Define 3y spending plans and hold quarterly financial updates. 3. Strategic CMO/CDMO Oversight ... Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and ...
Define 3y spending plans and hold quarterly financial updates. 3. Strategic CMO/CDMO Oversight ... Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and ...
Senior Director / Director - CMC/GMP Quality Assurance
Palo Alto, CA ยท On-site
$235K - $285K/yr
The GMP QA candidate will report to the Chief Technical Officer, Chemistry, Manufacturing and Controls, Regulatory CMC, and Quality Assurance. The GMP QA FTE candidate will support and work with ...
Senior Director / Director - CMC/GMP Quality Assurance
Palo Alto, CA ยท On-site
$235K - $285K/yr
The GMP QA candidate will report to the Chief Technical Officer, Chemistry, Manufacturing and Controls, Regulatory CMC, and Quality Assurance. The GMP QA FTE candidate will support and work with ...
The GMP QA candidate will report to the Chief Technical Officer, Chemistry, Manufacturing and Controls, Regulatory CMC, and Quality Assurance. The GMP QA FTE candidate will support and work with ...
The GMP QA candidate will report to the Chief Technical Officer, Chemistry, Manufacturing and Controls, Regulatory CMC, and Quality Assurance. The GMP QA FTE candidate will support and work with ...
Senior Director, Regulatory Affairs CMC - Biologics
Boston, MA ยท On-site
$163K - $215K/yr
The Senior Director, Regulatory Affairs CMC - Biologics provides senior-level scientific and ... new CMO site qualification, and regulatory filing strategies for site-to-site manufacturing ...
Senior Director, Regulatory Affairs CMC - Biologics
Boston, MA ยท On-site
$163K - $215K/yr
The Senior Director, Regulatory Affairs CMC - Biologics provides senior-level scientific and ... new CMO site qualification, and regulatory filing strategies for site-to-site manufacturing ...
Define 3y spending plans and hold quarterly financial updates. 3. Strategic CMO/CDMO Oversight ... Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and ...
Quick apply
Define 3y spending plans and hold quarterly financial updates. 3. Strategic CMO/CDMO Oversight ... Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and ...
Define 3y spending plans and hold quarterly financial updates. 3. Strategic CMO/CDMO Oversight ... Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and ...
Define 3y spending plans and hold quarterly financial updates. 3. Strategic CMO/CDMO Oversight ... Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA ยท Hybrid
$163K - $215K/yr
Oversee regulatory aspects of small molecule technology transfer activities, including new CMO ... Tracks CMC regulatory deliverables and submission timelines across all small molecule programs ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA ยท Hybrid
$163K - $215K/yr
Oversee regulatory aspects of small molecule technology transfer activities, including new CMO ... Tracks CMC regulatory deliverables and submission timelines across all small molecule programs ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA ยท On-site
$163K - $215K/yr
Oversee regulatory aspects of small molecule technology transfer activities, including new CMO ... Tracks CMC regulatory deliverables and submission timelines across all small molecule programs ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA ยท On-site
$163K - $215K/yr
Oversee regulatory aspects of small molecule technology transfer activities, including new CMO ... Tracks CMC regulatory deliverables and submission timelines across all small molecule programs ...
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Interacts and communicates with CMC and CMO to assure expectations are established, agreed to, and achieved * Supports the establishment, preparation, and communication of GMP quality metrics.
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Interacts and communicates with CMC and CMO to assure expectations are established, agreed to, and achieved * Supports the establishment, preparation, and communication of GMP quality metrics.
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Interacts and communicates with CMC and CMO to assure expectations are established, agreed to, and achieved * Supports the establishment, preparation, and communication of GMP quality metrics.
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Interacts and communicates with CMC and CMO to assure expectations are established, agreed to, and achieved * Supports the establishment, preparation, and communication of GMP quality metrics.
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA ยท On-site
$163K - $215K/yr
Oversee regulatory aspects of small molecule technology transfer activities, including new CMO ... Tracks CMC regulatory deliverables and submission timelines across all small molecule programs ...
