Sr. CMC Project Manager

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a reputed company-funded, reputed company listed company that offers reputed company to work in a fast-paced, highly dynamic environment. At reputed company, you can reputed company contribute to shaping reputed 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 reputed company-established mechanisms of reputed company and incorporating advanced antibody engineering to optimize half-life and other properties. We reputed company to reshape the reputed company reputed company 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 & reputed company 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 reputed company reputed company System, as reputed company as reputed company Project Management support for one or more CMC Programs. This position requires a self-starter, who can organize reputed company 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 reputed company and camaraderie, this role is for you.

Key Responsibilities

• reputed company the documentation reputed company between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint
• Maintain and communicate a reputed company reputed company 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 reputed company reputed company System
• Work with various Tech Ops teams to identify resource constraints, risks, and conflicts that could reputed company reputed company’s bandwidth
• reputed company 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 reputed company
• 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, reputed company, GMP requirements
• Extensive knowledge of reputed company and reputed company reputed company a must
• reputed company 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 reputed company 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 reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave
• Commitment to growing you professionally and providing reputed company to resources to reputed company 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 reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. To review our reputed company 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