Harmony Biosciences is recruiting for a Senior Manager, Analytical Development in our Plymouth Meeting Office. This position is a key contributor within Harmony's Technical Operations organization ...
Harmony Biosciences is recruiting for a Senior Manager, Analytical Development in our Plymouth Meeting Office. This position is a key contributor within Harmony's Technical Operations organization ...
SUMMARY Lundbeck Seattle Biopharmaceuticals is seeking a highly motivated and experienced scientific leader to manage the Characterization and Development team within the Analytical Development ...
SUMMARY Lundbeck Seattle Biopharmaceuticals is seeking a highly motivated and experienced scientific leader to manage the Characterization and Development team within the Analytical Development ...
Director, Analytical Development
Bedford, MA · Hybrid
$185K - $232K/yr
The role will represent Analytical Development on CMC teams and provide leadership that will be ... The individual will have demonstratable expertise in managing analytical activities at external ...
Director, Analytical Development
Bedford, MA · Hybrid
$185K - $232K/yr
The role will represent Analytical Development on CMC teams and provide leadership that will be ... The individual will have demonstratable expertise in managing analytical activities at external ...
Position Overview Immunome is seeking a highly experienced and collaborative Senior Manager, Analytical Development and QC, Small Molecule to lead analytical method development, validation, and ...
Position Overview Immunome is seeking a highly experienced and collaborative Senior Manager, Analytical Development and QC, Small Molecule to lead analytical method development, validation, and ...
... management, and overall CMC analytical strategy. * Lead and oversee analytical development ... execution across internal and external teams to support the development, characterization, and ...
... management, and overall CMC analytical strategy. * Lead and oversee analytical development ... execution across internal and external teams to support the development, characterization, and ...
The role is based in our Uppsala office, reporting to Manager, Analytical Development. In this role, you will play a central part in developing, optimizing, and implementing analytical quality ...
The role is based in our Uppsala office, reporting to Manager, Analytical Development. In this role, you will play a central part in developing, optimizing, and implementing analytical quality ...
... PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to ...
... PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to ...
Leads an analytical GMP group for testing development stage pharmaceutical compounds including ... Manage internal stability testing programs, validation, qualification, and transfer of analytical ...
Leads an analytical GMP group for testing development stage pharmaceutical compounds including ... Manage internal stability testing programs, validation, qualification, and transfer of analytical ...
... PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to ...
... PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to ...
Director, Analytical Development
South San Francisco, CA · On-site
$225K - $250K/yr
THE ROLE We are seeking an experienced and highly motivated Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug ...
Director, Analytical Development
South San Francisco, CA · On-site
$225K - $250K/yr
THE ROLE We are seeking an experienced and highly motivated Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug ...
Demonstrated leadership experience managing external partners, including CROs and CDMOs, to ensure ... analytical development and quality. * Strong strategic thinking and innovation mindset with the ...
Demonstrated leadership experience managing external partners, including CROs and CDMOs, to ensure ... analytical development and quality. * Strong strategic thinking and innovation mindset with the ...
BrainChild Bio is seeking to hire an experienced Scientist in Analytical Development to add to our ... Train and manage direct reports. Qualifications: * Degree in biology, bioengineering, immunology ...
Quick apply
BrainChild Bio is seeking to hire an experienced Scientist in Analytical Development to add to our ... Train and manage direct reports. Qualifications: * Degree in biology, bioengineering, immunology ...
Analytical Development Scientist
$95K - $140K/yr
Analytical Development Scientist 1 Pace Life Sciences is a premier Contract Research and ... Ability to manage people and projects PHYSICAL/MENTAL REQUIREMENTS: The physical demands described ...
Analytical Development Scientist
$95K - $140K/yr
Analytical Development Scientist 1 Pace Life Sciences is a premier Contract Research and ... Ability to manage people and projects PHYSICAL/MENTAL REQUIREMENTS: The physical demands described ...
Manager, Analytical Development and Quality Control (Brisbane, CA)
Brisbane, CA · On-site
$174K - $198K/yr
Position The Manager, Analytical Development and Quality Control provides strategic and technical leadership for analytical CMC activities across multiple programs, with a strong emphasis on ...
Manager, Analytical Development and Quality Control (Brisbane, CA)
Brisbane, CA · On-site
$174K - $198K/yr
Position The Manager, Analytical Development and Quality Control provides strategic and technical leadership for analytical CMC activities across multiple programs, with a strong emphasis on ...
Scientist, Analytical Development
Seattle, WA · On-site
$135K - $155K/yr
BrainChild Bio is seeking to hire an experienced Scientist in Analytical Development to add to our ... Train and manage direct reports. Qualifications: * Degree in biology, bioengineering, immunology ...
Scientist, Analytical Development
Seattle, WA · On-site
$135K - $155K/yr
BrainChild Bio is seeking to hire an experienced Scientist in Analytical Development to add to our ... Train and manage direct reports. Qualifications: * Degree in biology, bioengineering, immunology ...
Key Responsibilities: 1. Analytical program management: · Manages client analytical programs with a focus on quality and timeline. · Leads analytical method development, transfer, and qualification ...
Quick apply
Key Responsibilities: 1. Analytical program management: · Manages client analytical programs with a focus on quality and timeline. · Leads analytical method development, transfer, and qualification ...
The Director will manage a team of scientists on multiple projects in multiple analytical development specialty areas, such as chromatography, spectroscopy, drug release, understanding drug ...
The Director will manage a team of scientists on multiple projects in multiple analytical development specialty areas, such as chromatography, spectroscopy, drug release, understanding drug ...
The Director will manage a team of scientists on multiple projects in multiple analytical development specialty areas, such as chromatography, spectroscopy, drug release, understanding drug ...
Quick apply
The Director will manage a team of scientists on multiple projects in multiple analytical development specialty areas, such as chromatography, spectroscopy, drug release, understanding drug ...
Lead development, qualification, validation, and lifecycle management strategies for cell-based ... Partner cross-functionally with Quality, QC, and Analytical Sciences & Technology (AS&T) to enable ...
Lead development, qualification, validation, and lifecycle management strategies for cell-based ... Partner cross-functionally with Quality, QC, and Analytical Sciences & Technology (AS&T) to enable ...
Lead development, qualification, validation, and lifecycle management strategies for cell-based ... Partner cross-functionally with Quality, QC, and Analytical Sciences & Technology (AS&T) to enable ...
Lead development, qualification, validation, and lifecycle management strategies for cell-based ... Partner cross-functionally with Quality, QC, and Analytical Sciences & Technology (AS&T) to enable ...
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 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 is a Manager Analytical Development job?
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 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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Other
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Posted 9 days ago
Job description
Harmony Biosciences is recruiting for a Senior Manager, Analytical Development in our Plymouth Meeting Office. This position is a key contributor within Harmony's Technical Operations organization, supporting the analytical development and oversight of drug substance and drug product activities across external manufacturing partners. The individual in this position will play an integral role in coordinating and executing analytical strategies for both clinical and commercial programs, ensuring continuity of supply and adherence to the highest quality standards. Working cross-functionally, this role helps drive the delivery of safe, reliable, and high-quality pharmaceutical products to patients by enabling seamless execution of analytical activities across the development lifecycle.
Responsibilities include but are not limited to:
- Serve as an analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product (oral solids/liquids and other dosage forms) development and manufacturing at contractor sites
- Lead and support analytical development activities at multiple contractor sites related to analytical method development, method improvements, product characterization and comparability assessments for Harmony's early and late-stage programs
- Direct technical oversight of multiple Contract Organizations (COs), with the following responsibilities:
- Serve as technical resource on drug substance and drug product aspects with particular emphasis in analytical chemistry and associated methodologies
- Provide oversight and serve as technical lead for the execution of method development, method improvement and method validation activities
- Manage laboratory deviations/investigations to successful closure in a timely manner as product SME in close and seamless collaboration with Harmony's Quality function
- Oversee and co-manage release testing and stability programs for drug substance and drug product with Quality Assurance
- Ensure COs meet Harmony business objectives while meeting quality and compliance standards
- Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility
- Review and maintain lifecycle product documentation and data files related to analytical activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, certificates, etc.
- Work closely with the Project Manager and Contract Organizations (CMOs/CROs) to ensure all analytical deliverables are aligned and meet agreed project timelines. Apply Quality by Design (QBD) principles and Design of Experiments (DoE) to develop robust analytical methods.
- Trend, analyze, and statistically interpret stability data.
- Identify degradation pathways and variability drivers.
- Establish scientifically justified shelf-life projections.
- Collaborate with other Harmony departments as required to:
- Achieve corporate goals and mission for uninterrupted clinical and commercial supply to patients
- Work closely with teams to define analytical testing strategy
- Develop and maintain technical aspects of quality agreements
- Implement analytical improvement or analytical aspects of other product lifecycle programs
- Lead the execution of analytical technology transfers, method implementation, qualification/validation
- Prepare and review dossiers for regulatory filings
- Drive fiscal responsibility with the operational budget and cost savings initiatives
Qualifications:
- Bachelor's degree in in Analytical Chemistry (or related field) with 8+ years of relevant industry experience; Master's degree with 5+ years of relevant industry experience; or PhD with 2+ years of relevant industry experience.
- Technical Proficiency in analytical method development, including dissolution testing, chromatographic techniques (such as HPLC, and GC), and spectroscopy methods (such as UV-Vis, NMF, MS, along with expertise in method robustness and qualification/validation requirements. Experience managing a contract manufacturing organization (CMO) is a plus.
- Knowledge and application of pharmaceutical analytical development principles, concepts, and industry practices to assist during audits or vendor inspections, and offer solutions to troubleshoot technical problems
- Experience in developing and transferring analytical methods from R&D to the commercial stage of the product lifecycle
- Knowledge of regulatory environment (FDA/ICH regulations) and experience with organizing and writing regulatory submissions
- Knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated quality guidance and principles (ICH, USP, and ISO standards), with particular emphasis on laboratory techniques and procedures
- Strong computer, organizational, and analytical skills required
Physical demands and work environment:
- Travel (both domestic and international) is estimated to be 20% of the time for this position; Candidate must be able to maintain or obtain valid US Passport within 90 days of hire date
- While performing the duties of this job, the noise level in the work environment is usually quiet.
- Specific vision abilities required by this job include: Close vision.
- Manual dexterity required to use computers, tablets, and cell phone.
- The employee must occasionally lift and /or move more than 20 pounds.
- Continuous sitting for prolonged periods.
What can Harmony offer you?
- Medical, Vision and Dental benefits the first of the month following start date
- Generous paid time off and Company designated Holidays
- Company paid Disability benefits and Life Insurance coverage
- 401(k) Retirement Savings Plan
- Paid Parental leave
- Employee Stock Purchase Plan (ESPP)
- Company sponsored wellness programs
- Professional development initiatives and continuous learning opportunities
- A certified Great Place to Work for eight consecutive years based on our positive, values-based company culture
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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com
Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
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About Harmony Biosciences
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Plymouth Meeting, PA, US
Year founded
2017