The Associate Director, CMC Analytical Development - Small Molecule is a senior analytical scientist and individual contributor responsible for the development, qualification, and validation of ...
The Associate Director, CMC Analytical Development - Small Molecule is a senior analytical scientist and individual contributor responsible for the development, qualification, and validation of ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$100K - $128K/yr
Analytical Development Principal Research Associate Job Location: 316-318 Northern Ave, Boston, 02210 Openings: 1 Job Type: Full Time Duties: * Design, develop, execute and analyze characterization ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$100K - $128K/yr
Analytical Development Principal Research Associate Job Location: 316-318 Northern Ave, Boston, 02210 Openings: 1 Job Type: Full Time Duties: * Design, develop, execute and analyze characterization ...
The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials ...
Quick apply
The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$109K - $128K/yr
Analytical Development Principal Research Associate LOCATION : 316 Northern Ave., Boston, Massachusetts 02210 OPENINGS: 1 DUTIES: * Independently perform complex experimental procedures using various ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$109K - $128K/yr
Analytical Development Principal Research Associate LOCATION : 316 Northern Ave., Boston, Massachusetts 02210 OPENINGS: 1 DUTIES: * Independently perform complex experimental procedures using various ...
Scientist / Senior Scientist, Analytical Development
Boston, MA ยท On-site
$99K - $135K/yr
Reporting to the Associate Director of Analytical Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for science to the Strand community.
Scientist / Senior Scientist, Analytical Development
Boston, MA ยท On-site
$99K - $135K/yr
Reporting to the Associate Director of Analytical Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for science to the Strand community.
Analytical Characterization Development Scientist - LNPs
Boston, MA ยท On-site
$37 - $41/hr
The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials ...
Analytical Characterization Development Scientist - LNPs
Boston, MA ยท On-site
$37 - $41/hr
The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials ...
The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials ...
The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials ...
Associate Director, Analytical Development - Small Molecule
Boston, MA ยท On-site
$170K - $195K/yr
Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs * Work in a team ...
Associate Director, Analytical Development - Small Molecule
Boston, MA ยท On-site
$170K - $195K/yr
Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs * Work in a team ...
Analytical Development Senior Research Associate
Boston, MA ยท On-site
$72K - $108K/yr
The Analytical Development Senior Research Associate independently performs complex experimental procedures designed through collaboration with their supervisor. Works collaboratively with the ...
Analytical Development Senior Research Associate
Boston, MA ยท On-site
$72K - $108K/yr
The Analytical Development Senior Research Associate independently performs complex experimental procedures designed through collaboration with their supervisor. Works collaboratively with the ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$100K - $128K/yr
Analytical Development Principal Research Associate Job Location: 316-318 Northern Ave, Boston, 02210 Openings: 1 Job Type: Full Time Duties: * Design, develop, execute and analyze characterization ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$100K - $128K/yr
Analytical Development Principal Research Associate Job Location: 316-318 Northern Ave, Boston, 02210 Openings: 1 Job Type: Full Time Duties: * Design, develop, execute and analyze characterization ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$109K - $128K/yr
Analytical Development Principal Research Associate LOCATION : 316 Northern Ave., Boston, Massachusetts 02210 OPENINGS: 1 DUTIES: * Independently perform complex experimental procedures using various ...
Analytical Development Principal Research Associate
Boston, MA ยท On-site
$109K - $128K/yr
Analytical Development Principal Research Associate LOCATION : 316 Northern Ave., Boston, Massachusetts 02210 OPENINGS: 1 DUTIES: * Independently perform complex experimental procedures using various ...
Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs * Work in a team ...
Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs * Work in a team ...
Scientist - Analytical Development, Regeneron Cell Medicines (RCM)
Cambridge, MA ยท On-site
$93.90 - $153.30/hr
The Scientist, RCM Analytical Development, will support Regeneron Cell Medicines (RCM) cell therapy programs by developing, optimizing, and executing biophysical assays to characterize lentiviral ...
Scientist - Analytical Development, Regeneron Cell Medicines (RCM)
Cambridge, MA ยท On-site
$93.90 - $153.30/hr
The Scientist, RCM Analytical Development, will support Regeneron Cell Medicines (RCM) cell therapy programs by developing, optimizing, and executing biophysical assays to characterize lentiviral ...
