Sr. Scientist, Purification Development

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking a Sr. Scientist, Purification Development to join the Development, Manufacturing, and Supply team. This newly created role will be responsible for working with CDMO(s) to develop processes that enable robust production of drug substance (DS) and drug product (DP) for protein-based biologics. This interdisciplinary position will provide stewardship of cell culture and/or purification processes, including scale-up from lab to manufacturing scale. Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities. You will be responsible for advancing drug candidates through clinical development, including development of second-generation processes and resupply as appropriate.

Key Responsibilities

• Collaborate with CDMOs to guide process development of protein production from lab-scale to tech transfer and GMP manufacture
• Analyze process and manufacturing data to understand and optimize process performance
• Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations
• Review GMP and non-GMP technical documentation (batch records, SOPs, protocols, and reports)
• Author and review internal procedures, reports, and presentations
• Interface with Research, Development, Quality, and Manufacturing colleagues to advance clinical programs from Discovery to FIH trials
• Collaborate cross-functionally to support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
• Assist in developing phase-appropriate product understanding and control strategies using QbD framework
• Contribute to late-phase development strategy to support potential commercialization
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

Ideal Candidate

• PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering or relevant field) or MS with commensurate years of education and experience
• 4+ years’ experience in biologics downstream process development and manufacturing
• Expert in purification processes for the production of therapeutic proteins
• Developed scalable and robust purification processes for multiple biologics programs
• Experience in the following:
  • Design of experiments, data analysis, and data interpretation
  • Statistical analysis and model creation
  • Scale down qualification of purification unit operations
  • High throughput screening methods for purification processes
  • Experience with cGMPs and tech transfer to CDMOs
  • Supporting campaigns and identifying trends through sophisticated analysis of manufacturing and process development data
  • Working with late-stage biologics programs, including process characterization studies, process validation, and risk management (e.g., FMEA)
• Demonstrated aptitude in collaborating cross-functionally with analytical, formulation/drug product/device manufacturing, and/or supply chain is required
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Ability to multi-task and keep pace with a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Willing to travel up to 25%

What We Offer

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and E
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee holds All Team meetings during the year to build relationships and problem solve

The anticipated salary range for candidates for this role will be $140,000 - $160,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.   

What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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