Perform formulation and stability support by performing force degradation studies * Advise and ... CMC sections of FDA and EMA filings Working Environment / Physical Environment * This position ...
Perform formulation and stability support by performing force degradation studies * Advise and ... CMC sections of FDA and EMA filings Working Environment / Physical Environment * This position ...
Perform formulation and stability support by performing force degradation studies * Advise and ... CMC sections of FDA and EMA filings Working Environment / Physical Environment * This position ...
Perform formulation and stability support by performing force degradation studies * Advise and ... CMC sections of FDA and EMA filings Working Environment / Physical Environment * This position ...
Formulation Development Cmc information
See Golden, CO salary details
$34.46 is the 25th percentile. Wages below this are outliers.
$30.78 - $37.01
42% of jobs
The median wage is $38.30 / hr.
$37.01 - $43.24
37% of jobs
$43.24 - $49.46
0% of jobs
$49.46 - $55.69
0% of jobs
$55.69 - $61.92
0% of jobs
$61.92 - $68.15
0% of jobs
$68.15 - $74.38
0% of jobs
$74.38 - $80.60
0% of jobs
$80.60 - $86.83
3% of jobs
$86.83 - $93.06
3% of jobs
$93.06 - $99.29
14% of jobs
$30
$52
$99
How much do formulation development cmc jobs pay per hour?
As of Jul 27, 2026, the average hourly pay for formulation development cmc in Golden, CO is $52.55, according to ZipRecruiter salary data. Most workers in this role earn between $35.72 and $84.13 per hour, depending on experience, location, and employer.
What is the role of CMC in drug development?
In formulation development, CMC (Chemistry, Manufacturing, and Controls) ensures the quality, safety, and efficacy of a drug by establishing manufacturing processes, quality standards, and regulatory documentation. Formulation scientists and CMC teams collaborate to develop stable, scalable drug products that meet regulatory requirements throughout development and commercialization.
What is the salary of formulation R&D?
The salary for a Formulation Development CMC professional typically ranges from $70,000 to $130,000 annually, depending on experience, education, and location. Entry-level roles may start lower, while senior positions with specialized skills or certifications can earn higher salaries. Compensation often includes benefits such as health insurance and bonuses.
What is the highest paying job in pharmaceuticals?
In pharmaceuticals, senior roles such as Vice President of Research and Development or Chief Scientific Officer typically have the highest salaries, often exceeding several hundred thousand dollars annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee drug development, regulatory strategies, and company innovation.
What is the difference between Formulation Development Cmc vs Formulation Scientist?
| Aspect | Formulation Development Cmc | Formulation Scientist |
|---|---|---|
| Credentials | Bachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certifications | Bachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields |
| Work Environment | Pharmaceutical or biotech R&D labs, manufacturing settings | Research labs, development facilities, pharmaceutical companies |
| Industry Usage | Regulatory submissions, product development, manufacturing support | Formulation research, experimental design, product optimization |
Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.
Is formulation part of CMC?
In formulation development roles within CMC (Chemistry, Manufacturing, and Controls), formulation is a core component, involving the design and optimization of drug formulations to ensure stability, efficacy, and manufacturability. These professionals work with analytical tools, quality standards, and regulatory requirements to develop suitable formulations for clinical and commercial products.
What is Formulation Development CMC?
Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.
What are the key skills and qualifications needed to thrive as a Formulation Development CMC specialist, and why are they important?
To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.
What are some typical challenges faced by professionals in Formulation Development CMC, and how are they addressed?
Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.
What job categories do people searching Formulation Development Cmc jobs in Golden, CO look for? The top searched job categories for Formulation Development Cmc jobs in Golden, CO are:
What cities near Golden, CO are hiring for Formulation Development Cmc jobs? Cities near Golden, CO with the most Formulation Development Cmc job openings:
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 17 days ago
Job description
Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.
Why ImmunityBio?
ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
Work with a collaborative team with the ability to work across different areas of the company.
Ability to join a growing company with professional development opportunities.
Position Summary
The Principal Scientist, Analytical Development - Process Sciences will collaborate with internal and external partners to develop, qualify and implement methods across ImmunityBio's platforms and advance our pipeline. This role will serve as a key technical leader and mentor within the Process Sciences department, driving innovation in method development and characterization from early-stage development through late-stage commercialization. The Principal Scientist will support TechOps management and Regulatory Affairs personnel with regulatory filings and provide guidance and consultation to members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams while overseeing timely execution of samples in support of process development activities.
Essential Functions
- Lead the design, development and qualification of robust analytical methods for therapeutic proteins, viral vectors and whole cell products. This includes chromatography, electrophoresis, and cell-based or binding bioassays
- Lead method transfer activities ensuring seamless transfer of assays to and from Quality Control or external Contract Development and Manufacturing Organizations
- Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
- Serve as principal technical subject matter expert (SME). Provide mentorship, training and strategic guidance to less junior team members, fostering a collaborative and high-performing laboratory culture
- Author and review high-quality technical reports, protocols, validation plans, and CMC sections for regulatory submissions (IND/BLA). Ensure all activities align with ICH guidelines and USP/EP compendial requirements
- Collaborate with and monitor contract testing laboratories and consultants, ensuring compliance with company procedures
- Perform and guide others in a variety of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF to assess product quality and characterize products
- Perform formulation and stability support by performing force degradation studies
- Advise and support efforts for method troubleshooting remediation, change, and optimization efforts in conjunction with Quality Control
- Lead support activities for the Process Development teams to characterize process improvements and develop new products
- Oversee the maintenance, calibration and operation analytical equipment and instruments
- Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities
Education & Experience
- Ph.D. in Chemistry, Biochemistry, Molecular Biology or related scientific field with 6+ years of relevant experience in the biopharmaceutical industry required; or
- MSc in Chemistry, Biochemistry, Molecular Biology or related scientific field with 9+ years of relevant experience in the biopharmaceutical industry required; or
- Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific field with 12+ years of relevant experience in the biopharmaceutical industry required.
- Extensive experience in method development, method validation, and method transfer is required.
- Previous supervisory experience strongly preferred
Knowledge, Skills, & Abilities
- Expert knowledge of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF
- Working knowledge of biological assays including ELISA, cell-based potency assays, and flow cytometry
- Familiarity with formulation development is required, hands-on experience with formulation development is highly desired
- Demonstrated ability to translate complex analytical data into actionable insights for cross-functional process development, manufacturing, quality assurance and quality control teams
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Strong project management skills. Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams
- Strong statistical analysis skills
- Strong technical writing skills with experience reviewing and approving: SOPs, analytical test methods, qualification and validation protocols/reports, summary reports, and CMC sections of FDA and EMA filings
Working Environment / Physical Environment
- This position works on site, in Louisville, CO.
- Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
- Working environment is within a GMP BSL-2 laboratory with sufficient equipment to complete the tasks described above.
- Travel up to 10%.
- Occasionally: transporting small equipment, frequent bending, sitting, squatting and lifting up to 40 lbs.
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
$150,000 (entry-level qualifications) to $165,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.