Back to jobs

Associate Director, GMP Quality Assurance

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 dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team. This key role will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes. This position will work closely with cross-functional teams to establish, maintain, and continually improve Apogee’s quality systems. This role is essential in supporting our mission to develop and deliver differentiated biologic therapies to patients in need. The position will report to and partner closely with the Head of GMP QA.

Key Responsibilities 

  • Assist in the development and execution of planned QA audit schedules supporting GMP activities
  • Independently perform assigned GMP audits
  • Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated
  • Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement
  • Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products
  • Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
  • Provide QA support for upstream manufacturing (master cell bank, drug substance, and drug product) and downstream manufacturing (packaging and labeling) activities
  • Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events
  • Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
  • Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
  • Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
  • Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
  • Ensure personnel are adequately trained in GMP requirements and quality procedures
  • Maintain comprehensive and accurate records and reports related to quality assurance activities
  • Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety
  • Assist in GMP inspection readiness activities to support regulatory authority inspections

Ideal Candidate 

  • A Bachelor's degree in a relevant scientific discipline or equivalent is required
  • Advanced degree is a plus
  • A minimum of 7 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics
  • Auditing of GMP facilities is desired
  • In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
  • Experience with analytical instrumentation, methods, validation, and investigations including stability program management
  • Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
  • Strong communication (oral and written), and effective interpersonal skills with the ability to influence and drive change
  • Excellent problem-solving and critical thinking abilities
  • Flexible and creative to meet the needs and challenges of a growing, dynamic company
  • Focus on fostering a culture of collaboration and teamwork
  • Ability to manage multiple projects with aggressive timelines and changing priorities
  • Ability and willingness to travel up to 20% per year including all company meetings

The anticipated salary range for candidates for this role will be $170,000-$190,000. 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.
 
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...
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.