Associate Director, Technical Operations Project Management
Role Summary
We are seeking an Associate Director, Technical Operations Project Management to join the Technical Operations team at Apogee. This role will be responsible for handling all Project Management aspects of the external Drug Substance CDMO relationships for one of our CMC Programs including, but not limited to: meetings, timelines, drug Substance tech transfer and manufacturing related documentation via managing the exchange of information via internal and external SharePoint sites. This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your previous drug substance 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 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
- 8+ years of experience in biotech or pharmaceutical industry with 3-5 years of Biologics development and manufacturing experience
- 5+ years of Technical Operations/ Project Management experience
- Experience working with clinical stage candidates across all phases of Clinical Development (e.g., PhI to PhIII).
- Experience with Late Stage (Process Characterization and PPQ) is a plus.
- Good technical knowledge of DS, Process development, Analytical, Regulatory, Quality, GMP requirements.
- High level of expertise of Smartsheet, Microsoft Project, One Pager, 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. Some international travel may be required.
What We Offer
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and E
- 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
The anticipated salary range for candidates for this role will be $165,000-$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.
- 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
Apply for this job
*
indicates a required field