Manager/Sr. Manager, Peptide External Manufacturing

Manager/Sr Manager, Peptide External Manufacturing

Location: Boston, MA (Hybrid)

Your Purpose:

Alpha-9 is seeking a Manager/Senior Manager, Peptide External Manufacturing to join our growing organization. Our team is looking for an experienced candidate to lead the development, and manufacturing of peptides and small molecules to support our clinical-stage programs.

We are an early-stage company, so this is a highly visible and impactful role in our growing organization. The ideal candidate will be a self-starter with the desire to collaborate cross-functionally. This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment.

What You'll Do:

• Manage external CDMO partners and supplier relationships from initial project proposal through delivery of materials. Track peptide/small molecule vendor metrics and costs.
• Drive on time delivery of materials from CDMO vendors for preclinical development, validation, and clinical activities in line with program timelines
• Review proposed synthetic routes from external vendors and, where necessary, collaborate with external vendors on process improvements
• Drive and communicate specifications and required phase appropriate QC testing
• Review experimental data from internal teams and external CDMO partners. Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations. Drive the authorship, review, and approval of technical documents and reports
• Leverage and manage external consulting subject matter experts on matters concerning peptide and small molecule precursors, including CMC regulatory experts
• Lead and supervise the cGMP manufacture, vialing, testing, and release of materials for use in clinical trials
• Author CMC documents for IND and CTA regulatory submissions
• Collaborate with cross-functional internal teams (Project Management, R&D/Discovery, Pre-clinical, Quality Assurance, Clinical, and Regulatory) to achieve CMC program goals and timelines
• Develop and take ownership of short-term and long-range CMC project plans for peptide/small molecule development and manufacturing and budgets. Communicate progress and propose changes in timeline, objectives, or direction
• Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays

What You Bring:

• PhD/MSc in Chemistry
• Minimum of 5 years of experience in the pharmaceutical or biotechnology industry
• Demonstrated experience in peptide or small molecule synthesis
• Strong oral and written communication skills, and interpersonal skills
• Ability to lead and execute complex scientific projects. Strong analytical and troubleshooting skills
• Experience with cGMP manufacturing
• Experience with lyophilization parameter optimization is considered an asset
• Experience with authoring regulatory submissions and responding to regulatory questions is considered an asset
• Experience with radiopharmaceutical precursor development is considered an asset
• Ability to travel (domestic and international)

What We Offer:

• Competitive Salary, Bonus, and Equity
• Health, dental and vision benefits
• Retirement Savings Plan with 3% employer match
• 20 vacation days
• 16 Holidays
• 5 Sick Days
• Commuter Reimbursement
• Short Term Disability
• Long Term Disability
• Life Insurance
• Technology allowance
• Impactful rewarding work

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.