Lead and manage the Analytical Development Chemistry team responsible for installation of new equipment, assay development and the daily operation of HPLC, LC/MS, CE-SDS, SEC and AUC development ...
Lead and manage the Analytical Development Chemistry team responsible for installation of new equipment, assay development and the daily operation of HPLC, LC/MS, CE-SDS, SEC and AUC development ...
Associate Principal Scientist, Analytical Development
Waltham, MA ยท On-site
$166K - $181K/yr
The Associate Principal Scientist position within Analytical Development leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They will ...
Associate Principal Scientist, Analytical Development
Waltham, MA ยท On-site
$166K - $181K/yr
The Associate Principal Scientist position within Analytical Development leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They will ...
The Senior Scientist - Analytical Development and Transfer is responsible for providing scientific leadership for analytical technology transfers across the CMC portfolio. This role drives analytical ...
The Senior Scientist - Analytical Development and Transfer is responsible for providing scientific leadership for analytical technology transfers across the CMC portfolio. This role drives analytical ...
Lead and manage the Analytical Development Chemistry team responsible for installation of new equipment, assay development and the daily operation of HPLC, LC/MS, CE-SDS, SEC and AUC development ...
Lead and manage the Analytical Development Chemistry team responsible for installation of new equipment, assay development and the daily operation of HPLC, LC/MS, CE-SDS, SEC and AUC development ...
About the Position We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team. This role will provide ...
About the Position We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team. This role will provide ...
Senior Manager, Analytical Development & QC
$121K - $172K/yr
You will lead and drive strategy for analytical method development and phase-appropriate method validation/transfer activities supporting full characterization of small molecule NCEs, from early ...
Senior Manager, Analytical Development & QC
$121K - $172K/yr
You will lead and drive strategy for analytical method development and phase-appropriate method validation/transfer activities supporting full characterization of small molecule NCEs, from early ...
We are seeking a Scientist, RCM Analytical Development to join our Regeneron Cell Medicines (RCM) team. In this role, you will support cell therapy programs by developing, optimizing, and executing ...
We are seeking a Scientist, RCM Analytical Development to join our Regeneron Cell Medicines (RCM) team. In this role, you will support cell therapy programs by developing, optimizing, and executing ...
Analytical Development information
See Boston, MA salary details
$40.7K - $48K
7% of jobs
$48K - $55.4K
14% of jobs
$57.6K is the 25th percentile. Wages below this are outliers.
$55.4K - $62.7K
13% of jobs
$62.7K - $70K
7% of jobs
The median wage is $76.9K / yr.
$70K - $77.3K
9% of jobs
$77.3K - $84.6K
9% of jobs
$84.6K - $91.9K
9% of jobs
$98.3K is the 75th percentile. Wages above this are outliers.
$91.9K - $99.2K
6% of jobs
$99.2K - $106.5K
6% of jobs
$106.5K - $113.8K
16% of jobs
$113.8K - $121.1K
2% of jobs
$40.7K
$81.5K
$121.1K
How much do analytical development jobs pay per year?
What are the key skills and qualifications needed to thrive in Analytical Development?
What is analytical development?
What is the job description of analytical development?
What are some common challenges faced in an Analytical Development role, and how can job seekers prepare for them?
What is the difference between Analytical Development vs Quality Control Analyst?
| Aspect | Analytical Development | Quality Control Analyst |
|---|---|---|
| Primary Focus | Developing and optimizing analytical methods for new products | Performing routine testing to ensure product quality |
| Work Environment | Laboratories involved in method development and validation | Quality control labs conducting batch testing and release |
| Required Credentials | Bachelor's or higher in Chemistry, Biochemistry, or related fields; experience in method development | Bachelor's in Chemistry, Biology, or related fields; experience in testing procedures |
Analytical Development professionals focus on creating and refining analytical methods for new products, while Quality Control Analysts perform routine testing to verify product quality. Both roles require similar educational backgrounds and work in laboratory settings, but their responsibilities differ in scope and purpose.

Associate Director, CMC Analytical Development - Small Molecule
Boston, MA โข On-site
Full-time
PTO
Re-posted 16 days ago
Job description
Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.
