Back to jobs
New

Senior Director, Formulation and Drug Product Development

Remote

 

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 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. 

Key Responsibilities 

  • Develop drug product and formulation development strategies to advance clinical assets from Phase 1 through launch and commercialization
  • Develop clinical and commercial formulations and co-formulations for protein therapeutics, including antibodies
  • Define and develop robust biologics drug product manufacturing processes across the portfolio
  • Support clinical studies through clinical dose preparation development, design and oversight of clinical in-use stability studies, and collaborate with cross-functional teams to prepare clinical study documentation such as Pharmacy Manuals and Investigator Brochures
  • Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, autoinjector, and advanced delivery technologies.
  • Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support
  • Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members
  • Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process validation, and commercial readiness
  • Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
  • Analyze and trend stability data to evaluate formulations and product shelf-life
  • Analyze manufacturing data and identify opportunities for process improvement and optimization
  • Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
  • Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Ideal Candidate 

  • 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

The anticipated salary range for candidates for this role will be $235,000 - $270,000/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
  • 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.
 
To review our privacy policy, click here

 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
From the list below, please select which areas you have direct prior experience with: *
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Apogee Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.