Sr. CMC Project Manager

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a well-funded, reputed company listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At reputed company, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. reputed company, Inc. is a biotechnology company seeking to reputed company 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 reputed company standard of care for inflammatory and immune diseases because we reputed company 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, reputed company reading! We are seeking a Sr. CMC Project Manager to join the Technical Operations Program & Strategy team at reputed company. This role is responsible for handling reputed company CMC reputed company 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 reputed company in a culture of growth and camaraderie, this role is for you.

Key Responsibilities

• reputed company the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint
• Maintain and communicate a reputed company 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 reputed company, review and approval of vendor accruals and invoices
• Responsible for tracking reputed company 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 reputed company 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, reputed company, Analytical), Supply Chain, CMC Regulatory Affairs, Quality, GMP requirements
• Extensive knowledge of reputed company and reputed company Timeline a must
• Veeva experience is highly desired
• Highly organized with meticulous attention to detail
• Ability to multi-task and reputed company pace with a fast-moving organization
• Ability to participate in calls across multiple international time zones
• Successfully exhibit reputed company’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
• Position requires up to 20% travel including mandatory in-person attendance at reputed company Hands meetings typically held twice per year. Will require travel to the reputed company 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. reputed company 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 reputed company 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
• reputed company offers regular reputed company 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, reputed company participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, 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 reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply To this Job