Associate Director, CMC Project Management

Location
Redwood City, CA
Posted
May 06, 2022
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.

The Position
Bolt Biotherapeutics is a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems. Our vibrant culture is defined by our relentless pursuit of innovative therapies and data-driven decision making. We are a community of fearless innovators who are rigorous and honest in our research, while remaining committed to listening to new ideas with open minds.

At Bolt, we appreciate our employees and show our appreciation by providing autonomy and respecting individualism in all of its forms. Located in the San Francisco Bay Area, Bolt is seeking employees who are passionate about bringing novel and more effective therapies to cancer patients.

Reporting to the SVP of Pharmaceutical Operations, Bolt Biotherapeutics is seeking an experienced CMC Project Manager supporting one or more of our cross-functional CMC teams. This role is critical in ensuring stage-appropriate CMC development, coordinating the development, manufacture and characterization of new biotherapeutic candidates and laying the groundwork for future expansion of this critical function.

Key Responsibilities
• Develop and maintain an integrated project plan for each of the CMC programs. Adjust the plan according to updates from internal team members and external CDMOs/vendors
• Provide project management support for external CDMO and vendor activities. Assist in developing strategies, pivoting plans and proactively managing risk while maintaining team and company goals
• Identify and document program risks and actively play a role in developing solutions while communicating updates to the appropriate team members
• With CMC lead, manage CMC team meetings including development of agendas, facilitating and documenting meeting discussions, following up on action items, and updating the integrated project plans as needed
• Facilitate sub-team discussions and document the decisions and outcomes in an appropriate manner to improve efficiency within the team
• Create and maintain CMC project budgets and forecast consistent with the project plan and projected clinical demand
• Facilitate effective, accurate, and timely communication across all internal and external teams, including development and maintenance of trackers and status reporting tools
• Recognize when cross functional discussions and alignment are required. E.g. Regulatory updates, legal buy-in, finance approvals, etc.
• Assist in preparing CMC status updates for the program Core team as well as the company leadership team
• Develop and implement tools, templates, and infrastructure to maximize team and company efficiency

Job Requirements
• Bachelor's Degree in engineering or science with 10+ years of multi-disciplinary CMC experience in the biotech/pharmaceutical industry. 4+ years direct project management experience in a development and/or manufacturing
• Strong knowledge of project management techniques and concepts as they apply to the drug development and pharmaceutical industry
• Outstanding written and verbal communication skills
• Demonstrated ability to lead teams in a matrix management environment - ability to direct, collaborate and influence with logic, rationale and experience; comfortable with informal structure, dynamics and culture to get things done.
• Proficient in relevant software: MS Project, Smartsheet, Excel, PowerPoint, Word, etc.
• Exceptional project management skills:
o Tasks, timelines and opportunities for risk-based plan decisions
o Proactive project management and ability to rapidly address unforeseen issues
o Budget development and financial planning
o Experience working in collaborations with third parties
o Ability to capture technical discussion in the form of meeting minutes, decision points and action items. Organization skills to maintain presentations, distribute meeting minutes, and close out open items in a timely fashion.
• Strong interpersonal skills and ability to strategically adjust approach to manage diverse personalities and working styles
• Ability to drive problem solving, decision making, and issue resolution
• Unquestionable ethics and integrity
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.