Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met. * Oversee analytical method ...
Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met. * Oversee analytical method ...
Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met. * Oversee analytical method ...
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Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met. * Oversee analytical method ...
JOB SUMMARY Lead the establishment of methods in the Analytical Development (AD) and Quality ... Direct line management experience is required. JOB RESPONSIBILITIES * Experience with AAV assay ...
JOB SUMMARY Lead the establishment of methods in the Analytical Development (AD) and Quality ... Direct line management experience is required. JOB RESPONSIBILITIES * Experience with AAV assay ...
Plan and manage short-term and long-term development activities. Develop and/or review technical ... D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the ...
Plan and manage short-term and long-term development activities. Develop and/or review technical ... D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the ...
JOB SUMMARY Lead the establishment of methods in the Analytical Development (AD) and Quality ... Direct line management experience is required. JOB RESPONSIBILITIES * Experience with AAV assay ...
Quick apply
JOB SUMMARY Lead the establishment of methods in the Analytical Development (AD) and Quality ... Direct line management experience is required. JOB RESPONSIBILITIES * Experience with AAV assay ...
The Impact You Will Make As an Analytical Development Scientist II, you will play a critical role ... manage multiple priorities, and meet deadlines in a fast-paced pharmaceutical manufacturing ...
The Impact You Will Make As an Analytical Development Scientist II, you will play a critical role ... manage multiple priorities, and meet deadlines in a fast-paced pharmaceutical manufacturing ...
The Impact You Will Make As an Analytical Development Scientist II, you will play a critical role ... manage multiple priorities, and meet deadlines in a fast-paced pharmaceutical manufacturing ...
The Impact You Will Make As an Analytical Development Scientist II, you will play a critical role ... manage multiple priorities, and meet deadlines in a fast-paced pharmaceutical manufacturing ...
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San Diego, CA · On-site
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Manager, Analytical Lab
Roosevelt, UT · On-site
Provides direction, training and development to assigned Regional Analytical Lab Chemists and Technicians. * Manage lab and personnel administrative functions. * Responsible for managing lab ...
Manager, Analytical Lab
Roosevelt, UT · On-site
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San Diego, CA · On-site
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Scientist I/II, Analytical Development
San Diego, CA · On-site
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Analytical Development Senior Scientist
Boston, MA · On-site
$122.40 - $183.60/hr
Able to manage multiple priorities in a fast‑paced environment while maintaining timelines and ... D. with 2+ years or Master's degree with 5+ years of relevant analytical development experience.
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Provides direction, training and development to assigned Regional Analytical Lab Chemists and Technicians. * Manage lab and personnel administrative functions. * Responsible for managing lab ...
Manager, Analytical Lab
Roosevelt, UT · On-site
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Scientist II, Analytical Development
Cambridge, MA · On-site
$117K - $157K/yr
We are seeking a Scientist II to join our Analytical Development team as a Liquid Chromatography ... Management Additional Information The base compensation range for this role is: $117,000.00-$157 ...
Manager Analytical Development information
See salary details
$33K - $42.1K
2% of jobs
$42.1K - $51.2K
8% of jobs
$58.1K is the 25th percentile. Wages below this are outliers.
$51.2K - $60.3K
19% of jobs
$60.3K - $69.4K
20% of jobs
The median wage is $69.7K / yr.
$69.4K - $78.5K
16% of jobs
$85.5K is the 75th percentile. Wages above this are outliers.
$78.5K - $87.5K
13% of jobs
$87.5K - $96.6K
5% of jobs
$96.6K - $105.7K
11% of jobs
$105.7K - $114.8K
2% of jobs
$114.8K - $123.9K
2% of jobs
$123.9K - $133K
2% of jobs
$33K
$77.4K
$133K
How much do manager analytical development jobs pay per year?
What is a manager analytical development?
A Manager Analytical Development oversees the development, validation, and implementation of analytical methods to support product development and manufacturing. They ensure compliance with regulatory standards, manage a team of scientists, and collaborate with cross-functional departments to drive innovation and efficiency. Their role is critical in ensuring product quality, consistency, and regulatory approval.
What are the typical day-to-day responsibilities for a manager analytical development?
As a Manager Analytical Development, your typical day involves overseeing laboratory teams, managing analytical method development and validation projects, and ensuring compliance with relevant quality standards. You’ll often collaborate with R&D, quality assurance, and production departments to support product development timelines and troubleshoot analytical challenges. Additionally, you may conduct data reviews, prepare regulatory documentation, and participate in meetings to drive project progress. Your role also includes mentoring team members and optimizing lab workflows for productivity and accuracy.
What are the key skills and qualifications needed to thrive in the manager analytical development position, and why are they important?
To excel as a Manager Analytical Development, you typically need an advanced degree in chemistry, biochemistry, or a related field, along with experience in analytical method development and leadership. Familiarity with laboratory information management systems (LIMS), chromatographic software (HPLC/UPLC), and regulatory standards such as ICH and FDA guidelines is common. Outstanding project management, team leadership, and communication skills help you effectively coordinate cross-functional projects and mentor staff. These competencies enable delivery of high-quality analytical solutions, ensure regulatory compliance, and drive successful product development.
