The Role
The Sr. CMC Project Manager manages CMC documentation, oversees project status, ensures cross-functional collaboration, and tracks outsourced activities, requiring strong organizational skills and biotech experience.
Summary Generated by Built In
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!
We are seeking a Sr. CMC Project Manager to join the Technical Operations Program & Strategy team at Apogee. This role is responsible for handling all CMC related documentation, managing the internal SharePoint site, migration of Tech Ops documents to Veeva Quality System, as well as provide Project Management support for one or more 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 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
- Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint
- Maintain and communicate a current overview of Tech Ops documentation status and issues, including weekly dashboards to present to the upper management
- Responsible for migration of relevant Tech Ops documentation into the Veeva Quality System
- Work with various Tech Ops teams to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
- Provide Project Management support for one or more 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
- Responsible for purchase order initiation in NetSuite, review and approval of vendor accruals and invoices
- Responsible for tracking all outsourced activities
Ideal Candidate
- Bachelor’s degree in science
- 5+ years of experience in biotech or pharmaceutical industry with 3+ years of biologics development and manufacturing experience required
- 2+ years of Technical Operations/CMC experience
- Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph 1 to Ph 3)
- Experience with Process Characterization and PPQ is a plus
- Good technical knowledge of CMC development (Upstream, Downstream, Analytical), Supply Chain, CMC Regulatory Affairs, Quality, GMP requirements
- Extensive knowledge of Smartsheet and Microsoft Timeline a must
- Veeva experience is highly desired
- 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
- Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. Will require travel to the Apogee lab in Boston, MA up to one week per year
The anticipated salary range for candidates for this role will be $160,000 - $175,000 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
- We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
- 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
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Top Skills
Microsoft Timeline
NetSuite
Sharepoint
Smartsheet
Veeva Quality System
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders
