Associate Director, CMC Project Management
mazetherapeutics
The Position Join Maze Therapeutics as our Associate Director, CMC Project Management. In this highly visible role within Technical Operations, you will drive cross-functional planning and execution across our pipeline programs while managing development and manufacturing timelines in collaboration with our CMOs. Reporting to the VP, Technical Operations, you will partner closely with CMC, Quality, and key internal stakeholders to enable program milestones, support regulatory success, and ultimately help bring potential medicines to patients. The Impact You'll Have Provide end-to-end CMC project management support across the drug development lifecycle. Lead cross-functional teams (Chemical Development, Pharmaceutical Develop ment , CMC Analytical, QA, CMC Regulatory, and Clinical Supply Chain) to plan and execute CMC activities aligned with corporate goals . Serve as the point of contact to facilitate the meeting discussions with the CMOs and follow up on the action items . Own risk management for assigned programs - establishing risk registries, identifying and mitigating risks, and escalating issues before they impact timelines or objectives . Serve as the primary CMC project management point of contact to collaborate with the Program Management team, maintaining full command of CMC scope, status, and key risks while coordinating interdependencies across workstreams. Facilitate governance and decision-making by preparing proposals, analyses, and recommendations for senior leadership review, and resolving cross-team conflicts that could impede progress. Contribute to the planning and preparation of regulatory filings (e.g., IND, IMPD, etc.) in close partnership with Regulatory CMC and other functional teams. Drive clear, consistent communication through dashboards, status reports, and meeting operations (agendas, minutes, action-item follow-up) for stakeholders ranging from project teams to senior leadership. Cultivate strong working relationships across functions and with external partners to foster a collaborative, high-performing team environment and enable timely issue resolution. Champion continuous improvement of project management processes, tools, and governance frameworks, and support program-level budget tracking and financial forecasting. Leadership Competencies Communication and Influence Communicates the reasoning behind decisions to appropriate stakeholders Promotes open communication with internal and external stakeholders Fosters healthy and respectful debate Teamwork and Collaboration Creates opportunities for team members to connect with others outside the team Manages conflict effectively between teams Openly values thoughts, opinions and contributions of employees Execution and Results Exercises astute judgement to make decisions with only the necessary amount of data Supports team members in creating their own resolutions to challenges and problems Works with others to reinforce process compliance, what good looks like, and risk mitigation Develop Others and Self Articulate what good looks like throughout Maze Pursues development activities for continuous improvement of self and team What We're Looking For Bachelor's degree in life sciences, scientific, technical, engineering, or business discipline required (or equivalent relevant experience); advanced degree preferred. Minimum of 10 years total professional experience, including at least 5 years in project management within the pharmaceutical, biotechnology, or medical device industry. At least 3 years directly managing cross-functional teams in a matrixed organization, with demonstrated success driving complex programs to completion in fast-paced environments. Working knowledge of CMC and drug development functions such as process development, analytical development, formulation, manufacturing, quality systems, supply chain, packaging, and regulatory CMC requirements. Understanding of the drug development lifecycle from Pre-IND through NDA/commercialization, including clinical development processes; experience with late-stage or commercial programs is a plus. Familiarity with GMP/GxP-regulated environments and quality management systems, ideally within small molecule modalities. Proficiency with project management and collaboration platforms (e.g., Smart-sheet, Microsoft Project, SharePoint, Microsoft Office Suite); PMP certification preferred but not required. Strong organizational, prioritization, and time-management skills, with the ability to adapt to shifting priorities and manage multiple projects simultaneously. Excellent verbal and written communication skills, with the ability to build effective relationships and influence outcomes across teams without formal authority. Ability to work both independently and collaboratively, ideally with prior exposure to start-up or growth-stage #J-18808-Ljbffr