Senior Director, Regulatory Affairs CMC - Small Molecule
Boston, MA ยท On-site
$163K - $215K/yr
Oversee regulatory aspects of small molecule technology transfer activities, including new CMO ... Tracks CMC regulatory deliverables and submission timelines across all small molecule programs ...
CMC is in a significant period of physical growth, with the funding and support of the Board of ... Reporting to the Executive Vice President and Chief Operating Officer (EVP/COO), the Associate Vice ...
CMC is in a significant period of physical growth, with the funding and support of the Board of ... Reporting to the Executive Vice President and Chief Operating Officer (EVP/COO), the Associate Vice ...
Regional Development Officer Primary ResponsibilityReporting to the assigned Campus Vice President ... This position will work in tandem with CMC and CMC Foundation leadership in identifying and ...
Regional Development Officer Primary ResponsibilityReporting to the assigned Campus Vice President ... This position will work in tandem with CMC and CMC Foundation leadership in identifying and ...
Principal Scientist, CMC Analytical Development - Commercial Products
South San Francisco, CA ยท On-site
Provide technical analytical review and approval of CMO manufacturing documents for routine ... Provide analytical/CMC technical expertise in response to health authority questions from ...
Principal Scientist, CMC Analytical Development - Commercial Products
South San Francisco, CA ยท On-site
Provide technical analytical review and approval of CMO manufacturing documents for routine ... Provide analytical/CMC technical expertise in response to health authority questions from ...
Public Safety Officer 3rd Shift
Cincinnati, OH ยท On-site
$17/hr
Officers will patrol inside the Museums and exhibits, the outside perimeter of the building, and CMC grounds. Officers will monitor video surveillance, alarm systems, and access control systems.
Public Safety Officer 3rd Shift
Cincinnati, OH ยท On-site
$17/hr
Officers will patrol inside the Museums and exhibits, the outside perimeter of the building, and CMC grounds. Officers will monitor video surveillance, alarm systems, and access control systems.
Public Safety Officer 3rd Shift
Cincinnati, OH ยท On-site
$17/hr
Officers will patrol inside the Museums and exhibits, the outside perimeter of the building, and CMC grounds. Officers will monitor video surveillance, alarm systems, and access control systems.
Public Safety Officer 3rd Shift
Cincinnati, OH ยท On-site
$17/hr
Officers will patrol inside the Museums and exhibits, the outside perimeter of the building, and CMC grounds. Officers will monitor video surveillance, alarm systems, and access control systems.
Principal Scientist, CMC Analytical Development - Commercial Products
South San Francisco, CA ยท On-site
Monitor ongoing method and process performance trends at the CMO to proactively identify risks to ... Coordinate with Regulatory Affairs, CMC, and QA to align method transfer timelines with global ...
Principal Scientist, CMC Analytical Development - Commercial Products
South San Francisco, CA ยท On-site
Monitor ongoing method and process performance trends at the CMO to proactively identify risks to ... Coordinate with Regulatory Affairs, CMC, and QA to align method transfer timelines with global ...
Associate Director, CMC Technology Delivery Information Technology Posted 8 hours ago
Cambridge, MA ยท On-site
... (CMO), Software and Services partners, and Internal IT organization to develop data products ... of CMC applications - from strategy and design through deployment, sustainment, upgrades ...
Associate Director, CMC Technology Delivery Information Technology Posted 8 hours ago
Cambridge, MA ยท On-site
... (CMO), Software and Services partners, and Internal IT organization to develop data products ... of CMC applications - from strategy and design through deployment, sustainment, upgrades ...
Preconstruction Executive
Houston, TX ยท On-site
At CMC Development & Construction, working together onDeveloping Tomorrowis our motto. Founded in 2016, CMC is a full-service General Contractor firm which provides services such as construction ...
Preconstruction Executive
Houston, TX ยท On-site
At CMC Development & Construction, working together onDeveloping Tomorrowis our motto. Founded in 2016, CMC is a full-service General Contractor firm which provides services such as construction ...
Security Officer
Conway, SC ยท On-site
$14.75 - $17.50/hr
... CMC). Qualifications: Education: * High school diploma or equivalent (or ten (10) years of Security ... Officer required. Duties & Responsibilities: * Upon request the SO will collect patient valuables ...
