Knowledge of cGMP requirements and ICH guidelines related to CMC small molecule drug-substance development and manufacturing. * Track record of working closely with cross-functional teams in a ...
Knowledge of cGMP requirements and ICH guidelines related to CMC small molecule drug-substance development and manufacturing. * Track record of working closely with cross-functional teams in a ...
Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates. * Experience with regulatory CMC strategy development and health authority ...
Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates. * Experience with regulatory CMC strategy development and health authority ...
Associate Director / Director, Regulatory Affairs CMC
Bothell, WA · On-site
$177K - $238K/yr
Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates. * Experience with regulatory CMC strategy development and health authority ...
Associate Director / Director, Regulatory Affairs CMC
Bothell, WA · On-site
$177K - $238K/yr
Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates. * Experience with regulatory CMC strategy development and health authority ...
Knowledge of cGMP requirements and ICH guidelines related to CMC small molecule drug-substance development and manufacturing. * Track record of working closely with cross-functional teams in a ...
Knowledge of cGMP requirements and ICH guidelines related to CMC small molecule drug-substance development and manufacturing. * Track record of working closely with cross-functional teams in a ...
Director, Quality Control
Seattle, WA · On-site
... class small-molecule and protein therapeutics for large-market and orphan indications, with ... CMC teams * Partner with internal and external stakeholders to transfer, qualify and validate ...
Director, Quality Control
Seattle, WA · On-site
... class small-molecule and protein therapeutics for large-market and orphan indications, with ... CMC teams * Partner with internal and external stakeholders to transfer, qualify and validate ...
Director, Quality Control
Seattle, WA · On-site
... class small-molecule and protein therapeutics for large-market and orphan indications, with ... CMC teams * Partner with internal and external stakeholders to transfer, qualify and validate ...
Director, Quality Control
Seattle, WA · On-site
... class small-molecule and protein therapeutics for large-market and orphan indications, with ... CMC teams * Partner with internal and external stakeholders to transfer, qualify and validate ...
Director, Quality Operations
Bothell, WA · On-site
Experience with small molecules and biologics is required. Responsibilities Quality Operations ... Participate in Quality Management Review meetings, as needed. * Assist in updating CMC sections of ...
Director, Quality Operations
Bothell, WA · On-site
Experience with small molecules and biologics is required. Responsibilities Quality Operations ... Participate in Quality Management Review meetings, as needed. * Assist in updating CMC sections of ...
Director, Quality Operations
Bothell, WA · On-site
Experience with small molecules and biologics is required. Responsibilities Quality Operations ... Participate in Quality Management Review meetings, as needed. * Assist in updating CMC sections of ...
Director, Quality Operations
Bothell, WA · On-site
Experience with small molecules and biologics is required. Responsibilities Quality Operations ... Participate in Quality Management Review meetings, as needed. * Assist in updating CMC sections of ...
Research Associate I
Seattle, WA · On-site
... our CMC team. The Research Associate, Analytical Sciences will support drug substance and drug ... small-molecule therapeutics for both large-market and orphan indications, with a focus on ...
Research Associate I
Seattle, WA · On-site
... our CMC team. The Research Associate, Analytical Sciences will support drug substance and drug ... small-molecule therapeutics for both large-market and orphan indications, with a focus on ...
Research Associate I
Seattle, WA · On-site
... our CMC team. The Research Associate, Analytical Sciences will support drug substance and drug ... small-molecule therapeutics for both large-market and orphan indications, with a focus on ...
Research Associate I
Seattle, WA · On-site
... our CMC team. The Research Associate, Analytical Sciences will support drug substance and drug ... small-molecule therapeutics for both large-market and orphan indications, with a focus on ...
... CMC, Discovery, Quality Assurance, Regulatory Affairs, and corporate objectives. The scope of this ... class small-molecule and protein therapeutics for large-market and orphan indications, with ...
... CMC, Discovery, Quality Assurance, Regulatory Affairs, and corporate objectives. The scope of this ... class small-molecule and protein therapeutics for large-market and orphan indications, with ...
... CMC, Discovery, Quality Assurance, Regulatory Affairs, and corporate objectives. The scope of this ... class small-molecule and protein therapeutics for large-market and orphan indications, with ...
... CMC, Discovery, Quality Assurance, Regulatory Affairs, and corporate objectives. The scope of this ... class small-molecule and protein therapeutics for large-market and orphan indications, with ...
Director, Regulatory Affairs, Strategy
Bothell, WA · On-site
$220K - $260K/yr
Our lead drug candidates, lasofoxifene and ATH-1105, are novel, small molecule therapies with the ... CMC, and program timelines. Own the regulatory critical path and escalate risks with recommended ...
Director, Regulatory Affairs, Strategy
Bothell, WA · On-site
$220K - $260K/yr
Our lead drug candidates, lasofoxifene and ATH-1105, are novel, small molecule therapies with the ... CMC, and program timelines. Own the regulatory critical path and escalate risks with recommended ...
Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and ... small molecule linker-payloads and antibody intermediate materials. Expected expertise in relevant ...
Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and ... small molecule linker-payloads and antibody intermediate materials. Expected expertise in relevant ...
Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and ... small molecule linker-payloads and antibody intermediate materials. Expected expertise in relevant ...
Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and ... small molecule linker-payloads and antibody intermediate materials. Expected expertise in relevant ...
Cmc Small Molecules information
See Bothell, WA salary details
$16.66 - $19.76
25% of jobs
$19.80 is the 25th percentile. Wages below this are outliers.
