and purification, resolving complex technical challenges and driving initiatives to improve robustness.
- Oversee the transfer of peptide processes from Clarity to CDMOs, ensuring successful scale-up, validation, and regulatory compliance.
- Ensure timely and effective execution of all manufacturing and supply plans at assigned CDMOs.
- Build and maintain productive relationships with external contract manufacturers (CMO’s), and internal global colleagues
- Play a key role in the selection and onboarding of new CDMOs, technical transfers, operationalizing product supply, and site establishment.
Lead investigations into manufacturing deviations, non-conformances, and out-of-specification results, implementing effective corrective and preventive actions (CAPAs).Review technical reports, protocols, process documentation, specifications and regulatory submissions related to peptide manufacturing processes and product quality.
Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure efficient process execution and product delivery.
Manage and track peptide inventory, perform inventory reconciliations, and support the month-end close process.
Stay abreast of industry best practices, emerging technologies, and regulatory requirements related to peptide manufacturing and analytical methods.
Required Qualifications:- PhD in Chemistry, Biochemistry, or Chemical Engineering with 8+ years of relevant industry experience; or a Master’s or Bachelor’s degree in a related discipline with equivalent depth of experience
- Substantial experience in pharmaceutical or biotechnology manufacturing with a focus on API processes, gained in a cGMP environment
- Proven experience in successful management of external manufacturing at partner CDMOsHands-on experience with peptide manufacturing processes (for example, solid- or solution-phase synthesis and purification), or closely transferable synthetic API process experience.
- Strong working knowledge of cGMP regulations, ICH guidelines, and regulatory expectations for API manufacturing.
- Ability to travel domestically and internationally about 25% of the time
Preferred Qualifications:
Extensive experience with process validation, technology transfer, and regulatory filings (IND/NDA) is highly preferred.
Strong project management skills, with experience leading cross-functional teams and managing complex projects.
Excellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and concisely to diverse audiences.
Experience in radiopharmaceuticals, or with chelator or conjugation chemistry.
Clarity Pharmaceuticals is an equal opportunity employer. We welcome applicants from all backgrounds and are committed to building an inclusive, remote-first team across the US and Australia.
