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Cmc In Biotech Jobs in Oregon (NOW HIRING)

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This role provides cross-functional leadership across clinical, regulatory, CMC, quality ... Master's or PhD in medical, pharma or biotech field strongly preferred; 12+ years in pharma/biotech ...

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... biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.

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... Clinical, Quality, CMC, Medical Writing) * Oversee project team delivery of the marketing ... Strong understanding of drug development and how biotech functions integrate * Experience in ...

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... biotech, or life sciences * 5+ years of experience in Regulatory Affairs * Strong background in ... Experience working on cross-functional teams (Clinical, CMC, Quality, etc.) * Solid understanding ...

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This role is uniquely designed for a physician leader who thrives in a high-growth biotechnology ... Affairs, CMC, Commercial, and Corporate Development teams to ensure coordinated execution of ...

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Provide senior-level guidance to manufacturing, project, and CMC teams on PQS requirements and ... pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in ...

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Partner with Regulatory Affairs, CMC, Clinical Operations, Manufacturing, Supply Chain, and ... pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in ...

Cmc In Biotech information

What is a CMC in biotech position?

A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP regulations, process development, and analytical techniques.

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that manufacturing processes meet quality standards and regulatory requirements, often working with laboratory analysis, process validation, and compliance documentation.

What is the CMC department in biotech?

The CMC (Chemistry, Manufacturing, and Controls) department in biotech is responsible for developing, manufacturing, and ensuring the quality of biopharmaceutical products. It involves activities such as process development, validation, regulatory documentation, and quality control to ensure products meet safety and efficacy standards.
What are popular job titles related to Cmc In Biotech jobs in Oregon? For Cmc In Biotech jobs in Oregon, the most frequently searched job titles are:
What cities in Oregon are hiring for Cmc In Biotech jobs? Cities in Oregon with the most Cmc In Biotech job openings:
Infographic showing various Cmc In Biotech job openings in Oregon as of July 2026, with employment types broken down into 2% As Needed, 89% Full Time, 3% Part Time, 1% Temporary, and 5% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution.

Sr Director, Product Development Lead - 591

Telix Pharmaceuticals (AMER)

OR • On-site

Full-time

Re-posted 3 days ago


Job description

See Yourself at Telix

The Sr Director, Product Development Lead is entrusted with owning and leading the global development of late-stage radiopharmaceutical compounds for therapeutic oncology indications. This role provides cross-functional leadership across clinical, regulatory, CMC, quality, manufacturing/supply chain, and commercial, and drives governance, decision-making, and risk management to deliver program milestones and support regulatory interactions and approvals. This role may include direct people management of one or more Project managers. As a strategic thinker and clear communicator, the role requires a hands-on approach to aligning stakeholders, maintaining an execution-ready integrated plan, and presenting program status, risks, and recommendations to senior leadership.

Key Accountabilities:

  • Development Leadership: Lead the Global Program Leadership Team (GPLT) and hold accountability for cross-functional commitments across CMC, Clinical, and Regulatory. Set and communicate GPLT program objectives in alignment with the Tx BU objective cascade model, ensuring clarity on shared program outcomes vs. functional objectives. Develop and maintain the Global Development Plan (GDP) and Target Product Profile (TPP), ensuring these remain current and drive aligned decision-making across the matrix team.
  • Strategic Direction: Showcase courage in strategic thinking, guiding matrixed teams through complex decision-making and risk management processes. 
  • Cross-functional Collaboration: Foster a collaborative spirit, working seamlessly with teams spanning clinical, non-clinical, regulatory affairs, quality, manufacturing and supply chain, commercial, medical affairs and program management to formulate plans that achieve program milestones and objectives. 
  • Program Governance & Change Management: Drive integrated cross-functional planning and confirm readiness for key milestones and inflection points; ensure scope, timeline, and budget impacts are assessed and elevated appropriately for leadership review (e.g., Product Management Committee) and that decisions are documented and communicated.
  • Risk Ownership & Communication: Identify, assign ownership of, and actively manage program risks/issues; communicate risks, mitigations, and decisions clearly to stakeholders and leadership.
  • Budget Planning & Forecasting: Lead program-level budget planning and forecasting in partnership with Finance and functional leads; monitor spend vs. plan, surface variances, and drive timely re-forecasting and trade-off recommendations to support portfolio decisions.
  • Regulatory Pathway Design: Partner with Clinical and Regulatory Affairs to craft the ideal development pathway for approval, aiming to meet product attributes and commercial objectives. 
  • Regulatory Interactions & Communication Alignment: Lead cross-functional preparation for key health authority interactions (e.g., FDA Type B), ensuring consistent internal communication, clear objectives, aligned messaging, and timely delivery of high-quality briefing materials and responses.
  • Executive-Ready Program Reporting: Maintain clear, decision-focused reporting (dashboards, milestone tracking, red/amber/green risks) and ensure critical risks are visible to appropriate leadership teams with recommended actions and owners.
  • Development Planning: Create and execute comprehensive product development plans and data packages, paving the way for informed go/no-go decisions and continuous progression towards product approval. 
  • CMC/Supply & Vendor (CDMO) Alignment: Partner with Technical Operations, Quality, and external vendors to ensure manufacturing readiness, GMP compliance, and supply continuity; proactively identify constraints and develop mitigation plans that protect clinical execution and regulatory commitments.
  • Stakeholder Engagement: Engage subject matter experts and thought leaders, both within and outside the organization, fostering rich scientific dialogue, extracting insights, and refining development plans and strategies. 
  • Global Study Execution & Enrollment Enablement: Collaborate with Clinical Operations and regional teams to anticipate recruitment risks (including competing trials), support site activation strategy, and drive actions that protect enrollment and global data consistency.
  • Inclusive Leadership & Communication: Foster an inclusive, respectful team culture, including use of inclusive language in communications and reinforcement of constructive cross-functional collaboration.

Education and Experience:

  • Master's or PhD in medical, pharma or biotech field strongly preferred; 12+ years in pharma/biotech required. 
  • Minimum of 5+ years leading cross-functional product teams within the pharma/biotech domain.  
  • Prior experience in oncology development and/or radiopharmaceuticals will be a distinct advantage. 
  • Experience in clinical Phase 2, Phase 3 and through approval required, specifically in the therapeutic area assigned. 
  • Demonstrated ability to think strategically, communicate effectively, and collaborate in a matrixed team environment. 
  • Direct people management experience is considered an advantage.

Key Capabilities

  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills