Position Summary The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer ...
Position Summary The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer ...
The Analytical Development (AD) Training Specialist will be supporting client's Analytical Development organization by managing training curricula, role specific training assignments, and training ...
The Analytical Development (AD) Training Specialist will be supporting client's Analytical Development organization by managing training curricula, role specific training assignments, and training ...
Opportunity Overview As the Senior Director, Analytical Development and Quality Control , you will provide strategic and technical leadership for analytical development and quality control across ...
Opportunity Overview As the Senior Director, Analytical Development and Quality Control , you will provide strategic and technical leadership for analytical development and quality control across ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท Hybrid
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท Hybrid
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Opportunity Overview As the Senior Director, Analytical Development and Quality Control , you will provide strategic and technical leadership for analytical development and quality control across ...
Quick apply
Opportunity Overview As the Senior Director, Analytical Development and Quality Control , you will provide strategic and technical leadership for analytical development and quality control across ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท Hybrid
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท Hybrid
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Training Specialist - Pharmaceutical Analytical Development
Lexington, MA ยท On-site
$23 - $35/hr
The Analytical Development (AD) Training Specialist will be supporting client's Analytical Development organization by managing training curricula, role specific training assignments, and training ...
Training Specialist - Pharmaceutical Analytical Development
Lexington, MA ยท On-site
$23 - $35/hr
The Analytical Development (AD) Training Specialist will be supporting client's Analytical Development organization by managing training curricula, role specific training assignments, and training ...
Training Specialist - Pharmaceutical Analytical Development
Lexington, MA ยท On-site
$23 - $35/hr
The Analytical Development (AD) Training Specialist will be supporting client's Analytical Development organization by managing training curricula, role specific training assignments, and training ...
Training Specialist - Pharmaceutical Analytical Development
Lexington, MA ยท On-site
$23 - $35/hr
The Analytical Development (AD) Training Specialist will be supporting client's Analytical Development organization by managing training curricula, role specific training assignments, and training ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท On-site
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท On-site
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท On-site
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Director, Analytical Development - Small Molecule
Waltham, MA ยท On-site
$211K - $257K/yr
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Quick apply
The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug ...
Scientist II-Analytical, Research & Development (ARD)
Devens, MA ยท On-site
$115K - $125K/yr
Scientist II-Analytical, Research & Development (ARD) Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in ...
Quick apply
Scientist II-Analytical, Research & Development (ARD)
Devens, MA ยท On-site
$115K - $125K/yr
Scientist II-Analytical, Research & Development (ARD) Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in ...
Biomedicines is seeking a Senior Director, Analytical Development & Quality Control to set the strategic direction and lead execution of analytical development and quality control for biologics ...
Biomedicines is seeking a Senior Director, Analytical Development & Quality Control to set the strategic direction and lead execution of analytical development and quality control for biologics ...
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 ...
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 ...
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 ...
Scientist I-Analytical, Research & Development (ARD)
Devens, MA ยท On-site
$90K - $105K/yr
Scientist I-Analytical, Research & Development Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our ...
Quick apply
Scientist I-Analytical, Research & Development (ARD)
Devens, MA ยท On-site
$90K - $105K/yr
Scientist I-Analytical, Research & Development Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our ...
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 ...
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 ...
Senior Manager, Analytical Development & QC
Cambridge, MA ยท On-site
$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
Cambridge, MA ยท On-site
$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 ...
Analytical Development information
See Lowell, MA salary details
$37.2K - $43.9K
7% of jobs
$43.9K - $50.5K
14% of jobs
$52.6K is the 25th percentile. Wages below this are outliers.
$50.5K - $57.2K
13% of jobs
$57.2K - $63.9K
7% of jobs
The median wage is $70.2K / yr.
$63.9K - $70.6K
9% of jobs
$70.6K - $77.2K
9% of jobs
$77.2K - $83.9K
9% of jobs
$89.7K is the 75th percentile. Wages above this are outliers.
$83.9K - $90.6K
6% of jobs
$90.6K - $97.2K
6% of jobs
$97.2K - $103.9K
16% of jobs
$103.9K - $110.6K
2% of jobs
$37.2K
$74.4K
$110.6K
How much do analytical development jobs pay per year?