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States with the most job openings for Manager Analytical Development jobs include:
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The top searched job categories for Manager Analytical Development jobs are:
- Remote Analytical Chemist Gas Chromatography
- Internship Pharmaceutical Analytical Chemistry
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Senior Director, Analytical Development & Quality Control
Boston, MA • On-site
Full-time
Posted 28 days ago
Job description
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
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 Rhythm's portfolio, spanning discovery through commercialization and lifecycle management. This role is accountable for defining and executing phase-appropriate analytical control strategies, enabling robust product characterization, and ensuring compliant, timely delivery of analytical data to support regulatory submissions and commercial supply.
You will lead and develop a high-performing organization while overseeing external partners, including CDMOs, CROs, and contract laboratories, to deliver analytical development and QC activities across drug substance and drug product. As a key member of the Technical Operations leadership team, you will drive cross-functional alignment, influence organizational strategy, and represent Analytical Development and QC in regulatory and governance interactions.
Responsibilities and Duties
Strategic Leadership & Analytical Development
- Define and execute end-to-end analytical strategies across the product lifecycle, including method development, validation, transfer, and lifecycle management from raw materials through drug substance and drug product.
- Establish phase-appropriate control strategies, specifications, and analytical approaches aligned with regulatory expectations and commercial readiness.
- Drive innovation in analytical technologies and methodologies, translating new approaches into robust, scalable platforms for development and commercial testing.
- Lead product characterization strategies, including identification and control of critical quality attributes (CQAs), impurity profiling, comparability, and stability programs.
- Act as Head of Quality Control for analytical testing supporting US and EU market authorization holders (MAHs), ensuring compliant release and support of clinical and commercial products.
- Oversee QC testing activities, including in-process, release, stability, reference standards, and impurity monitoring programs for drug substance and drug product.
- Ensure laboratories (internal and external) operate in compliance with cGMP, data integrity, and global regulatory requirements.
- Provide oversight for investigations, deviations, OOS/OOT results, complaints, and root cause analyses, ensuring timely and compliant resolution.
- Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met.
- Oversee analytical method transfer activities, including protocol design, execution, and performance monitoring across internal and external sites.
- Establish and manage budgets, resource plans, timelines, and risk mitigation strategies across programs.
- Build and maintain strong supplier relationships and oversee regulatory inspections and audit readiness of external laboratories.
- Provide strategic leadership for regulatory submission activities, including authoring, reviewing, and approving Module 3 analytical sections for INDs, IMPDs, NDAs, MAAs, and lifecycle filings.
- Lead analytical responses to health authority queries and represent the function during regulatory interactions and inspections.
- Ensure analytical development activities are aligned with ICH guidelines and global regulatory expectations.
- Partner with Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Project Management, and Research functions to advance development programs.
- Serve as analytical subject matter expert on cross-functional CMC and Product Development Teams.
- Influence strategic decision-making and drive alignment across internal stakeholders and senior leadership.
- Build, lead, and develop a high-performing analytical development and QC organization, including hiring, coaching, mentoring, and succession planning.
- Foster a culture of scientific excellence, innovation, accountability, and continuous improvement.
Qualifications and Skills
Education & Experience
- PhD (preferred) or MS in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline.
- 12+ years (PhD) or equivalent experience in analytical development within the pharmaceutical or biotechnology industry, including significant leadership experience.
- Demonstrated experience leading analytical development and QC organizations supporting small molecule and/or peptide drug development across the lifecycle (discovery through commercialization).
- Deep expertise in analytical method development, validation, transfer, and lifecycle management.
- Strong knowledge of small molecule and/or peptide analytical techniques, including chromatography (HPLC/UPLC), mass spectrometry, impurity analysis, stability, and characterization.
- Extensive experience with control strategy development, specification setting, comparability, and regulatory-ready analytical packages.
- Proven experience overseeing stability programs, impurity tracking, and reference standard programs.
- Familiarity with quality management systems and procedures for change management, investigations, deviations, and document control.
- Strong understanding of cGMP, data integrity principles, and ICH guidelines.
- Demonstrated experience supporting global regulatory submissions (IND, IMPD, NDA, MAA) and regulatory inspections.
- Proven ability to lead cross-functional teams and influence decision-making in a matrixed organization.
- Strong external vendor management experience, including CDMOs and CRO oversight in a virtual environment.
- Track record of managing complex programs, solving technical and regulatory challenges, and delivering under aggressive timelines.
- Excellent communication and presentation skills, with the ability to convey complex technical information to diverse stakeholders.
- Strong strategic thinking, problem-solving, and risk management capabilities.
- Ability to manage multiple priorities in a fast-paced, dynamic, and highly collaborative environment.
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $210,000 - $300,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients' lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
About Rhythm Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Boston, MA, US
Year founded
2008