Security Officer
Conway, SC ยท On-site
$14.75 - $17.50/hr
... CMC). Qualifications: Education: * High school diploma or equivalent (or ten (10) years of Security ... Officer required. Duties & Responsibilities: * Upon request the SO will collect patient valuables ...
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Associate Director, CMC Project Management
South San Francisco, CA โข On-site
Full-time
Re-posted 10 days ago
Job description
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.
This role requires a leader with strong business acumen to define and execute business processes that drive complex programs through global registration and commercialization. This role will play a pivotal part in bringing innovative therapies to patients by ensuring that CMC development, manufacturing, and commercialization are executed with excellence, speed, and financial discipline.
This individual will also oversee project management including timelines, budgets, invoices, reports and documentation, and may assist with regulatory filings. This position reports to Senior Director, CMC Program Management and is responsible for the following:
1. End-to-End CMC Leadership & Cross-Functional Integration
- Create and execute against integrated cross-functional project plans, leading the integrated CMC strategy.
- Translate program strategy into cohesive development, manufacturing, and supply plans with clear milestones and deliverables.
- Drive cross-functional alignment in close partnership with Clinical Development, Regulatory Affairs, Quality, Supply Chain, Commercial, and Finance teams.
- Guide and lead project performance, risk and financial management, and issues resolution for functional groups.
- Provide direction on requirements to meet internal and external stakeholders' expectations.
- Ensure CMC activities are executed in lockstep with clinical timelines, regulatory milestones, and commercial launch plans.
- Serve as the CMC representative on program governance teams, influencing key decisions and trade-offs across functions.
2. Budget Planning & Financial Stewardship
- Develop and manage comprehensive CMC budgets, including development, manufacturing, and supply chain costs.
- Drive financial planning, forecasting, and scenario modeling to support program and portfolio decisions.
- Identify and implement cost optimization strategies without compromising quality, timelines, or regulatory compliance.
- Partner with Finance to ensure transparency, accountability, and disciplined capital allocation.
- Evaluate investment trade-offs and provide data-driven recommendations to senior leadership.
- Define 3y spending plans and hold quarterly financial updates.
3. Strategic CMO/CDMO Oversight & External Partnerships
- Working with functional leads (Drug Substance, Drug Product, and Analytical Department Heads), execute a robust external manufacturing strategy, including selection, onboarding, and management of CMOs/CDMOs.
- Establish CDMO governance systems in conjunction with QA leadership such as performance metrics, and KPIs.
- Ensure accountability for delivery, quality, cost, and timelines.
- Proactively identify and mitigate risks across the external network, including capacity, quality, and supply continuity risks.
- Drive strong, collaborative partnerships while maintaining rigorous oversight and escalation processes when needed.
4. Program Leadership & Governance
- Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and quality objectives.
- Provide clear, concise communication and executive-level updates on risks, progress, and mitigation strategies.
- Build alignment across stakeholders and drive decisive, forward-looking decision-making.
Education & Experience
- Advanced degree (PhD, MS, or equivalent) in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related field preferred.
- 9+ years of experience in biopharma CMC development, with increasing leadership responsibility.
- Demonstrated success leading programs through commercialization including NDA filing and launch.
Core Capabilities
- Deep expertise in CMC development, manufacturing, and regulatory requirements.
- Proven ability to lead highly cross-functional, matrixed teams.
- Strong track record of budget ownership and financial decision-making.
- Extensive experience managing CMOs/CDMOs at a strategic level, including performance governance.
- Ability to balance technical rigor with business and commercial considerations.
- Exceptional communication, influence, and leadership skills.
Leadership Profile
- Strategic thinker with strong execution discipline
- Comfortable navigating ambiguity and complexity
- Data-driven, with strong business and financial acumen
- Collaborative, but decisive and accountable
- High ownership mindset with a focus on outcomes
The anticipated salary range for Associate Director level candidates who will work on-site at our South San Francisco location is between $210,000-$240,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.ย This position is not eligible for H-1B visa sponsorship.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
About ORIC Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1 - 10 Employees
Headquarters location
South San Francisco, CA, US
Year founded
2014