$210k - $240k
...to patients by ensuring that CMC development, manufacturing,... ...individual will also oversee project management including timelines, budgets... ...position reports to Senior Director, CMC Program Management and... ...anticipated salary range for Associate Director level candidates who...SuggestedH1b- Associate Director, CMC Project Management About the job Associate Director, CMC Project Management Associate Director, CMC Project Management In this highly visible Technical Operations role, you will lead cross-functional planning and execution across development programs...SuggestedWork at office
- ...proud to be an equal opportunity employer and will consider all qualified applicants for employment. Position: Senior Manager/Associate Director, CMC Project Management Location: South San Francisco, CA Job Id: 370 # of Openings: 1 Senior Manager/Associate Director, CMC...SuggestedFull time
- Enigma Search in California seeks an Associate Director, CMC Project Management to lead cross-functional planning across development programs, driving CMC strategy, timelines, and manufacturing activities in partnership with external CMOs. You will collaborate with Quality...Suggested
$162.5k - $227.5k
Associate Director, CMC Project Management Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage...SuggestedFull timeFor contractorsWork at officeRemote workWork visa3 days per week$193.5k - $236.5k
...Job Description Job Description The Position Join Maze Therapeutics as our Associate Director, CMC Project Management. In this highly visible role within Technical Operations, you will drive cross-functional planning and execution across our pipeline programs while...Work at officeShift work$159k - $207k
.../Core Job Responsibilities: Organize, manage, and drive CMC strategies, plans, and deliverables for... ...point of contact for outsourced CMC projects and early-stage biotherapeutics requiring... ...with technical leaders, Program Directors, and cross-functional teams to develop...- TCG Labs‑Soleil is seeking a Senior Manager / Associate Director, Process Development to lead CMC biologics DS/DP process development and manufacturing efforts. You... ..., and external CDMOs. The role emphasizes strong project management, regulatory insight (FDA/EMA/ICH), and...
- ...Therapeutics Inc is seeking a leader to organize and manage CMC strategies, deliverables, and timelines for... ...with technical leaders, program directors, and cross-functional teams to integrate CMC deliverables into project timelines. Qualifications include a BA/BS in...
$209k - $260k
...capitalizing on the strengths of each geographic location. Position Summary Reporting to SVP Technical Operations, the Director Technical (CMC) Project Management will provide technical CMC project management support and leadership across all late‑stage development programs...$205.11k - $239.93k
...function and contractility. Cytokinetics is seeking an accomplished medicinal chemist to serve as a Associate Director, Medicinal Chemistry Project and External Operations Manager, combining hands-on scientific leadership of discovery projects with ownership of the strategy,...$171k - $223k
## Associate Director, Regulatory Project ManagerApplylocations: South San Franciscotime type: Full timeposted on: Posted 4 Days Agojob requisition id... ...trusted cross-functional partner to Regulatory Program Managers, Medical Writing, Regulatory Operations, and...Local areaShift work- ...Our client is in immediate need of a Program Manager to serve as a strategic partner to the... ...and execution across clinical, regulatory, CMC, nonclinical, and commercial functions. Develop and maintain integrated project timelines, scenario plans, and risk mitigation...Immediate start2 days per week3 days per week
- Associate Director, Recruiting The Associate Director, Recruiting is a hands... ...partner to hiring managers, bringing strong recruiting... ...such as cell therapy, ATMPs, CMC, clinical development, regulatory... ...transferable, or primarily project management experience. Help...Remote work
- ...YouTube. Job Description The Associate Director Regulatory Affairs,... ...Manufacturing and Controls (CMC) works with internal and external... ...pass approvals. Develops and manages content strategy for regulatory... ...brand teams, for assigned projects; negotiates with and influences...
$186k - $235k
...geographic location. Position Summary The Associate Director of Medical Writing will be... ...writing professional with the ability to manage multiple projects in a fast‑paced environment. The ideal... ...Biostatistics, Pharmacovigilance, Nonclinical, CMC, and Program Management) to gather...Remote work$165k - $185k
...States as part of Turner & Townsend. It specializes in project and program management for public sector organizations, with industry-leading... ...Turner & Townsend Heery is looking for an Associate Director of Project Management to join our team. The Associate...Full timeContract workLocal areaFlexible hours$150k - $170k
...cancer and autoimmune disease. Led by a management team with significant experience in cell... ...Team. This individual will serve as a key project management leader responsible for driving... ...in project management with an emphasis on CMC knowledge and the ability to support Clinical...Full timeWork at officeLocal areaRemote work- Maze Therapeutics seeks an Associate Director, CMC Project Management to drive cross‑functional planning and execution across our pipeline, coordinating development and manufacturing timelines with CMOs. You will align with CMC, Quality, and stakeholders to enable milestones...
- Structure Therapeutics is seeking a Director of Technical (CMC) Project Management to lead late‑stage CMC programs from development through commercialization. You will drive integrated plans, budgets, risk management and cross‑functional alignment with Tech Ops and CDMOs...
- Nurix Therapeutics, Inc. in Brisbane, CA, is seeking an Associate Director, Chemical Development to lead cGMP manufacturing and DS/RSM program... ...a PhD in a related field and 5+ years in pharma/biotech CMC/cGMP, with experience in scale-up, QbD, and IND/NDAs. Up to 5...
$160k - $200k
Senior Manager / Associate Director, Process Development Department: CMC Work Location: This is an on‑site position based at our corporate Headquarters in South San... ...development/manufacturing with strong CMC project management skills. In this role you will be working...Temporary workFlexible hours- Neurona Therapeutics, a neuroscience-focused cell therapy company, is seeking a Senior Manager/Associate Director, CMC Project Management to lead integrated CMC planning and execution across multiple cross-functional teams supporting clinical supply, late-stage development...
$141.5k - $268.5k
...for annual financial business processes. The Associate Director, Portfolio Insights drives high-impact strategic projects and provides broad exposure across Portfolio... ...Financial Long Range Planning (LRP). Change management & capability building: Socialize the value and...Temporary workFlexible hours$195.39k - $227.96k
...cardiac muscle dysfunction. The Associate Director, Clinical Supply Chain, will... ...chain strategies, meet project deliverables, solve business... ...distribution and inventory management of clinical supplies at clinical... ...strategies that align with CMC, Clinical Operations,...Worldwide$190k - $230k
Associate Director, Clinical Development Program Management Using living cells to treat - and sometimes even cure - cancer is... ...Team Leads, Clinical Development, CMC, Regulatory Affairs, Biometrics,... ...strategy into integrated, executable project plans. Support cross-functional...Local area$225k - $260k
...realizing a world where we make brain disorders history. As a Director, Project Management, you will serve as a strategic partner to the R&D... ...experts across Research, Development, Clinical, Regulatory, CMC, and other functions to translate strategy into actionable...Local areaWorldwideFlexible hours$229.5k - $255.87k
...script to outmatch disease. Position The Associate Director, Pharmacovigilance Operations (PVO) is... ...— and for oversight of the end-to-end management of Individual Case Safety Reports (... ...Strong analytical, organizational, and project management skills; able to manage...Temporary work- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate... ...CTAs and variations. You will also guide agency meetings, manage change controls, and mentor team members. The role...
$174k - $268k
Associate Director, Insights & Analytics About Us Kardigan is a heart health company working to... ...Affairs, Regulatory Affairs, Program Management, and Business Development teams, the Associate... ..., and disease area trends) Strong project and process management skills...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, CMC Project Management. Be the first to apply!
- remote associate product manager South San Francisco, CA
- associate director operations South San Francisco, CA
- associate director clinical data management South San Francisco, CA
- associate director clinical operations South San Francisco, CA
- associate director contracts South San Francisco, CA
- associate director South San Francisco, CA
- associate medical director South San Francisco, CA
- associate scientific director South San Francisco, CA
- associate manager South San Francisco, CA
- associate director clinical research South San Francisco, CA


