Senior Director, Analytical Development
Apply NowCompany: Apogee Therapeutics
Location: Boston, MA 02115
Description:
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 of Analytical Development to be responsible for analytical method development and product characterization activities across Apogee's pipeline. In this newly created position you will play a key role in driving the TechOps strategy.
Key Responsibilities
Ideal Candidate
The anticipated salary range for candidates for this role will be $250,000-$270,000 per 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
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
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 of Analytical Development to be responsible for analytical method development and product characterization activities across Apogee's pipeline. In this newly created position you will play a key role in driving the TechOps strategy.
Key Responsibilities
- Lead analytical method development and characterization activities in support of monoclonal antibody pipeline programs
- Partner with new and existing non-GMP testing labs managing all relationships and activities; lead external lab section, taking part in due diligence visits and evaluations, as needed
- Manage and oversee the logistics of in-house analytical activities taking place at Apogee's non-GMP lab in Boston; these activities include the development of analytical test methods, formulation support and product characterization
- Develop methods for drug substance and drug product characterization and testing, including method qualification and troubleshooting.
- Design characterization and comparability studies in collaboration with relevant stakeholders (e.g., QC, Process Development, and Manufacturing)
- Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
- Collaborate with late-stage discovery and facilitate the efficient progression of therapeutic candidates into IND-enabling CMC development
- Devise and execute analytical strategies for moving therapeutic candidates from early to late stage and commercial product development, including oversight of BLA-enabling characterization activities
- Work closely with TechOps Program management and external stakeholders to execute analytical development activities according to program needs
Ideal Candidate
- PhD in relevant discipline (e.g., analytical chemistry, biochemistry or biophysics)
- 15+ years of analytical development experience with complex biologics, particularly monoclonal antibodies, spanning early and late-stage development
- Proximity to the Boston area with the ability to be on-site, as needed, to effectively manage in-house analytical activities
- Experience with regulatory filing preparation and messaging
- Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
- Strong leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
- Strong executive presence and operational mindset
- Ability to multi-task and keep pace with a fast-moving organization
- Availability to participate in calls across multiple international time zones
- Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless
- Ability and willingness to travel up to 30%
The anticipated salary range for candidates for this role will be $250,000-$270,000 per 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