Job Summary:
The Associate Director, CMC Analytical Development - Small Molecule is a senior analytical scientist and individual contributor responsible for the development, qualification, and validation of analytical methods supporting small molecule drug substance and drug product programs. Reporting to the Executive Director, CMC Analytical Development, this individual serves as the primary technical owner for analytical activities on assigned programs, covering method development, characterization, stability, and analytical sections of regulatory submissions. This role carries no direct reports but is the key scientific interface with contract analytical laboratories and CDMO analytical teams. It requires deep expertise in small molecule analytical development and testing, a knowledge of GMP laboratory practices, and the ability to manage analytical workstreams independently in a pre-commercial, fast-moving biotech environment.
Work Arrangement & Location:
Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.
Essential Duties and Responsibilities:
- Lead the development, qualification, and validation of analytical methods for small molecule APIs and drug products, including assay, related substances, residual solvents, elemental impurities, dissolution, and physicochemical characterization methods.
- Serve as the primary analytical technical lead for assigned small molecule programs, owning the analytical control strategy from early development through IND, Phase 1-3, and NDA regulatory submissions.
- Design and oversee forced degradation studies, stress testing, and ICH Q1-compliant stability programs for small molecule drug substance and drug product, including protocol development, data review, and shelf-life determination.
- Author and review analytical sections of regulatory submissions including INDs, IMPDs, and NDA modules, and contribute to responses to agency questions on analytical topics with scientific rigor and regulatory awareness.
- Manage method transfer activities to and from contract analytical laboratories and CDMO sites, ensuring methods are transferred, validated, and operationally robust in receiving laboratory.
- Establish and enforce data integrity practices, laboratory compliance standards, and GMP documentation expectations across the small molecule analytical function in alignment with FDA and ICH guidance.
- Evaluate and implement advanced analytical technologies and instrumentation to improve method sensitivity, throughput, and scientific insight across small molecule characterization workflows.
- Partner with Process Chemistry and Product Development teams to provide analytical support for manufacturing campaigns, including in-process testing, impurity profiling, and polymorph/salt form characterization.
- Contribute to the development and review of specifications, certificates of analysis, and release testing strategies for drug substance and drug product, in alignment with regulatory expectations and clinical program needs.
- Operate as a self-directed analytical contributor - independently managing method development priorities, analytical study plans, and GMP documentation while proactively communicating progress, risks, and results to the CMC leadership team and cross-functional partners.
- Perform other duties and responsibilities as assigned
Qualifications:
- Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline preferred; or equivalent industry experience in pharmaceutical analytical development.
- 7+ years of pharmaceutical analytical development experience focused on small molecules in pharmaceutical or biotechnology industry.
- Demonstrated track record of serving as the primary analytical lead on drug substance and drug product programs across multiple development phases.
- Deep expertise in small molecule analytical method development and validation using HPLC, UHPLC, LC-MS, GC, Karl Fischer, dissolution, and related techniques in compliance with ICH Q2(R1) and USP/EP requirements.
- Experience authoring analytical sections of INDs, IMPDs, and NDA filings, and responding to FDA or EMA information requests on analytical methods, specifications, or stability data.
- Proven experience managing method transfer to contract analytical laboratories, including transfer protocol development, method validation oversight, and out-of-specification investigation management.
- Demonstrated experience serving as the primary analytical lead on CMC programs, with the ability to set scientific direction, prioritize workstreams, and drive program accountability without direct reports.
- Skilled in managing external partner relationships including CDMOs and contract laboratories, with hands-on experience in technical oversight, work order management, change control, deviation resolution, and performance monitoring at the working level.
- Strong written and verbal communication skills, with the ability to clearly present scientific data, development recommendations, and program updates to senior leadership and cross-functional partners.
- Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Regulatory Affairs, and Quality in a team-oriented environment.
- Organized and detail-oriented communicator who can manage competing priorities, proactively flag risks, and keep cross-functional stakeholders aligned on timelines and deliverable status.
Salary Range:
The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
Salary Range
$202,000-$215,604 USD
Benefits:
We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:
- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.
Equal Employment Opportunity:
Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable Accommodation:
If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
PrivacyUpon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines