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Associate Director, CMC Operations and Project Management

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 an Associate Director, CMC Operations and Project Management to join the Technical Operations team at Apogee. This role will be responsible for handling all aspects of the external DS or DP CDMO relationship for one CMC Program including, but not limited to: meetings, timelines, tech transfer, DS/DP manufacturing, all related documentation via managing the exchange of information via internal and external SharePoint sites, , as well as provide Project Management support for CMC Programs. This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your CMC Operations and Project Management expertise to deliver innovative medicine to the patients, enjoy the fast-paced environment, and thrive in a culture of growth and camaraderie – this role is for you. 

 

Key Responsibilities

  • Manage all operational and project management aspects of the external DS or DP CDMO relationship
  • Work with Tech Ops team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
  • Provide Project Management support for CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops
  • Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track
  • Submit purchase orders in NetSuite, review and approve vendor revenue recognition, accruals, and invoices
  • Assist with tracking outsourced activities for other Tech Ops groups as needed

Ideal Candidate

  • Bachelor’s degree in science
  • 10+ years of experience in biotech or pharmaceutical industry with 5-8 years of Biologics development and manufacturing experience
  • 5+ years of Technical Operations/CMC Project Management experience
  • Experience working with clinical stage candidates across all phases of Clinical Development (e.g., PhI to PhIII). Experience with PhIII to Commercial, such as DS or DP Process Characterization and PPQ is a must
  • Good technical knowledge of DS/DP Process development, Analytical, Regulatory, Quality, GMP requirements, and device
  • High level of expertise of Smartsheet, Microsoft Project, OnePager, and Office Timeline
  • Assertive and proactive
  • Highly organized with meticulous attention to detail
  • Ability to multi-task and keep pace with a fast-moving organization
  • Ability 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 15% to company All Hands Meetings, and the Apogee lab in Boston

The anticipated salary range for candidates for this role will be $175,000 - $190,000/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

 

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