- Perform experiments in the synthesis, purification, and characterization of small molecules as a part of process investigation, quality by design (QbD) process development, and optimization
- Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, and validation protocols/reports
- Support external CDMO activities for drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization
- Assist in the generation of regulatory filings, including IND/IMPDs and NDA/MAAs
- Document development activities as source reports for regulatory filings
- Work effectively with the cross-functional CMC teams to ensure timely delivery of drug substance throughout the full drug lifecycle
- Implement best practices and drive continuous improvements in the drug substance development process through technology innovation and problem solving
- Proactively identify risks and communicate effectively to functional teams across all levels of the organization
- Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings
- Hands-on experience in working in the lab to solve process chemistry issues is highly desired
- Experience with control strategy development and capable of utilizing QbD principles to develop commercially viable manufacturing processes
- Knowledge of cGMP, ICH, and regulatory requirements
- Highly proficient oral and written communication abilities
- Excellent collaboration, problem-solving, and organizational skills
- Comfortable in a fast-paced small company environment
- Ability to travel domestically and internationally up to 25% of the time to support ongoing manufacturing activities
- PhD./MS in Organic Chemistry, Chemical Engineering, or related field
- Elevate
- Challenge
- Nurture
-
Scientist, Chemical Development
3 weeks ago
Alumis Inc. South San Francisco, United States FreelanceAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change t ...
-
Scientist, Chemical Development
1 week ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Research Development/chemical Lab Technician
2 weeks ago
Radiant company Fremont, United StatesPay rate is $35/hr · Title: R&D Specialist 1 · Location: 46409 Landing Parkway.. Fremont CA 94538 · Assignment Length: 6 months-1 year · Est Hours Per Week: 40hrs · Work Schedule + Time Zone: ~8-5pm · Temp to Hire (Y/N): TBD · **Job Description**: · Roles and Responsibilities: (J ...
-
Research Development/chemical Lab Technician
2 weeks ago
Radiant company Fremont, United StatesPay rate is $35/hr · **Job Title: R&D Specialist 1** · **Location: Fremont CA 94538** · **Assignment Length: 6 months-1 year** · Est Hours Per Week: 40hrs · Work Schedule + Time Zone: ~8-5pm · Temp to Hire (Y/N)? TBD · **Roles and Responsibilities: (JD)** · - Maintain a safe R&D ...
-
Chemical Development Intern
1 week ago
Nurix Therapeutics San Francisco, United StatesPosition: Intern · Duration: 10 weeks · Project Description: Process optimization and impurities characterization of small molecule API manufacture · Manager Name: Chih-Tsung (Tom) Lin · Department: Chemical Development, CMC · Internship Job Description · We are seeking a motiva ...
-
Cytokinetics, Incorporated South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
-
Cytokinetics, Incorporated South San Francisco, United StatesCytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or ...
-
Director, Chemical Development
1 week ago
Biomea Fusion, Inc. Redwood City, United StatesJob description: · We are seeking an exceptional and highly motivated individual to lead the Chemical Development team. Successful candidate will be passionate about synthetic chemistry, excited to solve complex problems in a fast-paced environment, and comfortable in the multid ...
-
Nurix Therapeutics San Francisco, United States Full timeNurix Therapeutics ) is a private biopharmaceutical company developing novel small molecule immune modulators for the treatment of cancer and autoimmune diseases. Based on the successful progress of our R&D platform, including expertise in medicinal chemistry, immune cell biology ...
-
Process Development Associate 2
2 weeks ago
corbion South San Francisco, United StatesAt Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. · **RESPONSIBILITIES**: · - Hands-on role in the setup, operation, and cleaning of bench and pilot scale equipment, with focus on downstream recovery proce ...
-
Route Service Trainee
3 weeks ago
Auto-Chlor System South San Francisco, United States**Auto-Chlor is a national service leader in the restaurant & hospitality industries. We are a people first training and development organization, committed to providing the best service to our customers.** · If you have a **positive attitude, **want to learn a new skill, and fin ...
-
Soleil Labs, LLC South San Francisco, United States**Scientist I** MOLECULAR BIOLOGY AND EXPRESSION, PROTEIN SCIENCES**: · **April 2024**: · **Department**:Technology**: · ***: · **Work Location**: Corporate Headquarters (South San Francisco)**: · ***: · **Position Summary**: · ***: · **Responsibilities**: · - Perform molecular b ...
-
Scientist, Antibody Engineering
1 week ago
Twist Bioscience South San Francisco, United StatesScientist I, Antibody Engineering · South San Francisco · We seek an outstanding, innovative, and creative Scientist to join our antibody discovery effort. This Scientist will play multiple roles within the Pharma group and will work within a team responsible for antibody discove ...
-
Lab Operations Specialist Rcmb
2 weeks ago
Recombia Biosciences, Inc. Brisbane, United StatesESSENTIAL DUTIES and RESPONSIBILITIES include, but are not limited to the following: · - General Lab Operations · - Perform certain administrative tasks to support general lab operations (maintain consumable and reagent inventory spreadsheets, mail/ship packages, organize standar ...
-
Maintenance Technician
3 weeks ago
Hines Brisbane, United StatesOverview: · When you join Hines, you will embark on a career journey fueled by vision and guided by leaders who set the standards of our industry. Our legacy is rooted in innovation and excellence, earning us a spot on Fast Company's esteemed annual list of the World's Most Innov ...
-
Food Safety
1 week ago
dnata Brisbane, United StatesOverview: · We recruit the best talent and invest in their ongoing development, through training and mentoring. We provide opportunities to work across our national network. dnata catering U.S. is looking for a **Food Safety & Quality Assurance **Coordinator **to join our **Brisb ...
-
Production Associate
1 week ago
Auto-Chlor System South San Francisco, United States**Auto-Chlor is a national service leader in the restaurant & hospitality industries. We are a people first training and development organization, committed to providing the best service to our customers.** · If you have a **positive attitude, **want to learn a new skill, and fin ...
-
Research Associate
1 week ago
Vilya, Inc. South San Francisco, United StatesVilya is a computational biotechnology company creating a novel class of medicines to precisely target disease biology. We believe computational approaches are an integral, if not foundational, component of drug discovery and development. Our platform is built on ground-breaking ...
-
Software Project Manager
5 days ago
Thermo Fisher Scientific South San Francisco, United StatesThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisti ...
-
Merck Sharp & Dohme South San Francisco, United States**Primary Responsibilities**: · - Enable discovery partner groups with advanced analytical methods · - Represent the discovery analytical research group in project teams · - Explore and develop new technologies applicable to the field of measurement science. · - Demonstrate effec ...
Scientist, Chemical Development - South San Francisco, United States - BioSpace
Description
Job DetailsAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
The Alumis team is seeking a highly motivated Scientist, in Chemical Development to join the Technical Operations / Chemistry, Manufacturing, and Controls (CMC) team at Alumis. The successful candidate will support process development efforts and oversee activities at contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).
Responsibilities
Alumis Inc. is an equal opportunity employer.