What are the key skills and qualifications needed to thrive in 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.
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What is the job description of analytical development?
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Full-time
Posted 8 days ago
Job description
The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule and antibody-drug conjugate (ADC) programs, with an emphasis on drug product, and antibody/ADC-focused analytical activities. This individual will be responsible for operating in a 100% outsourced environment to establish and manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs.
As a key member of the Technical Operations team, the Director will collaborate cross-functionally with Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CRO/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.
Key Responsibilities
Analytical Development Leadership
- Develop and execute phase-appropriate analytical strategies supporting small molecule and ADC development, with an emphasis on Drug Product and ADC method development for assigned programs.
- Lead analytical characterization efforts for assigned programs, including:
- Phase-appropriate small molecule oral solid dose drug product method development and testing (tablets, capsules, gelcaps)
- Phase-appropriate method development supporting antibody manufacture, ADC conjugation, and parenteral drug product manufacture.
- Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.
- Ensure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions.
- Serve as the company's analytical subject matter expert for ADC development.
- Support characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities.
- Guide implementation and interpretation of advanced analytical techniques such as: HPLC, UPLC, LC-MS, HRMS, SEC, CE-SDS, icIEF, HIC, ELISA, and bioassays.
- Collaborate with external CDMOs and internal process development teams to define CQAs and control strategies for ADC products.
Quality Control Oversight
- Establish and lead QC strategies across clinical manufacturing operations for assigned programs.
- Oversee external GMP testing activities including raw materials, IPCs, release testing and stability programs.
- Ensure timely release and disposition support for clinical materials.
- Manage investigations involving OOS, OOT, deviations, and laboratory events.
Regulatory and Quality Support
- Author and review analytical sections of regulatory submissions including: INDs, IMPDs, BLAs, NDAs, and CTAs.
- Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations.
- Support establishment of specifications and analytical control strategies throughout the product lifecycle.
- May participate in regulatory agency interactions and inspections.
- Ensure compliance with cGMP, GLP, GCP, and data integrity requirements.
- Partner closely with Quality Assurance to maintain inspection readiness.
- Support audits of contract testing laboratories and manufacturing partners.
External Partner Management
- Manage relationships with contract laboratories and CDMOs.
- Oversee method transfers, validation activities, and technical governance of external laboratories.
- Establish performance metrics and ensure delivery against development and manufacturing timelines.
- Evaluate and implement new analytical technologies and outsourced capabilities as needed.
Required Qualifications
Education
- Ph.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.
Experience
- 12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience with experience in both OSD drug product analytical development and in biologics/ADC analytical development.
- Demonstrated experience supporting both small molecule drug product and biologic/ADC development programs.
- Proven track record advancing products from early development through late-stage clinical development and/or commercialization.
- Demonstrated success working with CDMOs and global development partners.
Technical Expertise
Strong working knowledge of:
- Analytical method development and validation
- Stability programs and specification setting
- Quality control laboratory operations
- GMP analytical testing
- Oral solid dose characterization and phase-appropriate method development, including discriminatory dissolution method development
- ADC analytical characterization
- Biologics testing methodologies
- ICH Q1, Q2, Q3, Q6, Q7, Q8, Q9, Q10, and Q14 guidance
- Regulatory submissions and health authority interactions
Leadership Competencies
- Strategic thinker with strong business and scientific acumen.
- Excellent project management and organizational skills.
- Strong communication and influence skills across scientific, quality, regulatory, and program teams
- Ability to travel (20%) to CDMO domestic and international sites.
- Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools).
- High level of personal integrity, commitment to excellence and to our patients.
- Experience in developing and commercializing drugs for oncology is preferred.
This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $193,877 to $232,875. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
Recruitment fraud statement
Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:
- Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
- We do not conduct interviews through RingCentral, Skype or Telegram.
- Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
- You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
- To report job scams, head to ReportFraud.ftc.gov.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.
About Treeline Biosciences
Sourced by ZipRecruiter
Company size
51 - 200 Employees
Headquarters location
Stamford, CT, US
Year founded
2021