Scientist, Formulations and Drug Product 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."

We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.

If this sounds like you, keep reading!

Role Summary

We are seeking a Scientist, Formulations and Drug Product Development to join the TechOps team to develop advanced protein formulations, support progression of clinical candidates, and to innovate to enhance our drug product portfolio. This role will support activities for formulation development, drug product process development and manufacturing to enable robust production of Drug Substance (DS), Drug Product (DP) and placebos for protein-based biologics. This role will be based at Apogee's Boston-based lab in Seaport and is primarily lab-based. This position will be a key element of an integrated PD and MFG team and will work closely with team members involved in device development, analytical development, as well as cell line development, cell culture and/or purification processes, including scale-up from lab to GMP manufacturing, to ensure a seamless, highly integrated TechOps team.

Key Responsibilities

• Design and develop robust, high concentration antibody formulations, co-formulations and placebos
• Working with the device team, develop drug product presentations in vial, pre-filled syringe, and/or autoinjector configurations for product quality impact
• Optimize formulations for yield, syringability, compatibility, stability, and shelf life
• Planning and executing stability studies in collaboration with the analytical team, employing analytical techniques to evaluate particle characteristics, physicochemical properties, and stability-indicating attributes
• Maintain accurate and detailed documentation of experiments, results, and protocols
• Troubleshoot to identify root causes, corrective actions, and support deviation resolution
• Analyze data using appropriate data reduction/ processing software
• Communicate findings and progress through presentations and technical reports
• Aliquot, receive, and ship non-GMP and GMP samples
• Collaborate effectively with other cross-functional teams, including pre-clinical, supply chain, quality assurance, and regulatory affairs

Ideal Candidate

• PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering or relevant field) or MS in relevant discipline with 3+ years' experience
• Prior biologics development and manufacturing experience
• Hands-on experience in executing stability studies, formulation stress studies and process development studies
• Working knowledge and direct experience working with analytical techniques such as sub-visible particle testing (HIAC/MFI), SoloVPE, HPLC/UPLC, cIEF, CE-SDS, DLS, DSC and viscometers
• Proficiency in using Microsoft tools- MS Excel, PowerPoint, Word as well as data analysis software such as GraphPad and/or Origin
• Ability to think creatively, work independently and multi-task in a fast-moving organization
• Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless
• Availability to participate in calls across multiple international time zones
• Ability and willingness to travel up to eight times a year for company-wide meetings as well as Tech Ops team meetings
• This position is based in our Boston-based laboratory / office in Boston's Seaport district. Must be able to work 100% onsite.

The anticipated salary range for candidates for this role will be $120,000 - $140,000. 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

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• 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 offers regular all team, in-person meetings to build relationships and problem solve

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

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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