Senior Scientist Biologics Formulation – San Diego, CA

Are you an experienced formulation scientist passionate about advancing biologics development? We are seeking a Senior Scientist specializing in biologics formulation to join our innovative team in San Diego, CA. This role offers the opportunity to contribute to cutting-edge drug product development, optimize formulation strategies, and collaborate with cross-functional teams driving impactful therapies to patients worldwide. If you thrive in a fast-paced research environment and excel in problem-solving, this position is perfect for you.

Drive Innovation in Biologics Formulation

Join a leading biopharmaceutical company in San Diego, CA, dedicated to pioneering biologics therapeutics. As a Senior Scientist in Biologics Formulation, you will play a critical role in designing and developing stable, effective formulations that enhance drug delivery and patient outcomes. The ideal candidate brings deep technical expertise in protein formulation, experience with analytical characterization, and a proactive approach to scientific challenges. This is your chance to impact next-generation biologic therapies through innovative formulation science.

Key Responsibilities of the Senior Scientist Biologics Formulation

Formulation Development: Design, develop, and optimize biologics formulations to ensure stability, efficacy, and manufacturability. Apply advanced formulation strategies to improve drug product performance and patient outcomes.

Analytical Method Support: Collaborate with analytical teams to develop and validate methods for assessing formulation quality, stability, and release profiles. Interpret data to drive formulation decisions and troubleshoot issues.

Product Characterization: Lead studies on the physicochemical and biophysical properties of biologic drug products. Evaluate formulation impacts on product quality attributes and shelf life.

Process Development & Scale-Up: Support scale-up and tech transfer activities for biologics manufacturing processes. Collaborate with process engineering and manufacturing teams to ensure robust and reproducible formulation processes.

Stability and Compatibility Studies: Design and oversee stability studies under various conditions to evaluate formulation robustness. Assess compatibility of formulations with container closure systems and delivery devices.

Cross-Functional Collaboration: Work closely with R&D, clinical, regulatory, and manufacturing teams to align formulation development activities with program timelines and regulatory requirements.

Regulatory Documentation: Prepare and review formulation-related documentation for regulatory submissions, including CMC sections of INDs, BLAs, and other filings. Ensure compliance with applicable regulatory guidelines.

Innovation & Continuous Improvement: Stay abreast of emerging formulation technologies, industry trends, and scientific advancements. Propose and implement innovative solutions to enhance biologics formulation platforms.

Troubleshooting & Risk Management: Identify formulation risks and develop mitigation strategies. Lead root cause analysis and resolution of formulation-related challenges during development and manufacturing.

Leadership & Mentorship: Provide scientific guidance and mentorship to junior scientists and cross-functional team members. Foster a collaborative environment that encourages innovation and professional growth.

What the Client is Looking for in You

As the Senior Scientist Biologics Formulation, the client is seeking a highly skilled and innovative scientist with a strong background in biologics drug product development. You should be a solution-oriented professional who thrives in collaborative, fast-paced environments and has a passion for advancing therapeutic biologics through cutting-edge formulation science.

Expertise in Biologics Formulation and Development

The ideal candidate will have deep technical expertise in protein and biologics formulation, including experience with stability studies, excipient selection, and delivery systems. You should have a proven track record of developing robust formulations that enhance drug stability and efficacy throughout clinical and commercial stages.

Innovative Problem Solver with Scientific Rigor

You must demonstrate the ability to apply scientific principles to design experiments, troubleshoot formulation challenges, and implement innovative solutions. The client values professionals who stay abreast of emerging technologies and industry trends, integrating new approaches to optimize biologic therapies.

Strong Cross-Functional Collaboration and Leadership

The client is looking for someone who excels in working collaboratively across functions such as process development, analytical, manufacturing, and regulatory teams. Your ability to lead projects, communicate scientific data clearly, and influence decision-making will be critical to success.

Data-Driven and Detail-Oriented

Attention to detail and strong analytical skills are essential for interpreting complex experimental data and driving formulation decisions. You should be comfortable managing multiple projects and priorities, ensuring high-quality outcomes within timelines.

Regulatory Knowledge and Compliance Focus

Experience supporting regulatory submissions and ensuring formulation compliance with industry standards is highly valued. You will be expected to prepare technical documentation and work closely with regulatory affairs to meet all relevant guidelines.

Passion for Mentorship and Team Development

The client appreciates candidates who actively mentor junior scientists and contribute to building a collaborative, innovative team culture. A commitment to continuous learning and knowledge sharing is important to drive collective success.

FAQs About the Role – Senior Scientist Biologics Formulation – San Diego, CA

1. What are the key responsibilities of the Senior Scientist in Biologics Formulation?
As a Senior Scientist in Biologics Formulation, you will be responsible for leading the development and optimization of biologic drug formulations, including monoclonal antibodies, recombinant proteins, and other large molecules. This includes pre-formulation studies, stability assessments, and process development for both early- and late-stage biologics. You will also be expected to design and execute experiments, analyze complex data sets, author technical reports, and collaborate cross-functionally with R&D, manufacturing, and regulatory teams.

2. What qualifications and experience are required for this position?
The ideal candidate should hold a Ph.D. in Pharmaceutics, Biochemistry, Chemical Engineering, or a related field with 5+ years of relevant industry experience, or an M.S. with 8+ years of hands-on experience in biologics formulation. A strong track record in developing injectable formulations, lyophilized products, and/or delivery systems for protein therapeutics is essential. Experience with analytical characterization, regulatory submissions (IND/BLA), and working in a cGMP environment is highly desirable.

3. What technical skills are important for success in this role?
Proficiency in formulation design, analytical techniques (e.g., HPLC, SEC, DLS), protein stability assessment, and DOE-based experimental design is crucial. Knowledge of biophysical characterization tools, such as DSC and FTIR, and familiarity with formulation challenges related to aggregation, viscosity, and immunogenicity will give candidates a competitive advantage. Familiarity with Quality by Design (QbD) principles and statistical software (e.g., JMP, Minitab) is also beneficial.

4. What kind of projects will I be working on?
You will work on a range of biologic drug development programs at different stages—from discovery to late-phase clinical trials. Projects include formulation screening, stability studies, scale-up development, and technology transfer to manufacturing. You may also contribute to innovation-driven programs focused on novel delivery systems and formulation technologies to improve drug stability and patient compliance.

5. What collaboration and team dynamics can I expect?
This role is highly collaborative. You will work closely with scientists in analytical development, process development, quality control, and regulatory affairs. You’ll also interact with external vendors and CDMOs as needed. The company values open communication, teamwork, and a science-first mindset that drives data-based decisions and innovation.

6. Is there an opportunity for growth or leadership in this role?
Yes. The company encourages career development and offers opportunities to lead formulation development projects, mentor junior scientists, and contribute to strategic decisions. High-performing candidates may advance to leadership roles within the formulation or broader R&D organization, depending on performance and business needs.

7. What is the work environment and company culture like?
The company fosters a collaborative, mission-driven environment focused on innovation, scientific rigor, and improving patient outcomes. The San Diego site features modern laboratory facilities and supports a culture of continuous learning, open dialogue, and shared success. Employees are encouraged to take initiative, voice ideas, and contribute meaningfully to projects.

8. Will I be involved in regulatory filings or external communications?
Yes. You may be responsible for drafting or reviewing sections of regulatory submissions (e.g., INDs, BLAs) related to formulation development. Participation in regulatory meetings or audits may also be required. Strong written and verbal communication skills are essential for preparing technical reports, SOPs, and regulatory documentation.

What Remuneration Can You Expect from This Job?

As a Senior Scientist in Biologics Formulation based in San Diego, CA, you can expect a competitive compensation package aligned with industry standards for experienced professionals in the biotech and pharmaceutical sectors. The remuneration typically includes:

Base Salary

The base salary for a Senior Scientist in biologics formulation usually depends on experience, education, and the company’s size. In San Diego’s biotech market, annual base salaries generally range from $110,000 to $150,000, with higher pay possible for candidates with advanced degrees (PhD) and extensive experience.

Performance-Based Bonuses

Many companies offer annual performance bonuses tied to individual and project success, team goals, and company milestones. These bonuses typically range from 5% to 15% of the base salary, incentivizing innovation and effective project delivery.

Equity & Stock Options

Biotech firms often provide stock options or restricted stock units (RSUs) as part of the total compensation package, especially for roles involved in key drug development programs. Equity incentives help align your rewards with the company’s long-term success and can be a valuable part of your overall earnings.

Benefits & Perks

Standard benefits usually include:

Comprehensive health, dental, and vision insurance
401(k) retirement plans with employer matching
Paid time off and holidays
Professional development and continuing education support
Wellness programs and flexible work arrangements

Relocation Assistance

For candidates moving to San Diego from other locations, many companies provide relocation packages to ease the transition. This can include moving expenses, temporary housing assistance, and travel reimbursements.

Total Compensation Potential

Taking into account base salary, bonuses, equity, and benefits, total compensation for a Senior Scientist in biologics formulation can range between $120,000 and $180,000 annually, with potential for growth based on performance and career advancement opportunities.

How to Apply

If you are an experienced and innovative scientist specializing in biologics formulation, we invite you to apply for the Senior Scientist Biologics Formulation position based in San Diego, CA. This role offers an exciting opportunity to contribute to cutting-edge biologics development within a collaborative and dynamic biotech environment.

To apply, please submit your updated resume and a cover letter outlining your relevant experience in biologics formulation, drug product development, analytical techniques, and project leadership. Be sure to highlight your expertise in formulation design, stability studies, and regulatory compliance, as well as your ability to work cross-functionally to drive successful biologics development programs.

This position provides a rewarding career path where you will play a key role in advancing innovative therapies and shaping the future of biologics. Apply today to join a leading team and make a meaningful impact in the field of biologics formulation!

For more information or to explore similar opportunities, visit our Biologics Recruiting Experts Page.

Job Category: Biologics

Job Type: Full Time

Job Location: San Diego

Senior Scientist Biologics Formulation – San Diego, CA