Senior Director, Formulation and Drug Product Development

March 6

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• We are seeking a Senior Director, Formulation and Drug Product Development to develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization. • Reporting to the Vice President, Formulation and Drug Product Development, this role requires significant expertise in protein drug product development including formulation development, process development, aseptic manufacturing, support of clinical studies, quality and regulatory compliance, and ability to collaborate with cross-functional teams and external partners to deliver on drug product supply and development. • Embedded in the Formulation and Drug Product Development team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will work closely with team members involved in drug substance development, device development, analytical development, and supply chain.

🎯 Requirements

• Minimum of 15 years industry experience in drug product development and manufacturing • PhD in relevant discipline (eg, chemical engineering, biochemical engineering, chemistry or related field) • Significant experience with formulation development of recombinant proteins, including antibodies • Significant experience in biologics drug product process development and aseptic manufacturing • Experience with prefilled syringe dosage forms and combination products • Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations • Track record of advancing assets from pre-clinical through IND and into late phase development • Experience with process validation and commercialization of biologics is preferred • Experience with clinical study support including clinical dose preparation, clinical in-use studies, and support of Pharmacy Manual and/or Investigator’s brochures preferred • Extensive experience with cGMPs and knowledge of regulatory guidance • Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory • Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams • Availability to participate in calls across international time zones • Ability and willingness to travel up to 25%, including frequently to the Apogee lab in Boston

🏖️ Benefits

• 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