Associate Director, QC Manufacturing Support

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 an Associate Director, QC Manufacturing Support to provide GMP raw materials testing program management and to additionally support drug substance process-related analytical testing activities as a liaison to Apogee’s DS, DP, and MSAT teams. The ideal candidate has deep technical expertise and understanding of GMP raw materials QC testing management and regulatory expectations, is competent and experienced operating in GMP quality management systems and has experience with analytical in-process testing for biologics (e.g., protein concentration, titer, etc.).

Responsibilities may include:

• Author internal raw materials testing specifications, specifically for non-compendial raw materials

• Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation

• Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites

• Review and assess impact of vendor change notifications related to GMP raw materials; partner with internal and external stakeholders to development plans for material changes with major impact

• Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing; may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management

• Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required

• Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing

Preferred Qualifications:

• BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)

• 10+ years of biotech industry experience in QC operations or analytical support roles with at least 6 years demonstrated experience supporting a GMP raw materials testing program

• Understanding of analytical techniques relevant to monoclonal antibody testing

• Experience in relationship management with external analytical test sites

• Ability to effectively prioritize and manage multiple projects

• Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing

• Excellent communication skills; able to collaborate effectively across multidisciplinary teams

• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

The anticipated salary range for candidates for this role will be $160,000-$180,000/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

• 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

• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

• 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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