$19.76 - $22.87
25% of jobs
The median wage is $22.99 / hr.
$22.87 - $25.97
13% of jobs
$25.97 - $29.07
9% of jobs
$29.07 - $32.17
3% of jobs
$32.95 is the 75th percentile. Wages above this are outliers.
$32.17 - $35.28
3% of jobs
$35.28 - $38.38
9% of jobs
$38.38 - $41.48
3% of jobs
$41.48 - $44.58
2% of jobs
$44.58 - $47.69
6% of jobs
$47.69 - $50.79
2% of jobs
$16
$29
$50
How much do cmc small molecules jobs pay per hour?
What is CMC Small Molecules?
What skills and qualifications are needed to thrive as a CMC Small Molecules professional?
What are the main challenges faced by CMC Small Molecules professionals during drug development projects?
What is the difference between Cmc Small Molecules vs CMC Formulation Scientist?
| Aspect | Cmc Small Molecules | CMC Formulation Scientist |
|---|---|---|
| Required Credentials | Bachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; GMP knowledge | Bachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields; formulation expertise |
| Work Environment | Laboratories, manufacturing facilities, R&D settings | Laboratories, formulation development labs, production environments |
| Employer & Industry Usage | Pharmaceutical companies, biotech firms, contract research organizations | Pharmaceutical companies, biotech firms, contract manufacturing organizations |
While both roles involve working within the pharmaceutical industry and require similar educational backgrounds, Cmc Small Molecules focuses on the development and manufacturing of small molecule drugs, emphasizing chemistry and process development. In contrast, CMC Formulation Scientists specialize in creating drug formulations, ensuring stability and delivery. Both roles are essential in bringing new drugs to market but differ in their specific focus areas and daily responsibilities.
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Full-time
Posted 4 days ago
Job description
Position Overview
We are seeking an experienced Principal Scientist, Chemical Development to join our dynamic team to help advance our pipeline of innovative targeted cancer therapies. The successful candidate will apply their expertise in small molecule process development and manufacturing to support a variety of modalities in the Immunome pipeline with a focus on small molecule linker-payload targets for ADCs. This person will play a key role in leading challenging drug candidate process development programs, enabling treatment of patients in need.
Responsibilities
Leadership
- Provide technical leadership as a key member of the chemical development team while maintaining alignment with the company's goals and objectives.
- Function as the technical lead on at least one program while also functioning as an individual technical contributor.
- Provide guidance and leadership to external partners working towards the successful advancement of antibody drug conjugates, radiopharmaceuticals, and other lead programs.
- Support programs at the bench as an individual contributor as needed.
Technical Expertise
- Leverage knowledge and experience in the development and execution of robust and scalable small molecule synthetic processes.
- Devise and evaluate alternative routes of synthesis with the aim of developing robust and efficient routes to APIs while reducing cost of goods (COGs) and shortening manufacturing lead times.
- Develop robust data packages for technical transfer of processes for manufacturing partners at external CMOs.
- Maintain knowledge of the current state of the art in synthetic methods utilized for the construction of complex molecules.
- Carry out thorough analytical data collection both as an individual contributor in the lab as well as via oversight and review of data collected at our external partners.
- Contribute to authoring relevant sections of various regulatory documents (IND, IMPD, NDA, briefing books, etc.) and provide SME support for related regulatory inquiries.
Cross-Functional Collaboration
- Execute the integrated CMC regulatory strategies for pipeline programs.
- Collaborate with research, regulatory affairs, and CMC teams to ensure seamless coordination of activities.
- Provide feedback to research on synthetic routes and raw materials that are CMC friendly.
- Foster strong collaborations with internal and external stakeholders.
- Engage colleagues in discovery chemistry to provide CMC input of target molecules under evaluation for future development.
Innovation
- Stay abreast of the latest advancements in synthetic methodology as well as new technologies and methodologies to enhance our capabilities.
- Advance Immunome's intellectual property portfolio.
Quality and Compliance
- Ensure compliance with relevant regulatory guidelines and industry standards for chemical development processes.
- Uphold high-quality standards and address any compliance issues.
Qualifications
- PhD in Synthetic Organic Chemistry or similar with a minimum of 7 years of industry experience leading small molecule and/or linker-payload programs, or equivalent combination of education and experience.
- Experience as a technical lead overseeing tech transfer, process development and implementation of processes for manufacture at internal and/or external manufacturers is a plus.
- Occasional evening and/or weekend commitment.
- Ability to travel domestically and internationally (5-15%).
Knowledge and Skills
- Ability to design cost effective robust manufacturing processes for complex small molecule targets as well as troubleshoot and solve complex technical challenges quickly.
- Brings a collaborative and open-minded attitude when working with various internal and external teammates.
- Meticulous and detail-oriented scientist with the ability to operate as an individual contributor at the bench while also managing external partners.
- Proficient in generating robust and reliable analytical data utilizing various technologies in a hands-on capacity as well as evaluation of analytical data generated at external partners.
- Proficient in writing technical reports and formulating presentations
- Ability to develop cross functional relationships with discovery chemistry and other pre-clinical groups.
- Experience in leading and managing technology transfers to third party process development and manufacturing partners.
- Knowledge of cGMP requirements and ICH guidelines related to CMC small molecule drug-substance development and manufacturing.
- Track record of working closely with cross-functional teams in a biopharmaceutical or pharmaceutical environment.
- Excellent interpersonal and communication skills.
About Immunome
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
Exton, PA, US
Year founded
2006