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$89K

$191.4K

$287.5K

How much do director analytical development biologics jobs pay per year?

As of Jun 16, 2026, the average yearly pay for director analytical development biologics in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

What does a Director of Analytical Development Biologics do?

A Director of Analytical Development Biologics leads teams responsible for developing, validating, and implementing analytical methods used to characterize and ensure the quality of biologic drugs. This role oversees method development for protein therapeutics, monoclonal antibodies, or other biologics, and ensures compliance with regulatory standards. The director collaborates with research, manufacturing, and regulatory teams to support drug development and approval processes, and may also manage external partnerships or contract labs. Strong leadership, scientific expertise, and project management skills are essential in this position.

What are the main challenges faced by a Director of Analytical Development in Biologics, and how can they be addressed?

One of the primary challenges in this role is ensuring robust analytical methods are developed, validated, and transferred across multiple sites while keeping up with evolving regulatory requirements. Directors must navigate complex biologics characterization and lead cross-functional teams to align project timelines, often under tight deadlines. Building strong communication channels and fostering collaboration with R&D, quality, and manufacturing teams is key to overcoming these hurdles. Proactively staying updated on regulatory guidance and investing in team training also helps address technical and compliance challenges effectively.

What are the key skills and qualifications needed to thrive as a Director Analytical Development Biologics, and why are they important?

To thrive as a Director Analytical Development Biologics, you need advanced expertise in analytical chemistry, biologics characterization, and regulatory requirements, usually backed by a PhD or relevant advanced degree and extensive industry experience. Familiarity with chromatographic methods, mass spectrometry, bioassay platforms, and regulatory submission systems such as IND/BLA is crucial, along with knowledge of GMP/GLP standards. Strong leadership, strategic thinking, and cross-functional communication skills enable effective team management and collaboration with stakeholders. These skills ensure the robust development, validation, and regulatory compliance of analytical methods critical to biologics program success.

What is the difference between Director Analytical Development Biologics vs Senior Analytical Scientist?

AspectDirector Analytical Development BiologicsSenior Analytical Scientist
ResponsibilitiesOversees analytical development strategies, manages teams, and ensures regulatory compliancePerforms analytical testing, method development, and data analysis under supervision
CredentialsTypically requires advanced degrees (PhD or MS) and leadership experienceUsually requires a bachelor's or master's degree with specialized analytical skills
Work EnvironmentLeadership role in R&D or manufacturing settings within biologics companiesHands-on laboratory work in biotech or pharmaceutical labs

The main difference is that the Director Analytical Development Biologics leads and manages analytical development teams and strategies, while the Senior Analytical Scientist focuses on executing analytical tasks and supporting development efforts. The director role involves higher-level planning, oversight, and regulatory responsibilities, whereas the senior scientist role is more technical and operational.

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Director Analytical Development Biologics jobs near you
Infographic showing various Director Analytical Development Biologics job openings in the United States as of June 2026, with employment types broken down into 85% Full Time, and 15% Part Time. Highlights an 85% Physical, 5% Hybrid, and 10% Remote job distribution, with an average salary of $191,412 per year, or $92 per hour.

Director, Analytical Development

BioNTech SE

Gaithersburg, MD

$168K - $268K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 4 days ago

Job description

Gaithersburg, US   |   full time   |   Job ID: 11211 

About the Role:

As Director of Analytical Development, you will play a pivotal role in advancing BioNTech's mission to revolutionize medicine. Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions. Partnering with cross-functional teams in Process Development, Global Technical Development, AS&T, Regulatory, and Quality, you will operate primarily in non-GMP laboratories to deliver impactful solutions that shape the future of biologics development.

This role offers an opportunity to lead innovative analytical strategies in a dynamic environment where your contributions will directly influence global regulatory submissions and product commercialization.

Your Contribution:

Collaborate with SMEs and GTD leads to develop robust methods, analytical control strategies, and seamless transfer packages
Proactively identify analytical risks and data gaps; design and implement risk mitigation studies (e.g., characterization, comparability, stability)
Establish internal best practices for phase-appropriate CMC hand-offs and analytical playbooks
Define CQAs and evolve associated control strategies across development phases aligned with ICH Q6B guidelines
Lead or contribute significantly to CMC documentation (IND/IMPDs, BLAs/MAAs) and technical responses related to analytics
Engage in hands-on laboratory work including method development, troubleshooting, and oversight of testing activities

A Good Match:

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 10+ years of relevant experience; or MS with 12+ years of industry experience
Extensive expertise in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage/BLA readiness experience preferred
Proven success leading BLA readiness/PPQ activities; commercial launch experience is a plus
Hands-on experience in biologics method development, qualification/validation, transfer processes; ADC-specific analytics knowledge desirable
Strong understanding of biologics CMC guidelines (ICH Q6B), analytical control strategies, specification setting & justification
Demonstrated leadership within matrixed environments; excellent communication skills
Global submission experience across regions (e.g., US/EU/China) is advantageous
Willingness to travel domestically/internationally based on program needs

If the position is filled in the US, the Expected Pay Range is $168,100/year to $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.

Your Benefits

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

  • Medical, Dental and Vision Insurance
  • Life, AD&D, Critical Illness Insurance
  • Pre-tax HSA & FSA, DCRA Spending Accounts
  • Employee Assistance & Concierge Program (EAP) available 24/7
  • Parental and Childbirth Leave & Family Planning Assistance
  • Sitterstream: Virtual Tutoring & Childcare Membership
  • Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
  • 401(K) Plan with Company Match
  • Tuition Reimbursement & Student Loan Assistance Programs
  • Wellbeing Incentive Platforms & Incentives
  • Professional Development Programs
  • Commuting Allowance and subsidized parking
  • Discounted Home, Auto & Pet Insurance

...and more! More details to be shared.
 

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation's capital. The city's strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg's manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

Apply